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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01431274
Other study ID # 1237.5
Secondary ID 2009-010668-40
Status Completed
Phase Phase 3
First received September 8, 2011
Last updated June 19, 2015
Start date September 2011
Est. completion date September 2013

Study information

Verified date June 2015
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia MedicaAustralia: Responsible Ethics CommitteeBulgaria: Bulgarian Drug AgencyCanada: Health CanadaChina: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlDenmark: The Danish Health and Medicines AuthorityEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyFrance: Agence Nationale sécurité médicament et des produits santéGermany: Federal Institute for Drugs and Medical DevicesGuatemala: Ministry of Public Health and Social AssistanceHungary: National Institute of PharmacyIndia: Drugs Controller General of IndiaItaly: Ethics CommitteeJapan: Ministry of Health, Labor and WelfareMexico: Federal Commission for Sanitary Risks ProtectionNetherlands: Central Committee Research Involving Human SubjectsNew Zealand: MedsafePortugal: National Pharmacy and Medicines InstituteRussia: Pharmacological Committee, Ministry of HealthSlovenia: Agency for Medicinal Products - Ministry of HealthSouth Korea: Ministry of Food and Drug Safety (MFDS)Turkey: Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).


Recruitment information / eligibility

Status Completed
Enrollment 2624
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease.

2. Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.

3. Male or female patients, 40 years of age or older.

4. Smoking history of more than 10 pack years.

Exclusion criteria:

1. Significant disease other than COPD

2. Clinically relevant abnormal lab values.

3. History of asthma.

4. Diagnosis of thyrotoxicosis

5. Diagnosis of paroxysmal tachycardia

6. History of myocardial infarction within 1 year of screening visit

7. Unstable or life-threatening cardiac arrhythmia.

8. Hospitalization for heart failure within the past year.

9. Known active tuberculosis.

10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years

11. History of life-threatening pulmonary obstruction.

12. History of cystic fibrosis.

13. Clinically evident bronchiectasis.

14. History of significant alcohol or drug abuse.

15. Thoracotomy with pulmonary resection

16. Oral ß-adrenergics.

17. Oral corticosteroid medication at unstable doses

18. Regular use of daytime oxygen therapy for more than one hour per day

19. Pulmonary rehabilitation program in the six weeks prior to the screening visit

20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit

21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA

22. Pregnant or nursing women.

23. Women of childbearing potential not using a highly effective method of birth control

24. Patients who are unable to comply with pulmonary medication restrictions

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
tiotropium + olodaterol
fixed dose combination
tiotropium
low dose
olodaterol
one dose only
tiotropium
high dose
tiotropium + olodaterol
fixed dose combination
Device:
Respimat
Respimat inhaler

