Clinical trial NCT01202188: A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official title: A 26-week Treatment Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled (Open Label) Study to Assess the Efficacy, Safety and Tolerability of QVA149 (110/50 μg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA149, COPD, combination bronchodilator, indacaterol, glycopyrronium bromide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 2144
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.


Eligibility criteria: Inclusion Criteria:

* Male or female adults aged ≥40 yrs
* Smoking history of at least 10 pack years
* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
* Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70%

Exclusion Criteria:

* Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular co-morbid conditions
* Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
* Patients in the active phase of a supervised pulmonary rehabilitation program
* Patients contraindicated for inhaled anticholinergic agents and β2 agonists
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment
timeFrame: 23 hours 15 minutes and 23 hour 45 minute post-dose Week 26
Secondary outcomes:
measure: Transitional Dyspnea Index (TDI) Focal Score at Week 26
timeFrame: Week 26
measure: St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 26
timeFrame: 26 weeks
measure: Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Over 26 Weeks
timeFrame: Baseline, Week 26
measure: Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149, QAB149 and NVA237 Compared to Placebo
timeFrame: 23 hours 15 minutes and 23 hour 45 minute post-dose Week 26
measure: Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149 Compared to Tiotropium
timeFrame: 23 hours 15 minutes and 23 hour 45 minute post-dose Week 26
measure: Baseline Transitional Dyspnea Index (BDI/TDI) Focal Score at Week 12 and Week 26
timeFrame: Baseline, Week 12, Week 26
measure: Percentage of Patients With a Clinically Important Improvement of at Least 1 Point in TDI Focal Score After 26 Weeks of Treatment
timeFrame: Baseline, Week 26
measure: St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 and 26 Weeks of Treatment
timeFrame: Week 12, Week 26
measure: Percentage of Patients With a Clinically Important Improvement From Baseline of at Least 4 Units in the SGRQ Total Score After 26 Weeks of Treatment
timeFrame: Baseline, Week 26
measure: Percentage of Nights With "No Night Time Awakenings" Over 26 Weeks
timeFrame: 26 Weeks
measure: Percentage of Days With "No Daytime Symptoms" Over 26 Weeks
timeFrame: 26 Weeks
measure: Percentage of "Days Able to Perform Usual Daily Activities" Over 26 Weeks
timeFrame: 26 Weeks
measure: Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication at Week 12 and Week 26
timeFrame: Baseline, Week 12, Week 26
measure: Change From Baseline (BL) in the Daytime and Night Time Rescue Medication Use (Number of Puffs) Over 26 Weeks
timeFrame: Baseline, Week 26
measure: Percentage of "Days With no Rescue Medication Use" Over 26 Weeks
timeFrame: 26 Weeks
measure: Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours at Day 1 and Week 26
timeFrame: From 5 minutes to 4 hours post-dose Day 1 and Week 26
measure: Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours at Day 1 and Week 26
timeFrame: From 5 minutes to 12 hours post-dose Day 1 and Week 26
measure: Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes at Week 26
timeFrame: From 5 minutes to 23 hours 45 minutes post-dose Week 26
measure: 24 Hour Holter Monitoring in a Subset of Patients
timeFrame: Week 12, Week 26
measure: Rate of Moderate or Severe COPD Exacerbation
timeFrame: 26 Weeks
measure: Percentage of Patients With at Least One Moderate or Severe COPD Exacerbation Over the 26 Week Treatment Period
timeFrame: 26 Weeks
measure: Percentage of Participants With COPD Exacerbations Requiring Hospitalization or Treatment With Systemic Corticosteroids and/or Antibiotics But no Hospitalization
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Novartis Investigative Site
state: California
city: Riverside
country: United States
facility: Novartis Investigative Site
state: California
city: St. Petersburg
country: United States
facility: Novartis Investigative Site
state: Florida
city: Troy
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: St. Charles
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Greenville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Johnson City
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Daw Park
country: Australia
facility: Novartis Investigative Site
city: Glebe
country: Australia
facility: Novartis Investigative Site
city: Kogarah
country: Australia
facility: Novartis Investigative Site
city: Nedlands
country: Australia
facility: Novartis Investigative Site
city: New lambton
country: Australia
facility: Novartis Investigative site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Russe
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Stara Zagora
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Burlington
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Courtice
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Mississuaga
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Beuvry
country: France
facility: Novartis Investigative Site
city: Bourges
country: France
facility: Novartis Investigative Site
city: Ferolles-Attily
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Erfurt
country: Germany
facility: Novartis Investigative Site
city: Geesthacht
country: Germany
facility: Novartis Investigative Site
city: Hanover
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Balassagyarmat
country: Hungary
facility: Novartis INvestigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
city: Komarom
country: Hungary
facility: Novartis Investigative Site
city: Nyiregyhaza
country: Hungary
facility: Novartis Investigative Site
city: Tatabanya
country: Hungary
facility: Novartis Investigative Site
