COPDPhase 3BRIGHTNCT01294787

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

A Phase 3 study testing indacaterol and glycopyrronium bromide (QVA149) and tiotropium in people with COPD, run by Novartis Pharmaceuticals at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: indacaterol and glycopyrronium bromide (QVA149) and tiotropium
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 85 participants
Where: 13 sitesin 2 countries
Study dates: Feb 2011to Nov 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

13 sites in 2 countries.

Country

City, postcode or hospital

13 sites in 2 countries

Germany7 sites

Novartis Investigative Site
Frankfurt
Novartis Investigative Site
Großhansdorf
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Lübeck
Novartis Investigative Site
Mainz
Novartis Investigative Site
Rüdersdorf
Novartis Investigative Site
Wiesbaden

Other trials in Germany

Spain6 sites

Novartis Investigative Site
Alicante
Novartis Investigative Site
Badalona
Novartis Investigative Site
Barakaldo
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Madrid
Novartis Investigative Site
Málaga

Other trials in Spain

About this study

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.

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).

Conditions: COPD
Being tested: indacaterol and glycopyrronium bromide (QVA149), placebo, tiotropium
Keywords: COPD, QVA149, tiotropium, exercise, exercise tolerance, combination bronchodilator, moderate to severe COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

indacaterol and glycopyrronium bromide (QVA149)Drug
placeboDrug
tiotropiumDrug

Study groups in NCT01294787
Study group	Role	What they receive
indacaterol and glycopyrronium bromide (QVA149)	Experimental	QVA149 delivered once daily via single-dose dry powder inhaler. Receives: Drug: indacaterol and glycopyrronium bromide (QVA149)
placebo	Placebo comparator	Placebo, delivered once daily via single-dose dry powder inhaler. Receives: Drug: placebo
tiotropium	Active comparator	Tiotropium delivered once daily via HandiHaler® device. Receives: Drug: tiotropium

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 weeks

Secondary outcomes (12)

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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: day 1 and day 21
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.
Measured: day 1 and day 21
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.
Measured: day 1 and day 21
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.
Measured: day 1 and day 21
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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).
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Nov 2011

First posted11 Feb 2011 (estimated)
Study startFeb 2011
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01294787
Sponsor's protocol ID: CQVA149A2305
Other IDs: 2010-022721-14
Acronym: BRIGHT
Status last verified: Mar 2013
First submitted: 10 Feb 2011
Last updated: 20 Mar 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 24534204

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01294787
Acronym / sponsor ID: BRIGHT / CQVA149A2305
Conditions: COPD
Keywords: COPD, QVA149, tiotropium, exercise, exercise tolerance, combination bronchodilator, moderate to severe COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 11 Feb 2011 (estimated)
Results: Posted 20 Mar 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
indacaterol and glycopyrronium bromide (QVA149)	Experimental	Drug: indacaterol and glycopyrronium bromide (QVA149)QVA149 delivered once daily via single-dose dry powder inhaler.
placebo	Placebo comparator	Drug: placeboPlacebo, delivered once daily via single-dose dry powder inhaler.
tiotropium	Active comparator	Drug: tiotropiumTiotropium delivered once daily via HandiHaler® device.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
indacaterol and glycopyrronium bromide (QVA149)	Drug	indacaterol and glycopyrronium bromide (QVA149)
placebo	Drug	placebo
tiotropium	Drug	tiotropium

Primary outcome

Exercise Tolerance Comparison Between QVA149 and Placebo Groups
Time frame: 3 weeks
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.

12 secondary outcomes

Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups
Time frame: 3 weeks
Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups
Time frame: 3 weeks
Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups
Time frame: 3 weeks
Pulmonary Function Test Comparison Between QVA149 and Placebo Groups
Time frame: day 1 and day 21
Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups
Time frame: day 1 and day 21
Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups
Time frame: day 1 and day 21
Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups
Time frame: day 1 and day 21
Spirometry After Three Weeks of Treatment on Patients Not Exercising
Time frame: 3 weeks
Exertional Dyspnea Comparison Between QVA149 and Placebo Groups
Time frame: 3 weeks
Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups
Time frame: 3 weeks
Exercise Endurance Comparison Between QVA149 and Tiotropium Groups
Time frame: 3 weeks
Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo
Time frame: Day 1

Results and safety

Results posted to the registry on 20 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QVA149 / Placebo / Tiotropium	12	12
QVA149 / Tiotropium / Placebo	16	16
Placebo / QVA149 / Tiotropium	14	13
Placebo / Tiotropium / QVA149	12	11
Tiotropium / QAV149 / Placebo	16	14
Tiotropium / Placebo / QVA149	15	13

Primary outcome: Exercise Tolerance Comparison Between QVA149 and Placebo Groups

Time frame: 3 weeks. Least squares mean (Standard Error). Unit: Seconds

Measure	QVA149 n = 77	Placebo n = 74
Value	507.8 (19.30)	448.3 (19.49)

Population analysed: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indacaterol and Glycopyrronium Bromide (QVA149)	1 of 77 (1.3%)	11 of 77 (14.3%)	Not reported
Tiotropium	1 of 83 (1.2%)	5 of 83 (6%)	Not reported
Placebo	1 of 77 (1.3%)	4 of 77 (5.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24534204Beeh 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.

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

13 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing indacaterol and glycopyrronium bromide (QVA149) and tiotropium in people with COPD, run by Novartis Pharmaceuticals at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise Tolerance Comparison Between QVA149 and Placebo Groups (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01294787, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.