Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400153
• Other study ID #: 1012.56
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2006
• Last updated: June 9, 2014
• Start date: November 2006

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)New Zealand: Multicentre Ethics Committee/MedsafeUnited States: Food and Drug AdministrationFrance: AFSSAPSGreece: National Organization for Medicines (EOF) National Ethics CommitteeArgentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología)Taiwan: Department of Health, Executive Yuan, TaiwanKorea, Republic of: Korea Food and Drug AdministrationTurkey: Ministry of Health Central Ethics CommitteeGreat Britain: MHRASouth Africa: MCC (Medicines Control Council)
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.

Other known NCT identifiers

• NCT00847652

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1480
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).

Exclusion Criteria:

Patients with significant diseases other than COPD that may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Atrovent Respimat (20 mcg)

• COMBIVENT MDI (36/206 mcg)

• Combivent Respimat (20 mcg/100 mcg)

• Placebo via corresponding inhaler for blinding purposes

Locations

Country	Name	City	State
Argentina	1012.56.54001 Centro Médico de la Dra. De Salvo	Capital Federal
Argentina	1012.56.54002 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1012.56.54003 Policlínica Bancaria	Capital Federal
Argentina	1012.56.54004 Hospital Ramos Mejia	Capital Federal
Argentina	1012.56.54010 Instituto Lanari	Capital Federal
Argentina	1012.56.54011 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1012.56.54015 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1012.56.54005 Instituto de Diagnóstico Cardiovascular La Plata	La Plata
Argentina	1012.56.54012 Boehringer Ingelheim Investigational Site	Lanús
Argentina	1012.56.54009 Instituto de Investigaciones Clínicas	Mar del Plata
Argentina	1012.56.54014 Boehringer Ingelheim Investigational Site	Mendoza
Argentina	1012.56.54007 CLINICA PRIVADA de MONTE GRANDE	Monte Grande
Argentina	1012.56.54006 CENTRO PRIVADO de MEDICINA RESPIRATORIA	Paraná
Argentina	1012.56.54008 HOSPITAL ITALIANO de ROSARIO	Rosario
Argentina	1012.56.54013 Boehringer Ingelheim Investigational Site	San Miguel de Tucumán
France	1012.56.3305A Centre hospitalier Germon & Gauthier	Béthune
France	1012.56.3303A Clinique de la Louvière	Lille Cedex
France	1012.56.3301A Hôpital Ambroise Paré	Marseille
France	1012.56.3304A Centre Médical Erdre Saint Augustin	Nantes
France	1012.56.3302A Cabinet Médical	Nice
France	1012.56.3302B Cabinet Médical	Nice
Greece	1012.56.30001 Boehringer Ingelheim Investigational Site	Athens
Greece	1012.56.30011 Boehringer Ingelheim Investigational Site	Athens
Greece	1012.56.30013 Boehringer Ingelheim Investigational Site	Athens
Greece	1012.56.30009 Boehringer Ingelheim Investigational Site	Heraklion
Greece	1012.56.30007 Boehringer Ingelheim Investigational Site	Komotini
Greece	1012.56.30010 Boehringer Ingelheim Investigational Site	Korinthos
Greece	1012.56.30002 Boehringer Ingelheim Investigational Site	Larissa
Greece	1012.56.30014 Boehringer Ingelheim Investigational Site	Nafplio
Greece	1012.56.30003 Boehringer Ingelheim Investigational Site	Thessaloniki
Korea, Republic of	1012.56.82009 Boehringer Ingelheim Investigational Site	Daegu
Korea, Republic of	1012.56.82010 Boehringer Ingelheim Investigational Site	Geonggi-Do
Korea, Republic of	1012.56.82008 Boehringer Ingelheim Investigational Site	Gyeonggi-Do
Korea, Republic of	1012.56.82001 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1012.56.82002 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1012.56.82005 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1012.56.82006 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1012.56.82007 Boehringer Ingelheim Investigational Site	Seoul
New Zealand	1012.56.64004 Boehringer Ingelheim Investigational Site	Dunedin
New Zealand	1012.56.64001 Boehringer Ingelheim Investigational Site	Grafton / Auckland
New Zealand	1012.56.64003 Boehringer Ingelheim Investigational Site	Hamilton
New Zealand	1012.56.64006 Boehringer Ingelheim Investigational Site	Tauranga
New Zealand	1012.56.64005 Boehringer Ingelheim Investigational Site	Wellington
Poland	1012.56.48009 Boehringer Ingelheim Investigational Site	Bydgoszcz
Poland	1012.56.48006 Boehringer Ingelheim Investigational Site	Krakow
Poland	1012.56.48007 Boehringer Ingelheim Investigational Site	Krakow
Poland	1012.56.48004 Boehringer Ingelheim Investigational Site	Ostrow Wielkopolska
Poland	1012.56.48005 Boehringer Ingelheim Investigational Site	Poznan
Poland	1012.56.48002 Boehringer Ingelheim Investigational Site	Proszowice
Poland	1012.56.48010 Boehringer Ingelheim Investigational Site	Radom
Poland	1012.56.48001 Boehringer Ingelheim Investigational Site	Warsaw
