Chronic Obstructive Pulmonary Disease (COPD)Phase 4REVERBREZNCT01272362

To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol

A Phase 4 study testing Indacaterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 137 sites in France.

Completed

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

Official record

Search all trials

Trial summary

In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Indacaterol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 625 participants
Where: 137 sitesFrance
Study dates: Apr 2010to May 2012
Phase: Phase 4
Are there results?: None posted in the registry

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 COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:
Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced vital capacity) <70%
Smoking history of at least 10 pack-years

Who cannot join

Patients who have had a COPD exacerbation in the 6 weeks prior to screening
Patients who have had a respiratory tract infection within 4 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

137 sites in 1 country.

City, postcode or hospital

137 sites in 1 country

France137 sites

Novartis Investigative Site
Abbeville, 80100
Novartis Investigative Site
Ajaccio, 20000
Novartis Investigative Site
Albi, 81000
Novartis Investigative Site
Albi, 81030
Novartis Investigative Site
Amboise, 37403
Novartis Investigative Site
Amiens, 80090
Novartis Investigative Site
Amiens, 80094
Novartis Investigative Site
Angers, 49033
Novartis Investigative Site
Angoulême, 16000
Novartis Investigative Site
Argenteuil, 95107
Novartis Investigative Site
Arles, 13200
Novartis Investigative Site
Arles, 13637
Novartis Investigative Site
Armentières, 59400
Novartis Investigative Site
Aubergenville, 78410
Novartis Investigative Site
Bastia, 20200
Novartis Investigative Site
Bastia, 20600
Novartis Investigative Site
Beauvais, 60021
Novartis Investigative Site
Bédarieux, 34600
Novartis Investigative Site
Belfort, 90000
Novartis Investigative Site
Bergerac, 24108
Novartis Investigative Site
Béziers, 34500
Novartis Investigative Site
Blois, 41000
Novartis Investigative Site
Bois-Guillaume, 76230
Novartis Investigative Site
Bordeaux, 33000
Novartis Investigative Site
Boulogne-Billancourt, 92104
Novartis Investigative Site
Briançon, 05105
Novartis Investigative Site
Briey, 54152
Novartis Investigative Site
Cambrai, 59400
Novartis Investigative Site
Castelnau-le-Lez, 34170
Novartis Investigative Site
Ceret, 66400
Novartis Investigative Site
Châteaubriant, 44146
Novartis Investigative Site
Châteauroux, 36000
Novartis Investigative Site
Châtellerault, 86106
Novartis Investigative Site
Chauny, 02300
Novartis Investigative Site
Chelles, 77500
Novartis Investigative Site
Cherbourg Octeville, 50102
Novartis Investigative Site
Cholet, 49325
Novartis Investigative Site
Cognac, 16108
Novartis Investigative Site
Colmar, 68000
Novartis Investigative Site
Compiègne, 60200
Novartis Investigative Site
Dieulefit, 26220
Novartis Investigative Site
Dijon, 21000
Novartis Investigative Site
Dijon, 21079
Novartis Investigative Site
Dole, 39100
Novartis Investigative Site
Écully
Novartis Investigative Site
Ermont, 95120
Novartis Investigative Site
Ferolles-Attily, France, 77150
Novartis Investigative Site
Forbach, 57600
Novartis Investigative Site
Grenoble, 38100
Novartis Investigative Site
Grenoble Cédex 9, 38043
Novartis Investigative Site
Hénin-Beaumont, 62110
Novartis Investigative Site
Herblay-sur-Seine, 95220
Novartis Investigative Site
Ismer, 38330
Novartis Investigative Site
Jean de Verges, 9000
Novartis Investigative Site
L'Aigle, 61305
Novartis Investigative Site
La Chausse Saint Victor, 41260
Novartis Investigative Site
La Garde, 83130
Novartis Investigative Site
La Teste-de-Buch, 32260
Novartis Investigative Site
La Teste-de-Buch, 33260
Novartis Investigative Site
Le Cannet, 06110
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275
Novartis Investigative Site
Le Mans, 72037
Novartis Investigative Site
Le Perreux-sur-Marne, 94170
Novartis Investigative Site
Lens, 62300
Novartis Investigative Site
Libourne, 33505
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Lille, 59800
Novartis Investigative Site
Limoges, 87042
Novartis Investigative Site
Lomme, 59462
Novartis Investigative Site
Lunel, 34400
Novartis Investigative Site
Lunéville, 54300
Novartis Investigative Site
Marseille, 13006
Novartis Investigative Site
Metz, 57038
Novartis Investigative Site
Molsheim, 67120
Novartis Investigative Site
Mont-de-Marsan, 40000
Novartis Investigative Site
Mont-Saint-Martin, 54350
Novartis Investigative Site
Montauban, 82017
Novartis Investigative Site
Montbéliard, 25200
Novartis Investigative Site
Montfermeil, 93370
Novartis Investigative Site
Montigny-lès-Metz, 57950
Novartis Investigative Site
Montpellier, 34070
Novartis Investigative Site
Mulhouse, 68070
Novartis Investigative Site
Mulhouse, 68100
Novartis Investigative Site
Nancy, 54100
Novartis Investigative Site
Nantes, 44000
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Narbonne, 11100
Novartis Investigative Site
Nevers, 58000
Novartis Investigative Site
Nice, 06000
Novartis Investigative Site
Nîmes, 30900
Novartis Investigative Site
Obernai, 67210
Novartis Investigative Site
Ollioules, 83192
Novartis Investigative Site
Paris, 75006
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75014
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Paris, 75651
Novartis Investigative Site
Péronne, 80201
Novartis Investigative Site
Perpignan, 66025
Novartis Investigative Site
Pierre-Bénite, 69495
Novartis Investigative Site
Poitiers, 86021
Novartis Investigative Site
Quimper, 29000
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Rennes, 35700
Novartis Investigative Site
Roubaix, 59100
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Royan, 17200
Novartis Investigative Site
Saint-Gaudens, 31806
Novartis Investigative Site
Saint-Quentin, 02100
Novartis Investigative Site
Saint-Quentin, 02321
Novartis Investigative Site
Sainte-Feyre, 23000
Novartis Investigative Site
Saintes, 17108
Novartis Investigative Site
Salon-de-Provence, 13300
Novartis Investigative Site
Sceaux, 92330
Novartis Investigative Site
Sélestat, 67600
Novartis Investigative Site
Soissons, 02200
Novartis Investigative Site
Strasbourg, 67000
Novartis Investigative Site
Strasbourg, 67100
Novartis Investigative Site
Suresnes, France, 92150
Novartis Investigative Site
Taden, 22100
Novartis Investigative Site
Thiais, 94320
Novartis Investigative Site
Thionville, 57100
Novartis Investigative Site
Thionville, 57126
Novartis Investigative Site
Thouars, 79100
Novartis Investigative Site
Toul, 54201
Novartis Investigative Site
Toulon, 83000
Novartis Investigative Site
Toulouse, 31059
Novartis Investigative Site
Toulouse, 31077
Novartis Investigative Site
Tours, 37044
Novartis Investigative Site
Tulle, 19000
Novartis Investigative Site
Vandoeuvre Les Nancys, 54511
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
Novartis Investigative Site
Vénissieux, 69200
Novartis Investigative Site
Vernon, France, 27207
Novartis Investigative Site
Vesoul, 70014
Novartis Investigative Site
Vienne, 38200
Novartis Investigative Site
Villefranche-sur-Saône, 69655

