QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782326
• Other study ID #: CQVA149A2318
• Status: Completed
• Phase: Phase 3
• First received: January 30, 2013
• Last updated: March 29, 2016
• Start date: July 2013
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3362
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent must be obtained before any assessment is performed

• Male or female adults aged =40 years

• Patients with stable Chronic Obstructive Pulmonary Disease ( COPD) according to the current GOLD strategy (GOLD 2011)

• Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)

• Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) =25 and < 60% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 0.70 at day -28. (Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol)

• A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics

• Patients taking stable COPD medication (at least 60 days) prior to day 28

• Patients with an mMRC grade of at least 2 at day 28

Exclusion Criteria:

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential

• Patients with Type I or uncontrolled Type II diabetes

• Patients with a history of long QT syndrome or whose QTc measured at day 28 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened

• Patients who have a clinically significant ECG abnormality prior to randomization. (These patients should not be re-screened)

• Patients who have a clinically significant laboratory abnormality at screening

• Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment

• Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded

• Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at both pre-randomization visits, with a resting ventricular rate < 100/min. At screening the atrial fibrillation must be confirmed by central reading

• Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines, lactose or any of the other excipients of trial medication

• Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin

• Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. Benign Prostatic Hyperplasia (BPH) patients who are stable on treatment can be considered

• Patients who have not achieved an acceptable spirometry results at screening in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria)

• Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to screening

• Patients who develop a COPD exacerbation of any severity (mild/moderate/severe) between screening and treatment will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation

• Patients who have had a respiratory tract infection within 4 weeks prior to screening

• Patients who develop a respiratory tract infection between screening and prior to treatment will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection

• Patients requiring long term oxygen therapy prescribed for >12 hours per day

• Patients with any history of asthma

• Patients with an onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years

• Patients with a blood eosinophil count > 600/mm3 at screening

• Patients with allergic rhinitis who use a H1 antagonist or intra-nasal corticosteroids intermittently (treatment with a stable dose or regimen is permitted)

• Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension)

• Patients with clinically significant bronchiectasis

• Patients with a diagnosis of a-1 anti-trypsin deficiency

• Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active

• Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation

• Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study. (Maintenance program is permitted.)

• Patients receiving any medications in the classes listed in the protocol

• Patients receiving any COPD related medications in the classes specified in the protocol must undergo the required washout period prior to screening and follow the adjustment to treatment program

• Use of other investigational drugs/devices (approved or unapproved) at the time of enrollment, or within 30 days or 5 half-lives of screening, whichever is longer