Locations

Country Name City State
Argentina 1237.5.54010 Boehringer Ingelheim Investigational Site Buenos Aires
Argentina 1237.5.54013 Boehringer Ingelheim Investigational Site Caba
Argentina 1237.5.54016 Boehringer Ingelheim Investigational Site Caba
Argentina 1237.5.54003 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1237.5.54002 Boehringer Ingelheim Investigational Site Cuidad Autonoma de Buenos Airess A
Argentina 1237.5.54006 Boehringer Ingelheim Investigational Site Mar del Plata
Argentina 1237.5.54007 Boehringer Ingelheim Investigational Site Mar del Plata
Argentina 1237.5.54009 Boehringer Ingelheim Investigational Site Mendoza
Argentina 1237.5.54012 Boehringer Ingelheim Investigational Site Monte Grande
Argentina 1237.5.54008 Boehringer Ingelheim Investigational Site Quilmes
Argentina 1237.5.54005 Boehringer Ingelheim Investigational Site Rosario
Argentina 1237.5.54004 Boehringer Ingelheim Investigational Site San Miguel de Tucuma
Argentina 1237.5.54011 Boehringer Ingelheim Investigational Site San Miguel de Tucuman
Australia 1237.5.61004 Boehringer Ingelheim Investigational Site Frankston Victoria
Australia 1237.5.61001 Boehringer Ingelheim Investigational Site Toorak Gardens South Australia
Australia 1237.5.61002 Boehringer Ingelheim Investigational Site Woodville South Australia
Bulgaria 1237.5.35905 Boehringer Ingelheim Investigational Site Plovdiv
Bulgaria 1237.5.35901 Boehringer Ingelheim Investigational Site Rousse
Bulgaria 1237.5.35906 Boehringer Ingelheim Investigational Site Shumen
Bulgaria 1237.5.35902 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1237.5.35904 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1237.5.35903 Boehringer Ingelheim Investigational Site Troyan
Bulgaria 1237.5.35908 Boehringer Ingelheim Investigational Site Veliko Tarnovo
Canada 1237.5.02005 Boehringer Ingelheim Investigational Site Burlington Ontario
Canada 1237.5.02002 Boehringer Ingelheim Investigational Site Calgary Alberta
Canada 1237.5.02007 Boehringer Ingelheim Investigational Site Grimsby Ontario
Canada 1237.5.02011 Boehringer Ingelheim Investigational Site Ottawa Ontario
Canada 1237.5.02003 Boehringer Ingelheim Investigational Site Quebec
Canada 1237.5.02006 Boehringer Ingelheim Investigational Site Quebec
Canada 1237.5.02009 Boehringer Ingelheim Investigational Site Saskatoon Saskatchewan
Canada 1237.5.02008 Boehringer Ingelheim Investigational Site Sherbrooke Quebec
Canada 1237.5.02001 Boehringer Ingelheim Investigational Site Vancouver British Columbia
Canada 1237.5.02004 Boehringer Ingelheim Investigational Site Winnipeg Manitoba
China 1237.5.86003 Boehringer Ingelheim Investigational Site Beijing
China 1237.5.86004 Boehringer Ingelheim Investigational Site Beijing
China 1237.5.86011 Boehringer Ingelheim Investigational Site Changsha
China 1237.5.86012 Boehringer Ingelheim Investigational Site Changsha
China 1237.5.86014 Boehringer Ingelheim Investigational Site Foshan
China 1237.5.86001 Boehringer Ingelheim Investigational Site Guangzhou
China 1237.5.86015 Boehringer Ingelheim Investigational Site Nan Ning
China 1237.5.86002 Boehringer Ingelheim Investigational Site Shanghai
China 1237.5.86005 Boehringer Ingelheim Investigational Site Shanghai
China 1237.5.86006 Boehringer Ingelheim Investigational Site Shanghai
China 1237.5.86007 Boehringer Ingelheim Investigational Site Shanghai
China 1237.5.86009 Boehringer Ingelheim Investigational Site Shenyang
China 1237.5.86016 Boehringer Ingelheim Investigational Site Wuhan
China 1237.5.86010 Boehringer Ingelheim Investigational Site Xi'An
China 1237.5.86008 Boehringer Ingelheim Investigational Site Yangzhou