Other trials in France

About this study

Official title: Study of the Predictive Value of Airway Obstruction Reversibility on the Effectiveness of Indacaterol (Onbrez® Breezhaler ®) 150 mcg Once Daily in Patients With Moderate to Severe COPD

In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Indacaterol
Keywords: Indacaterol, COPD, LABA, Reversibility
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

IndacaterolDrug
Indacaterol 150 µg once-daily via single-dose dry powder inhaler

Study groups in NCT01272362
Study group	Role	What they receive
Indacaterol	Experimental	Not described Receives: Drug: Indacaterol

What is being measured

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

Coefficient of correlation between FEV1 and reversibility
Coefficient of correlation between the change from baseline in FEV1 with indacaterol after 1 month and the reversibility to salbutamol at screening
Measured: After 1 month

Secondary outcomes (1)

Coefficient of correlation between VQ11 (an assessment of quality of life) and reversibility
Coefficient of correlation between the change from baseline in VQ11 with indacaterol after 5 months and the reversibility to salbutamol at screening
Measured: 5 months

Timeline

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

Apr 2010May 2012

First posted7 Jan 2011 (estimated)
Study startApr 2010
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 625 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01272362
Sponsor's protocol ID: CQAB149BFR01
Other IDs: 2010-022831-12
Acronym: REVERBREZ
Status last verified: Nov 2016
First submitted: 5 Jan 2011
Last updated: 16 Nov 2016
Results posted: No

Publications

Burgel PR, Le Gros V, Decuypere L, Bourdeix I, Perez T, Deslee G. Immediate salbutamol responsiveness does not predict long-term benefits of indacaterol in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2017 Jan 31;17(1):25. doi: 10.1186/s12890-017-0372-z.
PubMed 28143447

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

RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Recruiting
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
COPD - Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
Recruiting
Study on Impact of Maximal Strength Training in Patients With COPD
Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Active, not recruiting
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Oxygen Deficiency, COPD Exacerbation

All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Predictive Value of Airway Obstruction Reversibility on the Effectiveness of Indacaterol (Onbrez® Breezhaler ®) 150 mcg Once Daily in Patients With Moderate to Severe COPD
ClinicalTrials.gov ID: NCT01272362
Acronym / sponsor ID: REVERBREZ / CQAB149BFR01
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Indacaterol, COPD, LABA, Reversibility
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 625 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 7 Jan 2011 (estimated)
Results: Not posted in the source record

Clinical summary

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

In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Indacaterol	Experimental	Drug: Indacaterol

Who may qualify

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

Key inclusion criteria (4 listed)

Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:
Smoking history of at least 10 pack-years

Key exclusion criteria (8 listed)

Patients who have had a COPD exacerbation in the 6 weeks prior to screening
Patients who have had a respiratory tract infection within 4 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II

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
IndacaterolIndacaterol 150 µg once-daily via single-dose dry powder inhaler	Drug	Indacaterol

Primary outcome

Coefficient of correlation between FEV1 and reversibility
Time frame: After 1 month
Coefficient of correlation between the change from baseline in FEV1 with indacaterol after 1 month and the reversibility to salbutamol at screening

1 secondary outcome

Coefficient of correlation between VQ11 (an assessment of quality of life) and reversibility
Time frame: 5 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
Derived from this study: PubMed 28143447Burgel PR, Le Gros V, Decuypere L, Bourdeix I, Perez T, Deslee G. Immediate salbutamol responsiveness does not predict long-term benefits of indacaterol in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2017 Jan 31;17(1):25. doi: 10.1186/s12890-017-0372-z.
JournalLink provided by the sponsor.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Recruiting
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
COPD - Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
Recruiting
Study on Impact of Maximal Strength Training in Patients With COPD
Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Active, not recruiting
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Oxygen Deficiency, COPD Exacerbation

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

137 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Indacaterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 137 sites in France.

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 4 inclusion and 8 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 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in France. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Coefficient of correlation between FEV1 and reversibility (time frame: After 1 month). 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 NCT01272362, 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 16 Nov 2016.