• Patients unable to use an electronic patient diary and EXACT pro diary

• Patients unable to use a dry powder inhaler device, Metered Dose Inhaler (MDI) or a pressurized MDI (rescue medication) or comply with the study regimen.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI.
• Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires	Capital Federal
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad de Buenos Aires
Argentina	Novartis Investigative Site	Concepcion del Uruguay	Entre Ríos
Argentina	Novartis Investigative Site	Lanus	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Salta
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	Santa Fe
Austria	Novartis Investigative Site	Feldbach
Austria	Novartis Investigative Site	Feldkirch
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Grieskirchen
Austria	Novartis Investigative Site	Innsbruck	Tyrol
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Thalheim bei Wels
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigative Site	Wels
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Brussel
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Erpent
Belgium	Novartis Investigative Site	Genk	Limburg
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Gilly
Belgium	Novartis Investigative Site	Gosselies	BEL
Belgium	Novartis Investigative Site	Hasselt
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Liège
Belgium	Novartis Investigative Site	Luxembourg
Belgium	Novartis Investigative Site	Oostende
Belgium	Novartis Investigative Site	Roeselare
Belgium	Novartis Investigative Site	Turnhout
Belgium	Novartis Investigative Site	Wavre
Bulgaria	Novartis Investigative Site	Gabrovo
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Ruse
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Bulgaria	Novartis Investigative Site	Stara Zagora
Bulgaria	Novartis Investigative Site	Troyan
Bulgaria	Novartis Investigative Site	Varna
Canada	Novartis Investigative Site	Burlington	Ontario
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Canada	Novartis Investigative Site	Mirabel	Quebec
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Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	St-Charles-Borromée	Quebec
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Canada	Novartis Investigative Site	Vancouver	British Columbia
Chile	Novartis Investigative Site	Quillota
Chile	Novartis Investigative Site	Santiago
Chile	Novartis Investigative Site	Santiago
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changsha	Hunan
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China	Novartis Investigative Site	Chongqing
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Colombia	Novartis Investigative Site	Medellín
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Croatia	Novartis Investigative Site	Zagreb
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Czech Republic	Novartis Investigative Site	Praha 6 - Repy
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Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
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Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freudenberg
Germany	Novartis Investigative Site	Gauting
Germany	Novartis Investigative Site	Geesthacht	Schleswig Holstein
Germany	Novartis Investigative Site	Hagen
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Hannover Münden
Germany	Novartis Investigative Site	Heidelberg	Baden-Württemberg
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Koblenz	NRW
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Landsberg
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lübeck
Germany	Novartis Investigative Site	Lübeck
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Minden
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Neu Isenburg
Germany	Novartis Investigative Site	Neumünster
Germany	Novartis Investigative Site	Oranienburg
Germany	Novartis Investigative Site	Peine	Niedersachsen
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Prien a. Chiemsee
Germany	Novartis Investigative Site	Ratingen
Germany	Novartis Investigative Site	Reinfeld
Germany	Novartis Investigative Site	Rüdersdorf
Germany	Novartis Investigative Site	Schleswig
Germany	Novartis Investigative Site	Schwabach
Germany	Novartis Investigative Site	Solingen
Germany	Novartis Investigative Site	Stade
Germany	Novartis Investigative Site	Teuchern
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Warendorf
Germany	Novartis Investigative Site	Weinheim
Germany	Novartis Investigative Site	Wissen
Germany	Novartis Investigative Site	Witten
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Heraklion Crete
Greece	Novartis Investigative Site	Larissa	GR
Greece	Novartis Investigative Site	Rethymno	GR
Greece	Novartis Investigative Site	Serres
Greece	Novartis Investigative Site	Thessaloniki
Greece	Novartis Investigative Site	Thessaloniki	GR
Guatemala	Novartis Investigative Site	Ciudad	Gautemala