Poland	1012.56.48011 Boehringer Ingelheim Investigational Site	Warsaw
Poland	1012.56.48003 Boehringer Ingelheim Investigational Site	Wroclaw
Russian Federation	1012.56.07010 Boehringer Ingelheim Investigational Site	Kazan
Russian Federation	1012.56.07001 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1012.56.07002 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1012.56.07003 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1012.56.07005 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1012.56.07007 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1012.56.07008 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1012.56.07009 Boehringer Ingelheim Investigational Site	St.Petersburg
South Africa	1012.56.27002 Boehringer Ingelheim Investigational Site	Bellville
South Africa	1012.56.27008 Boehringer Ingelheim Investigational Site	Boksburg
South Africa	1012.56.27001 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1012.56.27004 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1012.56.27005 Boehringer Ingelheim Investigational Site	Johannesburg
South Africa	1012.56.27009 Boehringer Ingelheim Investigational Site	Orange Grove
South Africa	1012.56.27003 Boehringer Ingelheim Investigational Site	Paarl
South Africa	1012.56.27006 Boehringer Ingelheim Investigational Site	Park Town West
Taiwan	1012.56.88604 Chang Gong Memorial Hospital	Keelong Town
Taiwan	1012.56.88605 Taichung Veterans General Hospital	Taichung
Taiwan	1012.56.88602 Taipei Veterans General Hospital	Taipei
Taiwan	1012.56.88603 National Taiwan University Hospital	Taipei
Taiwan	1012.56.88601 Chang Gung Memorial Hosp-Linkou	Taoyuan
Turkey	1012.56.90001 Boehringer Ingelheim Investigational Site	Ankara
Turkey	1012.56.90005 Boehringer Ingelheim Investigational Site	Antalya
Turkey	1012.56.90003 Boehringer Ingelheim Investigational Site	Istanbul
Turkey	1012.56.90006 Boehringer Ingelheim Investigational Site	Istanbul
Turkey	1012.56.90002 Boehringer Ingelheim Investigational Site	Mersin
Ukraine	1012.56.38005 Boehringer Ingelheim Investigational Site	Dnyepropyetrovsk
Ukraine	1012.56.38006 Boehringer Ingelheim Investigational Site	Donetsk
Ukraine	1012.56.38001 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1012.56.38002 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1012.56.38004 Boehringer Ingelheim Investigational Site	Kiev
United Kingdom	1012.56.44009 Boehringer Ingelheim Investigational Site	Ballieston, Glasgow
United Kingdom	1012.56.44003 Boehringer Ingelheim Investigational Site	Bury St Edmonds
United Kingdom	1012.56.44002 Boehringer Ingelheim Investigational Site	Cambridge
United Kingdom	1012.56.44006 Colchester General Hospital	Colchester
United Kingdom	1012.56.44007 Boehringer Ingelheim Investigational Site	Doncaster
United Kingdom	1012.56.44001 Medicine Evaluation Unit	Manchester
United Kingdom	1012.56.44008 The Staploe Medical Centre	Soham
United Kingdom	1012.56.44005 Morriston Hospital	Swansea
United Kingdom	1012.56.44010 Boehringer Ingelheim Investigational Site	Windsor
United States	1012.56.01069 Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico
United States	1012.56.01079 Boehringer Ingelheim Investigational Site	Ann Arbor	Michigan
United States	1012.56.01078 Boehringer Ingelheim Investigational Site	Asheville	North Carolina
United States	1012.56.01077 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	1012.56.01035 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	1012.56.01007 Boehringer Ingelheim Investigational Site	Bay Pines	Florida
United States	1012.56.01063 Boehringer Ingelheim Investigational Site	Bellington	Washington
United States	1012.56.01006 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	1012.56.01066 Boehringer Ingelheim Investigational Site	Bowling Green	Kentucky
United States	1012.56.01058 Boehringer Ingelheim Investigational Site	Brandon	Florida
United States	1012.56.01080 Boehringer Ingelheim Investigational Site	Brick	New Jersey
United States	1012.56.01026 Boehringer Ingelheim Investigational Site	Charleston	South Carolina
United States	1012.56.01037 Boehringer Ingelheim Investigational Site	Charleston	South Carolina
United States	1012.56.01027 Boehringer Ingelheim Investigational Site	Cherry Hill	New Jersey
United States	1012.56.01010 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	1012.56.01065 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	1012.56.01008 Boehringer Ingelheim Investigational Site	Coeur D'Alene	Idaho
United States	1012.56.01083 Boehringer Ingelheim Investigational Site	Decatur	Georgia
United States	1012.56.01024 Boehringer Ingelheim Investigational Site	Deland	Florida
United States	1012.56.01040 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	1012.56.01087 Boehringer Ingelheim Investigational Site	East Providence	Rhode Island
