Clinical trial NCT01294787: Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Blinded, Double Dummy, Multi-center, Placebo Controlled, 3 Period, Crossover Study to Assess the Effect of QVA149 (110/50 µg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Keywords: COPD
QVA149
tiotropium
exercise
exercise tolerance
combination bronchodilator
moderate to severe COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 85
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149) on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) stage II or stage III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2009)
* Qualifying spirometry, Forced Expiratory Volume in one second (FEV1) and post-bronchodilator FEV1/FVC (Forced Vital capacity)
* Smoking history ≥ 10 pack years

Exclusion Criteria:

* Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
* Cardiac abnormality
* History of asthma
* Contraindications to cardiopulmonary exercise testing
* Participation in active phase of pulmonary rehabilitation program
* History of cancer within the past 5 years

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Exercise Tolerance Comparison Between QVA149 and Placebo Groups
timeFrame: 3 weeks
Secondary outcomes:
measure: Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups
timeFrame: 3 weeks
measure: Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups
timeFrame: 3 weeks
measure: Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups
timeFrame: 3 weeks
measure: Pulmonary Function Test Comparison Between QVA149 and Placebo Groups
timeFrame: day 1 and day 21
measure: Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups
timeFrame: day 1 and day 21
measure: Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups
timeFrame: day 1 and day 21
measure: Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups
timeFrame: day 1 and day 21
measure: Spirometry After Three Weeks of Treatment on Patients Not Exercising
timeFrame: 3 weeks
measure: Exertional Dyspnea Comparison Between QVA149 and Placebo Groups
timeFrame: 3 weeks
measure: Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups
timeFrame: 3 weeks
measure: Exercise Endurance Comparison Between QVA149 and Tiotropium Groups
timeFrame: 3 weeks
measure: Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo
timeFrame: Day 1
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Grosshansdorf
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Lubeck
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Rudersdorf
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Alicante
country: Spain
facility: Novartis Investigative Site
city: Badalona
country: Spain
facility: Novartis Investigative Site
city: Barakaldo
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Beeh KM, Korn S, Beier J, Jadayel D, Henley M, D'Andrea P, Banerji D. Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: the BRIGHT study. Respir Med. 2014 Apr;108(4):584-92. doi: 10.1016/j.rmed.2014.01.006. Epub 2014 Jan 21.