China 1237.5.86017 Boehringer Ingelheim Investigational Site Yinchuan
Czech Republic 1237.5.42004 Boehringer Ingelheim Investigational Site Beroun
Czech Republic 1237.5.42002 Boehringer Ingelheim Investigational Site Cvikov
Czech Republic 1237.5.42001 Boehringer Ingelheim Investigational Site Praha 6
Czech Republic 1237.5.42005 Boehringer Ingelheim Investigational Site Rokycany
Czech Republic 1237.5.42003 Boehringer Ingelheim Investigational Site Znojmo
Denmark 1237.5.45002 Boehringer Ingelheim Investigational Site Aalborg
Denmark 1237.5.45009 Boehringer Ingelheim Investigational Site Hvidovre
Denmark 1237.5.45001 Boehringer Ingelheim Investigational Site København NV
Denmark 1237.5.45007 Boehringer Ingelheim Investigational Site Kolding
Denmark 1237.5.45011 Boehringer Ingelheim Investigational Site Næstved
Denmark 1237.5.45006 Boehringer Ingelheim Investigational Site Odense C
Denmark 1237.5.45008 Boehringer Ingelheim Investigational Site Roskilde
Denmark 1237.5.45003 Boehringer Ingelheim Investigational Site Silkeborg
Denmark 1237.5.45005 Boehringer Ingelheim Investigational Site Sønderborg
Denmark 1237.5.45004 Boehringer Ingelheim Investigational Site Vaerløse
Estonia 1237.5.37002 Boehringer Ingelheim Investigational Site Tallin
Estonia 1237.5.37001 Boehringer Ingelheim Investigational Site Tartu
Finland 1237.5.35801 Boehringer Ingelheim Investigational Site Helsinki
Finland 1237.5.35804 Boehringer Ingelheim Investigational Site Pori
Finland 1237.5.35802 Boehringer Ingelheim Investigational Site Turku
France 1237.5.33004 Boehringer Ingelheim Investigational Site Bethune Cedex
France 1237.5.33007 Boehringer Ingelheim Investigational Site Montpellier cedex 5
France 1237.5.33005 Boehringer Ingelheim Investigational Site Nantes
France 1237.5.33006 Boehringer Ingelheim Investigational Site Nîmes cedex 9
France 1237.5.33008 Boehringer Ingelheim Investigational Site Perpignan
France 1237.5.33001 Boehringer Ingelheim Investigational Site Saint Pierre Cedex
France 1237.5.33002 Boehringer Ingelheim Investigational Site Strasbourg
Germany 1237.5.49006 Boehringer Ingelheim Investigational Site Bamberg
Germany 1237.5.49002 Boehringer Ingelheim Investigational Site Berlin
Germany 1237.5.49003 Boehringer Ingelheim Investigational Site Berlin
Germany 1237.5.49013 Boehringer Ingelheim Investigational Site Berlin
Germany 1237.5.49011 Boehringer Ingelheim Investigational Site Erfurt
Germany 1237.5.49005 Boehringer Ingelheim Investigational Site Hamburg
Germany 1237.5.49010 Boehringer Ingelheim Investigational Site Hamburg
Germany 1237.5.49009 Boehringer Ingelheim Investigational Site Koblenz
Germany 1237.5.49014 Boehringer Ingelheim Investigational Site Neu-Isenburg
Germany 1237.5.49012 Boehringer Ingelheim Investigational Site Oschersleben
Germany 1237.5.49001 Boehringer Ingelheim Investigational Site Rüdersdorf
Germany 1237.5.49004 Boehringer Ingelheim Investigational Site Weinheim
Germany 1237.5.49008 Boehringer Ingelheim Investigational Site Wiesloch
Guatemala 1237.5.50201 Boehringer Ingelheim Investigational Site Guatemala
Guatemala 1237.5.50202 Boehringer Ingelheim Investigational Site Guatemala
Guatemala 1237.5.50203 Boehringer Ingelheim Investigational Site Guatemala
Guatemala 1237.5.50204 Boehringer Ingelheim Investigational Site Guatemala
Guatemala 1237.5.50205 Boehringer Ingelheim Investigational Site Guatemala
Guatemala 1237.5.50206 Boehringer Ingelheim Investigational Site Guatemala
Guatemala 1237.5.50207 Boehringer Ingelheim Investigational Site Guatemala
Hungary 1237.5.36005 Boehringer Ingelheim Investigational Site Debrecen
Hungary 1237.5.36001 Boehringer Ingelheim Investigational Site Deszk