United States	1012.56.01050 Boehringer Ingelheim Investigational Site	Fort Collins	Colorado
United States	1012.56.01047 Boehringer Ingelheim Investigational Site	Fort Worth	Texas
United States	1012.56.01081 Boehringer Ingelheim Investigational Site	Greenville	South Carolina
United States	1012.56.01085 Boehringer Ingelheim Investigational Site	Greenville	South Carolina
United States	1012.56.01084 Boehringer Ingelheim Investigational Site	Greer	South Carolina
United States	1012.56.01036 Boehringer Ingelheim Investigational Site	Hartford	Connecticut
United States	1012.56.01082 Boehringer Ingelheim Investigational Site	Henderson	Nevada
United States	1012.56.01067 Boehringer Ingelheim Investigational Site	Hershey	Pennsylvania
United States	1012.56.01014 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1012.56.01051 Boehringer Ingelheim Investigational Site	Jasper	Alabama
United States	1012.56.01057 Boehringer Ingelheim Investigational Site	Johnston	Rhode Island
United States	1012.56.01032 Boehringer Ingelheim Investigational Site	Killeen	Texas
United States	1012.56.01090 Boehringer Ingelheim Investigational Site	Lafayette	Louisiana
United States	1012.56.01012 Boehringer Ingelheim Investigational Site	Lakewood	California
United States	1012.56.01022 Boehringer Ingelheim Investigational Site	Larchmont	New York
United States	1012.56.01029 Boehringer Ingelheim Investigational Site	Los Angeles	California
United States	1012.56.01016 Boehringer Ingelheim Investigational Site	Medford	Oregon
United States	1012.56.01001 Boehringer Ingelheim Investigational Site	Melbourne	Florida
United States	1012.56.01044 Boehringer Ingelheim Investigational Site	Minneapolis	Minnesota
United States	1012.56.01071 Boehringer Ingelheim Investigational Site	Mobile	Alabama
United States	1012.56.01074 Boehringer Ingelheim Investigational Site	Morgantown	West Virginia
United States	1012.56.01073 Boehringer Ingelheim Investigational Site	Nashville	Tennessee
United States	1012.56.01075 Boehringer Ingelheim Investigational Site	Nashville	Tennessee
United States	1012.56.01015 Boehringer Ingelheim Investigational Site	New Hyde Park	New York
United States	1012.56.01054 Boehringer Ingelheim Investigational Site	New Orleans	Louisiana
United States	1012.56.01072 Boehringer Ingelheim Investigational Site	New Orleans	Louisiana
United States	1012.56.01068 Boehringer Ingelheim Investigational Site	New York City	New York
United States	1012.56.01038 Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma
United States	1012.56.01019 Boehringer Ingelheim Investigational Site	Olathe	Kansas
United States	1012.56.01043 Boehringer Ingelheim Investigational Site	Palo Alto	California
United States	1012.56.01023 Boehringer Ingelheim Investigational Site	Panama City	Florida
United States	1012.56.01052 Boehringer Ingelheim Investigational Site	Pensecola	Florida
United States	1012.56.01003 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania
United States	1012.56.01060 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania
United States	1012.56.01039 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	1012.56.01004 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
United States	1012.56.01017 Boehringer Ingelheim Investigational Site	Raleigh	North Carolina
United States	1012.56.01089 Boehringer Ingelheim Investigational Site	Rancho Mirage	California
United States	1012.56.01049 Boehringer Ingelheim Investigational Site	Reno	Nevada
United States	1012.56.01009 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	1012.56.01013 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	1012.56.01021 Boehringer Ingelheim Investigational Site	Riverside	California
United States	1012.56.01059 Boehringer Ingelheim Investigational Site	Roanoke	Virginia
United States	1012.56.01055 Boehringer Ingelheim Investigational Site	Salem	Virginia
United States	1012.56.01002 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	1012.56.01053 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	1012.56.01033 Boehringer Ingelheim Investigational Site	San Jose	California
United States	1012.56.01020 Boehringer Ingelheim Investigational Site	Sepulveda	California
United States	1012.56.01070 Boehringer Ingelheim Investigational Site	Shreveport	Louisiana
United States	1012.56.01011 Boehringer Ingelheim Investigational Site	Spartanburg	South Carolina
United States	1012.56.01005 Boehringer Ingelheim Investigational Site	Spokane	Washington
United States	1012.56.01064 Boehringer Ingelheim Investigational Site	Spokane	Washington
United States	1012.56.01076 Boehringer Ingelheim Investigational Site	St. Louis	Missouri
United States	1012.56.01025 Boehringer Ingelheim Investigational Site	Stamford	Connecticut
United States	1012.56.01028 Boehringer Ingelheim Investigational Site	Summit	New Jersey
United States	1012.56.01034 Boehringer Ingelheim Investigational Site	Sylvania	Ohio