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Hong Kong	Novartis Investigative Site	Kowloon
Hong Kong	Novartis Investigative Site	New Territories
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Deszk
Hungary	Novartis Investigative Site	Komarom
Hungary	Novartis Investigative Site	Torokbalint
Iceland	Novartis Investigative Site	Reykjavik
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Bangalore
India	Novartis Investigative Site	Chennai	Tamil Nadu
India	Novartis Investigative Site	Coimbatore	Tamil Nadu
India	Novartis Investigative Site	Coimbatore	Tamil Nadu
India	Novartis Investigative Site	Coimbatore	Tamilnadu
India	Novartis Investigative Site	Gurgaon	Haryana
India	Novartis Investigative Site	Hyderabad	Andhra Pradesh
India	Novartis Investigative Site	Kolkata	West Bengal
India	Novartis Investigative Site	Ludhiana	Punjab
India	Novartis Investigative Site	Manipal	Karnataka
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Vijayawada	Andhra Pradesh
India	Novartis Investigative Site	Visakhapatnam	Andhra Pradesh
Italy	Novartis Investigative Site	Ancona	AN
Italy	Novartis Investigative Site	Cassano delle Murge	BA
Italy	Novartis Investigative Site	Cittadella	PD
Italy	Novartis Investigative Site	Crema	CR
Italy	Novartis Investigative Site	Cuasso al Monte	VA
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Foggia	FG
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Negrar	VR
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Pavia	PV
Italy	Novartis Investigative Site	Pavullo nel Frignano	MO
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Pordenone	PN
Italy	Novartis Investigative Site	Reggio Emilia	RE
Italy	Novartis Investigative Site	Tradate	VA
Japan	Novartis Investigative Site	Asahikawa-city	Hokkaido
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Hamamatsu	Shizuoka
Japan	Novartis Investigative Site	Hamamatsu	Shizuoka
Japan	Novartis Investigative Site	Himeji-city	Hyogo
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Iwata	Shizuoka
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kishiwada-city	Osaka
Japan	Novartis Investigative Site	Kiyose-city	Tokyo
Japan	Novartis Investigative Site	Kochi
Japan	Novartis Investigative Site	Komaki-city	Aichi
Japan	Novartis Investigative Site	Koshi-city	Kumamoto
Japan	Novartis Investigative Site	Koshigaya-city	Saitama
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Matsusaka-city	Mie
Japan	Novartis Investigative Site	Meguro	Tokyo
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Sakaide-city	Kagawa
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sendai-city	Miyagi
Japan	Novartis Investigative Site	Seto-city	Aichi
Japan	Novartis Investigative Site	Takamatsu	Kagawa
Japan	Novartis Investigative Site	Toyoake-city	Aichi
Japan	Novartis Investigative Site	Yanagawa-city	Fukuoka
Korea, Republic of	Novartis Investigative Site	Bucheon-Si	Gyeonggi-Do
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Jeonju-si	Jeollabuk-do
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Latvia	Novartis Investigative Site	Daugavpils
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga	LV
Lithuania	Novartis Investigative Site	Alytus
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Kaunas	LT
Lithuania	Novartis Investigative Site	Klaipeda
Lithuania	Novartis Investigative Site	Klaipeda
Lithuania	Novartis Investigative Site	Vilnius
Lithuania	Novartis Investigative Site	Vilnius
Lithuania	Novartis Investigative Site	Vilnius	LT
Mexico	Novartis Investigative Site	Aguascalientes
Mexico	Novartis Investigative Site	Guadalajara Jalisco	Jalisco
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Mexico	Novartis Investigative Site	México	Distrito Federal
Mexico	Novartis Investigative Site	Mexico D.F.
Mexico	Novartis Investigative Site	Puebla
Mexico	Novartis Investigative Site	Zapopan	Jalisco
Netherlands	Novartis Investigative Site	Almelo
Netherlands	Novartis Investigative Site	Assen
Netherlands	Novartis Investigative Site	Breda
Netherlands	Novartis Investigative Site	Eindhoven
Netherlands	Novartis Investigative Site	Enschede
Netherlands	Novartis Investigative Site	Geldrop
Netherlands	Novartis Investigative Site	Groningen
Netherlands	Novartis Investigative Site	Harderwijk
Netherlands	Novartis Investigative Site	Zutphen
Norway	Novartis Investigative Site	Follebu
Norway	Novartis Investigative Site	Hønefoss
Norway	Novartis Investigative Site	Kløfta
Norway	Novartis Investigative Site	Kongsvinger
Norway	Novartis Investigative Site	Skedsmokorset
Norway	Novartis Investigative Site	Stavanger
Norway	Novartis Investigative Site	Svelvik
Norway	Novartis Investigative Site	Trondheim
Philippines	Novartis Investigative Site	Bulacan
Philippines	Novartis Investigative Site	Lipa City	Batangas
Philippines	Novartis Investigative Site	Quezon City
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Pila
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Sopot
Poland	Novartis Investigative Site	Wroclaw
Portugal	Novartis Investigative Site	Almada