city: Asahikawa
country: Japan
facility: Novartis Investigative Site
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Hachioji
country: Japan
facility: Novartis Investigative Site
city: Hamakita
country: Japan
facility: Novartis Investigative Site
city: Himeji
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hitachi
country: Japan
facility: Novartis Investigative Site
city: Itabashi
country: Japan
facility: Novartis Investigative Site
city: Iwata
country: Japan
facility: Novartis Inverstigative Site
city: Kamogawa
country: Japan
facility: Novartis Investigative Site
city: Kishiwada
country: Japan
facility: Novartis Investigative Site
city: Kiyose
country: Japan
facility: Novartis Investigative Site
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
city: Matsusaka
country: Japan
facility: Novartis Investigative Site
city: Matumoto
country: Japan
facility: Novartis Investigative Site
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
city: Moriya
country: Japan
facility: Novartis Investigative Site
city: Nagaoka
country: Japan
facility: Novartis Investigative Site
city: Nagoya
country: Japan
facility: Novartis Investigative Site
city: Niigata
country: Japan
facility: Novartis Investigative Site
city: Obihiro
country: Japan
facility: Novartis Investigative Site
city: Sakaide
country: Japan
facility: Novartis Investigative Site
city: Sakai
country: Japan
facility: Novartis Investigative Site
city: Sapporo
country: Japan
facility: Novartis Investigative Site
city: Tachikawa
country: Japan
facility: Novartis Investigative Site
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
city: Tsu
country: Japan
facility: Novartis Investigative Site
city: Yabu
country: Japan
facility: Novartis Investigative Site
city: Yanagawa
country: Japan
facility: Novartis Investigative Site
city: Yatsushiro
country: Japan
facility: Novartis Investigative Site
city: Yonezawa
country: Japan
facility: Novartis Investigative Site
city: Bulacan
country: Philippines
facility: Novartis Investigative Site
city: Las Pinas City
country: Philippines
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
city: Pasay City
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Proszowice
country: Poland
facility: Novartis Investigative Site
city: Tarnov
country: Poland
facility: Novartis Investigative Site
city: Warsaw
country: Poland
facility: Novartis Investigative Site
city: Barnaul
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhny Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhny Novogorod
country: Russian Federation
facility: Novartis Investigative Site
city: Samara
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ufa
country: Russian Federation
facility: Novartis Investigative Site
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
city: Bojnice
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Humenne
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Liptovsky Hradok
country: Slovakia
facility: Novartis Investigative Site
city: Partizanske
country: Slovakia
facility: Novartis Investigative Site
city: Prievidza
country: Slovakia
facility: Novartis Investigative Site
city: Spisska Nova Ves
country: Slovakia
facility: Novartis Investigative Site
city: Trstena
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
city: Zvolen
country: Slovakia
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
city: Johannesburg
country: South Africa
facility: Novartis Investigative Site
city: Lyttleton
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Alcira
country: Spain
facility: Novartis Investigative Site
city: Badalona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Canet de Mar
country: Spain
facility: Novartis Investigative Site
city: Centelles
country: Spain
facility: Novartis Investigative Site
city: Ferrol
country: Spain
facility: Novartis Investigative Site
city: Fuenlabrada
country: Spain
facility: Novartis Investigative Site
city: Les Borges del Camp
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Mataro
country: Spain
facility: Novartis Investigative Site
city: Merida
country: Spain
facility: Novartis Investigative Site
city: Mostoles
country: Spain
facility: Novartis Investigative Site
city: Motril
country: Spain
facility: Novartis Investigative Site
city: Palma de Mallorca
country: Spain
facility: Novartis Investigative Site
city: Ponferrada
country: Spain
facility: Novartis Investigative Site
city: Salamanca
country: Spain
facility: Novartis Investigative Site
city: Salt
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Vic
country: Spain
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Lugano
country: Switzerland
facility: Novartis Investigative Site
city: Munchenstein
country: Switzerland
facility: Novartis Investigative Site
city: Neuchatel
country: Switzerland
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
city: Chai-Yi
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Bolu
country: Turkey
facility: Novartis Investigative Site
city: Bursa
country: Turkey
facility: Novartis Investigative Site
city: Canakkale
country: Turkey
facility: Novartis Investigative Site
city: Denizli
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
city: Manisa
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Bath
country: United Kingdom
facility: Novartis Investigative Site
city: Blackpool
country: United Kingdom
facility: Novartis Investigative Site
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
city: Cambs
country: United Kingdom
facility: Novartis Investigative Site
city: Chelmsford
country: United Kingdom
facility: Novartis Investigative Site
city: Chesterfield
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Herts
country: United Kingdom
facility: Novartis Investigative Site
city: Isle of Wight
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Kulich K, Keininger DL, Tiplady B, Banerji D. Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study. Int J Chron Obstruct Pulmon Dis. 2015 Jan 7;10:79-94. doi: 10.2147/COPD.S73092. eCollection 2015.