United States	1012.56.01030 Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	1012.56.01048 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	1012.56.01031 Boehringer Ingelheim Investigational Site	Toledo	Ohio
United States	1012.56.01045 Boehringer Ingelheim Investigational Site	Torrence	California
United States	1012.56.01088 Boehringer Ingelheim Investigational Site	Waterbury	Connecticut
United States	1012.56.01018 Boehringer Ingelheim Investigational Site	Wheat Ridge	Colorado
United States	1012.56.01062 Boehringer Ingelheim Investigational Site	Wheat Ridge	Colorado
United States	1012.56.01056 Boehringer Ingelheim Investigational Site	Wichita	Kansas
United States	1012.56.01042 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina
United States	1012.56.01093 Boehringer Ingelheim Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  France,  Greece,  Korea, Republic of,  New Zealand,  Poland,  Russian Federation,  South Africa,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 AUC0-6 at Day 85	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85	Before drug administration to 6 hours after drug administration on Day 85	No
Primary	FEV1 AUC0-4 at Day 85	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85	Before drug administration to 4 hours after drug administration on Day 85	No
Primary	FEV1 AUC4-6 at Day 85	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85	Between 4 hours and 6 hours after drug administration on Day 85	No
Secondary	FEV1 AUC0-6 at Day 1	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1	Before drug administration to 6 hours after drug administration on Day 1	No
Secondary	FEV1 AUC0-6 at Day 29	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29	Before drug administration to 6 hours after drug administration on Day 29	No
Secondary	FEV1 AUC0-6 at Day 57	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57	Before drug administration to 6 hours after drug administration on Day 57	No
Secondary	FEV1 AUC0-4 at Day 1	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1	Before drug administration to 4 hours after drug administration on Day 1	No
Secondary	FEV1 AUC0-4 at Day 29	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29	Before drug administration to 4 hours after drug administration on Day 29	No
Secondary	FEV1 AUC0-4 at Day 57	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57	Before drug administration to 4 hours after drug administration on Day 57	No
Secondary	FEV1 AUC4-6 at Day 1	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1	Between 4 hours and 6 hours after drug administration on Day 1	No
Secondary	FEV1 AUC4-6 at Day 29	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29	Between 4 hours and 6 hours after drug administration on Day 29	No
Secondary	FEV1 AUC4-6 at Day 57	Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57	Between 4 hours and 6 hours after drug administration on Day 57	No
Secondary	Peak FEV1 Response at Day 1	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1	Within the first 2-hour post-treatment interval on Day 1	No
Secondary	Peak FEV1 Response at Day 29	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29	Within the first 2-hour post-treatment interval on Day 29	No
Secondary	Peak FEV1 Response at Day 57	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57	Within the first 2-hour post-treatment interval on Day 57	No
Secondary	Peak FEV1 Response at Day 85	Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85	Within the first 2-hour post-treatment interval on Day 85	No
Secondary	Time to Onset of Therapeutic FEV1 Response at Day 1	Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1	Within the first 2-hour post-treatment interval at Day 1	No
Secondary	Time to Onset of Therapeutic FEV1 Response at Day 29	Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29	Within the first 2-hour post-treatment interval at Day 29	No
Secondary	Time to Onset of Therapeutic FEV1 Response at Day 57	Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57	Within the first 2-hour post-treatment interval at Day 57	No
Secondary	Time to Onset of Therapeutic FEV1 Response at Day 85	Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85	Within the first 2-hour post-treatment interval at Day 85	No
Secondary	Duration of Therapeutic FEV1 Response at Day 1	The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1	During the 6-hour observation period after drug administration at Day 1	No
Secondary	Duration of Therapeutic FEV1 Response at Day 29	The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29	During the 6-hour observation period after drug administration at Day 29	No
Secondary	Duration of Therapeutic FEV1 Response at Day 57	The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57	During the 6-hour observation period after drug administration at Day 57	No