Portugal	Novartis Investigative Site	Barcelos
Portugal	Novartis Investigative Site	Braga
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
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Portugal	Novartis Investigative Site	Vila Franca de Xira
Portugal	Novartis Investigative Site	Vila Nova de Gaia
Portugal	Novartis Investigative Site	Viseu
Romania	Novartis Investigative Site	Arad
Romania	Novartis Investigative Site	Arad
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest	District 3
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Bucuresti	District 1
Romania	Novartis Investigative Site	Cluj-Napoca
Romania	Novartis Investigative Site	Craiova	Dolj
Romania	Novartis Investigative Site	Deva
Romania	Novartis Investigative Site	Deva
Romania	Novartis Investigative Site	Iasi
Romania	Novartis Investigative Site	Iasi	Jud. Iasi
Romania	Novartis Investigative Site	Oradea
Romania	Novartis Investigative Site	Targu Mures
Romania	Novartis Investigative Site	Timisoara	Timis
Russian Federation	Novartis Investigative Site	Barnaul
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	N.Novgorod
Russian Federation	Novartis Investigative Site	Rostov-on-Don
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Tver
Russian Federation	Novartis Investigative Site	Ufa
Russian Federation	Novartis Investigative Site	Yaroslavl
Serbia	Novartis Investigative Site	Belgrade
Serbia	Novartis Investigative Site	Belgrade
Serbia	Novartis Investigative Site	Knez Selo
Serbia	Novartis Investigative Site	Kragujevac
Slovakia	Novartis Investigative Site	Bardejov	Slovak Republic
Slovakia	Novartis Investigative Site	Bojnice	Slovak Republic
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Humenné	Slovak republic
Slovakia	Novartis Investigative Site	Kosice	Slovak republic
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Liptovsky Hradok	Slovak Republic
Slovakia	Novartis Investigative Site	Lucenec
Slovakia	Novartis Investigative Site	Martin
Slovakia	Novartis Investigative Site	Námestovo	Slovensko
Slovakia	Novartis Investigative Site	Nove Zamky
Slovakia	Novartis Investigative Site	Partizanske	Slovak Republic
Slovakia	Novartis Investigative Site	Poprad
Slovakia	Novartis Investigative Site	Povazska Bystrica
Slovakia	Novartis Investigative Site	Spisská Nová Ves
South Africa	Novartis Investigative Site	Berea	Durban
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Gatesville
South Africa	Novartis Investigative Site	Port Elizabeth
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Sandton	Gauteng
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Alzira	Comunidad Valenciana
Spain	Novartis Investigative Site	Baracaldo	Vizcaya
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Burgos	Castilla y Leon
Spain	Novartis Investigative Site	Cartagena	Murcia
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Merida	Extremadura
Spain	Novartis Investigative Site	Oviedo	Asturias
Spain	Novartis Investigative Site	Ponferrada	Castilla y Leon
Spain	Novartis Investigative Site	Pozuelo de Alarcón	Madrid
Spain	Novartis Investigative Site	Salt	Cataluña
Spain	Novartis Investigative Site	Sanlucar de Barrameda	Andalucia
Spain	Novartis Investigative Site	Torrelavega	Cantabria
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valladolid	Castilla y Leon
Sweden	Novartis Investigative Site	Boras
Sweden	Novartis Investigative Site	Luleå
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Trollhattan
Sweden	Novartis Investigative Site	Uddevalla
Taiwan	Novartis Investigative Site	Chiayi County
Taiwan	Novartis Investigative Site	Niaosong Township
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Tainan 704	Taiwan ROC
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei County
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Thailand	Novartis Investigative Site	Khon Kaen
Thailand	Novartis Investigative Site	Songkla
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Kinikli / Denizli
Turkey	Novartis Investigative Site	Manisa
Turkey	Novartis Investigative Site	Mersin
United Kingdom	Novartis Investigative Site	Axbridge	Somerset
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	Cambridge
United Kingdom	Novartis Investigative Site	Chester
United Kingdom	Novartis Investigative Site	Crawley	West Sussex
United Kingdom	Novartis Investigative Site	Darlington
United Kingdom	Novartis Investigative Site	Huntingdon	Cambridgeshire
United Kingdom	Novartis Investigative Site	Lancashire
United Kingdom	Novartis Investigative Site	Leeds
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Midsomer Norton	Radstock
United Kingdom	Novartis Investigative Site	Newcastle-upon-Tyne
United Kingdom	Novartis Investigative Site	South Shields	Tyne and Wear
United Kingdom	Novartis Investigative Site	Southampton
United Kingdom	Novartis Investigative Site	Stockton	Cleveland
United Kingdom	Novartis Investigative Site	Taunton	Somerset
United Kingdom	Novartis Investigative Site	Tyne & Wear
United Kingdom	Novartis Investigative Site	Wiltshire