Hungary 1237.5.36006 Boehringer Ingelheim Investigational Site Kapuvar
Hungary 1237.5.36003 Boehringer Ingelheim Investigational Site Szombathely
Hungary 1237.5.36002 Boehringer Ingelheim Investigational Site Törökbalint
India 1237.5.91010 Boehringer Ingelheim Investigational Site Ahmedabad
India 1237.5.91002 Boehringer Ingelheim Investigational Site Bangalore
India 1237.5.91007 Boehringer Ingelheim Investigational Site Bangalore
India 1237.5.91004 Boehringer Ingelheim Investigational Site Coimbatore
India 1237.5.91011 Boehringer Ingelheim Investigational Site Hyderabad
India 1237.5.91001 Boehringer Ingelheim Investigational Site Jaipur
India 1237.5.91008 Boehringer Ingelheim Investigational Site Jaipur
India 1237.5.91009 Boehringer Ingelheim Investigational Site Mysore
India 1237.5.91006 Boehringer Ingelheim Investigational Site Pune
Italy 1237.5.39008 Boehringer Ingelheim Investigational Site Cagliari
Italy 1237.5.39002 Boehringer Ingelheim Investigational Site Genova
Italy 1237.5.39006 Boehringer Ingelheim Investigational Site Montescano (PV)
Italy 1237.5.39009 Boehringer Ingelheim Investigational Site Monza
Italy 1237.5.39004 Boehringer Ingelheim Investigational Site Parma
Italy 1237.5.39001 Boehringer Ingelheim Investigational Site Pisa
Japan 1237.5.81003 Boehringer Ingelheim Investigational Site Aoba-ku, Sendai, Miyagi
Japan 1237.5.81001 Boehringer Ingelheim Investigational Site Asahikawa, Hokkaido
Japan 1237.5.81006 Boehringer Ingelheim Investigational Site Bunkyo-ku, Tokyo
Japan 1237.5.81044 Boehringer Ingelheim Investigational Site Chuo-ku, Kumamoto, Kumamoto
Japan 1237.5.81035 Boehringer Ingelheim Investigational Site Gifu, Gifu
Japan 1237.5.81017 Boehringer Ingelheim Investigational Site Hakata-ku, Fukuoka, Fukuoka
Japan 1237.5.81031 Boehringer Ingelheim Investigational Site Hamamatsushi, Shizuoka
Japan 1237.5.81014 Boehringer Ingelheim Investigational Site Himeji, Hyogo
Japan 1237.5.81037 Boehringer Ingelheim Investigational Site Ikoma, Nara
Japan 1237.5.81024 Boehringer Ingelheim Investigational Site Inashiki-gun, Ibaraki
Japan 1237.5.81008 Boehringer Ingelheim Investigational Site Itabashi-ku, Tokyo
Japan 1237.5.81016 Boehringer Ingelheim Investigational Site Jonan-ku, Fukuoka, Fukuoka
Japan 1237.5.81021 Boehringer Ingelheim Investigational Site Kagoshima, Kagoshima
Japan 1237.5.81020 Boehringer Ingelheim Investigational Site Kagoshima, Kagoshima,
Japan 1237.5.81005 Boehringer Ingelheim Investigational Site Kamogawa, Chiba
Japan 1237.5.81011 Boehringer Ingelheim Investigational Site Kishiwada, Osaka
Japan 1237.5.81018 Boehringer Ingelheim Investigational Site Kitakyusyu,Fukuoka
Japan 1237.5.81042 Boehringer Ingelheim Investigational Site Koga, Fukuoka
Japan 1237.5.81032 Boehringer Ingelheim Investigational Site Komaki, Aichi
Japan 1237.5.81033 Boehringer Ingelheim Investigational Site Komaki, Aichi
Japan 1237.5.81019 Boehringer Ingelheim Investigational Site Koshi, Kumamoto
Japan 1237.5.81027 Boehringer Ingelheim Investigational Site koto-ku, Tokyo
Japan 1237.5.81025 Boehringer Ingelheim Investigational Site Kuki, Saitama
Japan 1237.5.81038 Boehringer Ingelheim Investigational Site Kure, Hiroshima
Japan 1237.5.81015 Boehringer Ingelheim Investigational Site Kurume, Fukuoka
Japan 1237.5.81029 Boehringer Ingelheim Investigational Site Matsumoto, Nagano
Japan 1237.5.81030 Boehringer Ingelheim Investigational Site Matsumoto, Nagano
Japan 1237.5.81010 Boehringer Ingelheim Investigational Site Matsusaka, Mie
Japan 1237.5.81041 Boehringer Ingelheim Investigational Site Minami-ku. Fukuoka, Fukuoka
Japan 1237.5.81002 Boehringer Ingelheim Investigational Site Morioka, Iwate
Japan 1237.5.81034 Boehringer Ingelheim Investigational Site Nagoya, Aichi