Secondary	Duration of Therapeutic FEV1 Response at Day 85	The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85	During the 6-hour observation period after drug administration at Day 85	No
Secondary	Time to Peak FEV1 Response at Day 1	The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1	Within the 6-hour post-treatment observation period at Day 1	No
Secondary	Time to Peak FEV1 Response at Day 29	The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29	Within the 6-hour post-treatment observation period at Day 29	No
Secondary	Time to Peak FEV1 Response at Day 57	The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57	Within the 6-hour post-treatment observation period at Day 57	No
Secondary	Time to Peak FEV1 Response at Day 85	The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85	Within the 6-hour post-treatment observation period at Day 85	No
Secondary	FVC AUC0-6 at Day 1	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1	Before drug administration to 6 hours after drug administration at Day 1	No
Secondary	FVC AUC0-6 at Day 29	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29	Before drug administration to 6 hours after drug administration at Day 29	No
Secondary	FVC AUC0-6 at Day 57	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57	Before drug administration to 6 hours after drug administration on Day 57	No
Secondary	FVC AUC0-6 at Day 85	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85	Before drug administration to 6 hours after drug administration on Day 85	No
Secondary	FVC AUC0-4 at Day 1	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1	Before drug administration to 4 hours after drug administration on Day 1	No
Secondary	FVC AUC0-4 at Day 29	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29	Before drug administration to 4 hours after drug administration on Day 29	No
Secondary	FVC AUC0-4 at Day 57	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57	Before drug administration to 4 hours after drug administration on Day 57	No
Secondary	FVC AUC0-4 at Day 85	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85	Before drug administration to 4 hours after drug administration on Day 85	No
Secondary	FVC AUC4-6 at Day 1	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1	Between 4 hours and 6 hours after drug administration on Day 1	No
Secondary	FVC AUC4-6 at Day 29	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29	Between 4 hours and 6 hours after drug administration on Day 29	No
Secondary	FVC AUC4-6 at Day 57	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57	Between 4 hours and 6 hours after drug administration on Day 57	No
Secondary	FVC AUC4-6 at Day 85	Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85	Between 4 hours and 6 hours after drug administration on Day 85	No
Secondary	Peak FVC Response at Day 1	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1	Within the first 2-hour post-treatment interval at Day 1	No
Secondary	Peak FVC Response at Day 29	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29	Within the first 2-hour post-treatment interval at Day 29	No
Secondary	Peak FVC Response at Day 57	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57	Within the first 2-hour post-treatment interval at Day 57	No
Secondary	Peak FVC Response at Day 85	Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85	Within the first 2-hour post-treatment interval at Day 85	No
Secondary	Rescue Medication Use on Pulmonary Test Day 1	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1	During the 6-hour pulmonary function testing after drug administration on Day 1	No
Secondary	Rescue Medication Use on Pulmonary Test Day 29	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29	During the 6-hour pulmonary function testing after drug administration on Day 29	No
Secondary	Rescue Medication Use on Pulmonary Test Day 57	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57	During the 6-hour pulmonary function testing after drug administration on Day 57	No
Secondary	Rescue Medication Use on Pulmonary Test Day 85	Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85	During the 6-hour pulmonary function testing after drug administration on Day 85	No
Secondary	Night-time Rescue Medication Use	The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)	During the 2-week baseline washout period and the 12-week treatment period	No
Secondary	Daytime Rescue Medication Use	The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)	During the 2-week baseline washout period and the 12-week treatment period	No
Secondary	Night-time Symptom Score	The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period).; Night-time COPD symptoms: 0=none 1=some - slept well 2=woke once 3=woke several times 4=woke most of night	During the 2-week baseline washout period and the 12-week treatment period	No
