Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

COPD Clinical Trial

— BRIGHT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294787
• Other study ID #: CQVA149A2305
• Secondary ID: 2010-022721-14
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2011
• Last updated: March 19, 2013
• Start date: February 2011
• Est. completion date: November 2011

Study information

• Verified date: March 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Bunesinstitut fur Arzneimittel und Medizinprodukte AgenciaSpain: Espanola de medicamentos y productos sanitarios
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• indacaterol and glycopyrronium bromide (QVA149)

• placebo

• tiotropium

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Grosshansdorf
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Lubeck
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Rudersdorf
Germany	Novartis Investigative Site	Wiesbaden
Spain	Novartis Investigative Site	Alicante
Spain	Novartis Investigative Site	Badalona
Spain	Novartis Investigative Site	Barakaldo
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Tolerance Comparison Between QVA149 and Placebo Groups	The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured by exercise endurance time (in seconds) during a sub-maximal constant load cycle ergometry test ((SMETT)which is a cycle exercise test) after three weeks of treatment.	3 weeks	No
Secondary	Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups	The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity at isotime during sub-maximal constant load cycle ergometry test ((SMETT)a cycle exercise test), after three weeks of treatment.	3 weeks	No
Secondary	Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups	The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose inspiratory capacity after three weeks of treatment.	3 weeks	No
Secondary	Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups	The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose Forced Expiratory Volume in one second (FEV1) after three weeks of treatment.	3 weeks	No
Secondary	Pulmonary Function Test Comparison Between QVA149 and Placebo Groups	The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Slow Vital Capacity (SVC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.	day 1 and day 21	No
Secondary	Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups	The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Residual Volume (RV) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.	day 1 and day 21	No
Secondary	Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups	The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Specific Airway Conductance (SGaw) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.	day 1 and day 21	No
Secondary	Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups	The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Functional Residual Capacity (FRC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.	day 1 and day 21	No
Secondary	Spirometry After Three Weeks of Treatment on Patients Not Exercising	The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity post-dose pre-exercise after three weeks of treatment.	3 weeks	No
Secondary	Exertional Dyspnea Comparison Between QVA149 and Placebo Groups	The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using exertional dyspnea Borg CR10 Scale® (After 3 weeks of treatment, before, during and after exercise, patients were asked to rate the intensity of their breathing and leg discomfort using the Borg CR10 Scale®). This scale consists of 12-point score that the participants pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).; A reduction in this score indicates an improvement.	3 weeks	No
Secondary	Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups	The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo on leg discomfort was measured using Borg CR10 Scale® during sub-maximal constant load cycle ergometry test after three weeks treatment.	3 weeks	No
Secondary	Exercise Endurance Comparison Between QVA149 and Tiotropium Groups	Effect of QVA149 110/50 µg o.d. compared with tiotropium 18 µg o.d. in patients with moderate to severe COPD with respect to exercise endurance was measured by a sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test) after three weeks of treatment.	3 weeks	No
Secondary	Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo	The effect of a single dose of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured with respect to exercise endurance time during sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test).	Day 1	No