Japan 1237.5.81036 Boehringer Ingelheim Investigational Site Nagoya, Aichi
Japan 1237.5.81004 Boehringer Ingelheim Investigational Site Naka-gun, Ibaraki
Japan 1237.5.81022 Boehringer Ingelheim Investigational Site Okinawa, Urasoe
Japan 1237.5.81023 Boehringer Ingelheim Investigational Site Okinawa, Urasoe
Japan 1237.5.81012 Boehringer Ingelheim Investigational Site Sayama, Osaka
Japan 1237.5.81045 Boehringer Ingelheim Investigational Site Sendai, Miyagi
Japan 1237.5.81009 Boehringer Ingelheim Investigational Site Seto, Aichi
Japan 1237.5.81026 Boehringer Ingelheim Investigational Site Shinagawa, Tokyo
Japan 1237.5.81007 Boehringer Ingelheim Investigational Site Shinjyuku-ku, Tokyo
Japan 1237.5.81039 Boehringer Ingelheim Investigational Site Takamatsu, Kagawa
Japan 1237.5.81040 Boehringer Ingelheim Investigational Site Takamatsu, Kagawa
Japan 1237.5.81013 Boehringer Ingelheim Investigational Site Wakayama, Wakayama
Japan 1237.5.81043 Boehringer Ingelheim Investigational Site Yanagawa-shi, Fukuoka,
Japan 1237.5.81028 Boehringer Ingelheim Investigational Site Yokohama, Kanagawa
Korea, Republic of 1237.5.82004 Boehringer Ingelheim Investigational Site Bucheon
Korea, Republic of 1237.5.82008 Boehringer Ingelheim Investigational Site Daegu
Korea, Republic of 1237.5.82001 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1237.5.82002 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1237.5.82003 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1237.5.82007 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1237.5.82005 Boehringer Ingelheim Investigational Site Suwon
Korea, Republic of 1237.5.82006 Boehringer Ingelheim Investigational Site Wonju
Mexico 1237.5.52002 Boehringer Ingelheim Investigational Site Hermosillo
Mexico 1237.5.52003 Boehringer Ingelheim Investigational Site Mexico
Mexico 1237.5.52007 Boehringer Ingelheim Investigational Site Monterrey
Mexico 1237.5.52001 Boehringer Ingelheim Investigational Site Tijuana
Netherlands 1237.5.31004 Boehringer Ingelheim Investigational Site Almelo
Netherlands 1237.5.31006 Boehringer Ingelheim Investigational Site Breda
Netherlands 1237.5.31001 Boehringer Ingelheim Investigational Site Eindhoven
Netherlands 1237.5.31008 Boehringer Ingelheim Investigational Site Harderwijk
Netherlands 1237.5.31007 Boehringer Ingelheim Investigational Site Heerlen
Netherlands 1237.5.31010 Boehringer Ingelheim Investigational Site Hengelo
Netherlands 1237.5.31009 Boehringer Ingelheim Investigational Site Hoorn
Netherlands 1237.5.31005 Boehringer Ingelheim Investigational Site Nieuwegein
Netherlands 1237.5.31002 Boehringer Ingelheim Investigational Site Veldhoven
Netherlands 1237.5.31003 Boehringer Ingelheim Investigational Site Zutphen
New Zealand 1237.5.64002 Boehringer Ingelheim Investigational Site Dunedin
New Zealand 1237.5.64001 Boehringer Ingelheim Investigational Site Greenlane East Auckland NZ
Portugal 1237.5.35105 Boehringer Ingelheim Investigational Site Amadora
Portugal 1237.5.35101 Boehringer Ingelheim Investigational Site Coimbra
Portugal 1237.5.35102 Boehringer Ingelheim Investigational Site Lisboa
Portugal 1237.5.35104 Boehringer Ingelheim Investigational Site Lisboa
Portugal 1237.5.35103 Boehringer Ingelheim Investigational Site Porto
Portugal 1237.5.35106 Boehringer Ingelheim Investigational Site Vila Nova de Gaia
Portugal 1237.5.35107 Boehringer Ingelheim Investigational Site Viseu
Russian Federation 1237.5.07001 Boehringer Ingelheim Investigational Site Gatchina (Leningradskaya oblast)
Russian Federation 1237.5.07003 Boehringer Ingelheim Investigational Site Kazan