Secondary	Daytime Symptom Score	The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period).; Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities	During the 2-week baseline washout period and the 12-week treatment period	No
Secondary	Trough Peak Expiratory Flow Rate (PEFR)	The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)	During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication	No
Secondary	Physician's Global Evaluation Score on Pulmonary Function Testing Day 29	Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.; Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.	Prior to pulmonary function test on Day 29	No
Secondary	Physician's Global Evaluation Score on Pulmonary Function Testing Day 57	Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.; Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.	Prior to pulmonary function test on Day 57	No
Secondary	Physician's Global Evaluation Score on Pulmonary Function Testing Day 85	Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.; Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.	Prior to pulmonary function test on Day 85	No
Secondary	Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period	COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.	During the 12-week on-treatment period	No
Secondary	COPD Exacerbation Rate During the On-treatment Period	Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.	During the 12-week on-treatment period	No
Secondary	COPD Exacerbation During the On-treatment Period	COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.	During the 12-week on-treatment period	No
Secondary	Frequency Distribution of Satisfaction Rating With Inhaler Attributes		12 weeks	No
Secondary	Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine	Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.	12 weeks	No
Secondary	Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung	Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.	12 weeks	No
Secondary	Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left	Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.	12 weeks	No
Secondary	Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably	Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.	12 weeks	No
Secondary	Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler	Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.	12 weeks	No
Secondary	Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use	Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.	12 weeks	No
Secondary	Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable	Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.	12 weeks	No
Secondary	Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler	Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.	12 weeks	No
Secondary	Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler	Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.	12 weeks	No
Secondary	Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler	Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.	12 weeks	No
Secondary	Device Preference (Respimat or MDI)	Frequency of patients due to device preference	12 weeks	No
Secondary	Rating of Action of Turning Clear Base of Respimat	Frequency of patients due to rating of action of turning clear base of Respimat	12 weeks	No
Secondary	Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State	Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCt). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).	Before drug administration to 6 hours after drug administration on Day 29	No
Secondary	Noncompartmental Parameters of Albuterol at Steady State	Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCt). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).	Before drug administration to 6 hours after drug administration on Day 29	No
Secondary	Cumulative Amounts of Ipratropium [µg] Excreted in Urine for 0-2 Hours	Cumulative amounts of Ipratropium [µg] excreted in urine - Planned time intervals 0-2, ss	Before drug administration to 2 hours after drug administration on Day 29	No
Secondary	Cumulative Amounts of Albuterol [µg] Excreted in Urine for 0-2 Hours	Cumulative amounts of Albuterol [µg] excreted in urine - Planned time intervals 0-2,ss.	Before drug administration to 2 hours after drug administration on Day 29	No
Secondary	Cumulative Amounts of Ipratropium [µg] Excreted in Urine for 0-6 Hours	Cumulative amounts of Ipratropium [µg] excreted in urine - Planned time intervals 0-6,ss	Before drug administration to 6 hours after drug administration on Day 26	No
Secondary	Cumulative Amounts of Albuterol [µg] Excreted in Urine for 0-6 Hours	Cumulative amounts of Albuterol [µg] excreted in urine - Planned time intervals 0-6, ss	Before drug administration to 6 hours after drug administration on Day 29	No

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