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czech Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Guatemala,  Hong Kong,  Hungary,  Iceland,  India,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Norway,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of COPD exacerbations	The rate of COPD exacerbations over 52 weeks of treatment.	52 weeks	No
Secondary	Time to first COPD exacerbation.	The time to the first COPD exacerbation over 52 weeks of treatment.	52 weeks	No
Secondary	Rate of moderate to severe COPD exacerbations.	The rate of moderate to severe COPD exacerbations during 52 weeks of treatment.	52 weeks	No
Secondary	Time to first moderate to severe COPD exacerbation.	The time to the first moderate to severe COPD exacerbation over 52 weeks of treatment.	52 weeks.	No
Secondary	Rate of moderate to severe COPD exacerbations requiring treatment with systemic corticosteroids	The rate of moderate to severe COPD exacerbations requiring treatment with systemic corticosteroids over 52 weeks of treatment.	52 weeks	No
Secondary	Rate of moderate to severe COPD exacerbations requiring treatment with antibiotics	The rate of moderate to severe COPD exacerbations requiring treatment with antibiotics during 52 weeks of treatment.	52 weeks	No
Secondary	Rate of moderate to severe COPD exacerbations requiring hospitalization.	The rate of moderate to severe COPD exacerbations requiring hospitalization during 52 weeks of treatment.	52 weeks	No
Secondary	Rate of moderate to severe COPD exacerbations requiring re-hospitalization within 30 days	The rate of moderate to severe COPD exacerbations requiring re-hospitalization within 30 days, during the 52 week treatment period.	52 weeks	No
Secondary	Time to first moderate to severe COPD exacerbations requiring treatment with systemic corticosteroids	The time to first moderate to severe COPD exacerbation requiring treatment with systemic corticosteroids during 52 week of treatment.	52 weeks	No
Secondary	Time to first moderate to severe COPD exacerbations requiring treatment with antibiotics	Time to first COPD exacerbation requiring treatment with antibiotics during 52 weeks of treatment.	52 weeks	No
Secondary	Time to first moderate to severe COPD exacerbations requiring hospitalization	Time to first moderate to severe COPD exacerbation requiring hospitalization during 52 weeks of treatment.	52 weeks	No
Secondary	Time to first moderate to severe COPD exacerbations requiring re-hospitalization within 30 days	Time to first moderate to severe COPD exacerbation requiring re-hospitalization within 30 days, during 52 weeks of treatment.	52 weeks	No
Secondary	Forced expiratory volume in 1 second	Forced expiratory volume in 1 second on day 1 of treatment.	1 day	No
Secondary	Forced expiratory volume in 1 second	Pre-dose forced expiratory volume in 1 second following 4 weeks of treatment.	4 weeks	No
Secondary	Forced expiratory volume in 1 second	Pre-dose trough forced expiratory volume in 1 second following 12 weeks of treatment.	12 weeks	No
Secondary	Forced expiratory volume in 1 second	Pre-dose trough Forced expiratory volume in 1 second following 26 weeks of treatment.	26 weeks	No
Secondary	Forced expiratory volume in 1 second	Pre-dose trough Forced expiratory volume in 1 second following 38 weeks of treatment.	38 weeks	No
Secondary	Forced expiratory volume in 1 second	Pre-dose trough Forced expiratory volume in 1 second following 52 weeks of treatment.	52 weeks	No
Secondary	Forced expiratory volume in 1 second AUC (0-12h)	Forced expiratory volume in 1 second Area Under the Curve (0-12 hours) following 52 weeks of treatment.	52 weeks	No
Secondary	Total St. George's Respiratory Questionnaire score	Change in health status as reported by patients using the St. George's Respiratory Questionnaire (SGRQ-C), following 4 weeks of treatment.	4 weeks	No
Secondary	Total St. George's Respiratory Questionnaire score	Change in health status as reported by patients using the St. George's Respiratory Questionnaire (SGRQ-C), following 12 weeks of treatment.	12 weeks	No
Secondary	Total St. George's Respiratory Questionnaire score	Change in health status as reported by patients using the St. George's Respiratory Questionnaire (SGRQ-C), following 26 weeks of treatment.	26 weeks	No
Secondary	Total St. George's Respiratory Questionnaire score	Change in health status as reported by patients using the St. George's Respiratory Questionnaire (SGRQ-C), following 38 weeks of treatment.	38 weeks	No
Secondary	Total St. George's Respiratory Questionnaire score	Change in health status as reported by patients using the St. George's Respiratory Questionnaire (SGRQ-C), following 52 weeks of treatment.	52 weeks	No
Secondary	Number of puffs of rescue medication	Rescue medication use (number of puffs) reported by the patients using patient electronic diary following 52 weeks of treatment.	52 weeks	No
Secondary	Safety of QVA149 ((110/50 µg o.d.) vs fluticasone/salmeterol (500/50µg bid) in terms of HPA axis function, as determined by collection of 24-hour urine cortisol.	Urine is collected over 24 hours through 52 weeks.	52 Weeks	Yes
Secondary	Change From Baseline in Forced Vital Capacity	Forced vital capacity is the total amount of air exhaled during forced spirometry test. Baseline Forced Vital Capacity was defined as the average of the pre-dose FVC at Day 1.	BL, Day 1, Week 4, Week 12, Week 26, Week 38, Week 52	No
Secondary	Safety (particularly in regards to adverse events, laboratory test, vitals, and ECGs) of QVA149 (110/50 µg o.d.) vs fluticasone/salmeterol (500/50µg bid) over 52 weeks of treatment.	Overall safety in regards to adverse events, laboratory tests (hematology, clinical chemistry, and urinalysis), vitals, and ECGs collected over 52 weeks of treatment.	52 weeks	Yes