Russian Federation 1237.5.07004 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1237.5.07005 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1237.5.07002 Boehringer Ingelheim Investigational Site St. Petersburg
Slovenia 1237.5.38601 Boehringer Ingelheim Investigational Site Golnik
Slovenia 1237.5.38602 Boehringer Ingelheim Investigational Site Golnik
Turkey 1237.5.90003 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1237.5.90004 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1237.5.90002 Boehringer Ingelheim Investigational Site Izmir
Turkey 1237.5.90005 Boehringer Ingelheim Investigational Site Izmit
Turkey 1237.5.90001 Boehringer Ingelheim Investigational Site Mersin
United States 1237.5.01017 Boehringer Ingelheim Investigational Site Biddeford Maine
United States 1237.5.01015 Boehringer Ingelheim Investigational Site Boulder Colorado
United States 1237.5.01032 Boehringer Ingelheim Investigational Site Charleston Pennsylvania
United States 1237.5.01006 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1237.5.01003 Boehringer Ingelheim Investigational Site Clearwater Florida
United States 1237.5.01010 Boehringer Ingelheim Investigational Site Clearwater Florida
United States 1237.5.01028 Boehringer Ingelheim Investigational Site Columbia Maryland
United States 1237.5.01040 Boehringer Ingelheim Investigational Site Columbus Ohio
United States 1237.5.01039 Boehringer Ingelheim Investigational Site Dayton Ohio
United States 1237.5.01021 Boehringer Ingelheim Investigational Site Easley South Carolina
United States 1237.5.01029 Boehringer Ingelheim Investigational Site Ft. Worth Texas
United States 1237.5.01012 Boehringer Ingelheim Investigational Site Gaffney South Carolina
United States 1237.5.01038 Boehringer Ingelheim Investigational Site Jasper Alabama
United States 1237.5.01005 Boehringer Ingelheim Investigational Site Johnston Rhode Island
United States 1237.5.01025 Boehringer Ingelheim Investigational Site Larchmont New York
United States 1237.5.01013 Boehringer Ingelheim Investigational Site Livonia Michigan
United States 1237.5.01026 Boehringer Ingelheim Investigational Site Lynchburg Virginia
United States 1237.5.01036 Boehringer Ingelheim Investigational Site Mobile Alabama
United States 1237.5.01001 Boehringer Ingelheim Investigational Site Morgantown West Virginia
United States 1237.5.01031 Boehringer Ingelheim Investigational Site O'Fallon Illinois
United States 1237.5.01009 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma
United States 1237.5.01019 Boehringer Ingelheim Investigational Site Omaha Nebraska
United States 1237.5.01035 Boehringer Ingelheim Investigational Site Opelousas Louisiana
United States 1237.5.01027 Boehringer Ingelheim Investigational Site Panama City Florida
United States 1237.5.01023 Boehringer Ingelheim Investigational Site Raleigh North Carolina
United States 1237.5.01008 Boehringer Ingelheim Investigational Site Rochester New York
United States 1237.5.01002 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1237.5.01004 Boehringer Ingelheim Investigational Site Shreveport Louisiana
United States 1237.5.01014 Boehringer Ingelheim Investigational Site Spartanburg South Carolina
United States 1237.5.01007 Boehringer Ingelheim Investigational Site Spokane Washington
United States 1237.5.01034 Boehringer Ingelheim Investigational Site Stamford Connecticut
United States 1237.5.01016 Boehringer Ingelheim Investigational Site Tabor City North Carolina
United States 1237.5.01033 Boehringer Ingelheim Investigational Site Tacoma Washington
United States 1237.5.01037 Boehringer Ingelheim Investigational Site Toledo Ohio
United States 1237.5.01024 Boehringer Ingelheim Investigational Site Wheat Ridge Colorado

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Canada,  China,  Czech Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Guatemala,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Portugal,  Russian Federation,  Slovenia,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169. FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the MMRM model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169. No
Primary Trough FEV1 Response on Day 170. Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FEV1 measurements performed at 23 h and at 23 h 50 min after inhalation of study medication at the clinic visit on the previous day.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170 No
Primary Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group. Day 169 No
Secondary Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) Mahler Transitional Dyspnoea Index (TDI) focal score on Day 169 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) is the key secondary endpoint.
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
Day 169 No
Secondary FEV1 AUC(0-3h) Response on Day 1 FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment. No
Secondary FEV1 AUC(0-3h) Response on Day 85 FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85. No
Secondary FEV1 AUC(0-3h) Response on Day 365 FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365. No
Secondary Trough FEV1 Response on Day 15. Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed
1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15 No
Secondary Trough FEV1 Response on Day 43 Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed
1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43. No
Secondary Trough FEV1 Response on Day 85 Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed
1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 85. No
Secondary Trough FEV1 Response on Day 169 Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed
1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on Day 169 No
Secondary Trough FEV1 Response on Day 365 Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed
1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365 No
Secondary FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 1 FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment. No
Secondary FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 85 FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85. No
Secondary FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 169 FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169. No
Secondary FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 365 FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.
FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365. No
Secondary Trough FVC Response on Day 15. Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15 No
Secondary Trough FVC Response on Day 43. Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43 No
Secondary Trough FVC Response on Day 85. Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85 No
Secondary Trough FVC Response on Day 170. Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FVC measurements performed at 23h and at 23h 50 min after inhalation of study medication at the clinic visit on the previous day.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170 No
Secondary Trough FVC Response on Day 365. Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.
Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.
The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.
1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on Day 365. No
Secondary FEV1 AUC(0-12h) Response in the Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) FEV1 AUC(0-12h) was calculated as the area under the FEV1- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
FEV1 AUC(0-12h) response was defined as FEV1 AUC(0-12h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169. No
Secondary FEV1 AUC(0-24h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) FEV1 AUC(0-24h) was calculated as the area under the FEV1- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FEV1 AUC(0-24h) response was defined as FEV1 AUC(0-24h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169. No
Secondary FVC AUC(0-12h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) FVC AUC(0-12h) was calculated as the area under the FVC- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
FVC AUC(0-12h) response was defined as FVC AUC(0-12h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169. No
Secondary FVC AUC(0-24h) Response in Sub-set of Patients With 24-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) FVC AUC(0-24h) was calculated as the area under the FVC- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.
FVC AUC(0-24h) response was defined as FVC AUC(0-24h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).
The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.
Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group.
1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169. No
Secondary Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group. Day 85 No
Secondary Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group. Day 365 No
Secondary Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) Mahler Transitional Dyspnoea Index (TDI) focal score on Day 43 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
Day 43 No
Secondary Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) Mahler Transitional Dyspnoea Index (TDI) focal score on Day 85 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.
Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
Day 85 No
Secondary Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) Mahler Transitional Dyspnoea Index (TDI) focal score on Day 365 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).
The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.
Day 365 No
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