To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol (REVERBREZ)

November 14, 2016 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
625

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France, 80100
        • Novartis Investigative Site
      • Ajaccio, France, 20000
        • Novartis Investigative Site
      • Albi, France, 81000
        • Novartis Investigative Site
      • Albi, France, 81030
        • Novartis Investigative Site
      • Amboise, France, 37403
        • Novartis Investigative Site
      • Amiens, France, 80090
        • Novartis Investigative Site
      • Amiens Cedex, France, 80094
        • Novartis Investigative Site
      • Angers Cedex 01, France, 49033
        • Novartis Investigative Site
      • Angouleme, France, 16000
        • Novartis Investigative Site
      • Argenteuil, France, 95107
        • Novartis Investigative Site
      • Arles, France, 13200
        • Novartis Investigative Site
      • Arles cedex, France, 13637
        • Novartis Investigative Site
      • Armentieres, France, 59400
        • Novartis Investigative Site
      • Aubergenville, France, 78410
        • Novartis Investigative Site
      • Bastia, France, 20200
        • Novartis Investigative Site
      • Bastia, France, 20600
        • Novartis Investigative Site
      • Beauvais, France, 60021
        • Novartis Investigative Site
      • Bedarieux, France, 34600
        • Novartis Investigative Site
      • Belfort, France, 90000
        • Novartis Investigative Site
      • Bergerac, France, 24108
        • Novartis Investigative Site
      • Beziers, France, 34500
        • Novartis Investigative Site
      • Blois, France, 41000
        • Novartis Investigative Site
      • Bois Guillaume, France, 76230
        • Novartis Investigative Site
      • Bordeaux, France, 33000
        • Novartis Investigative Site
      • Boulogne Billancourt, France, 92104
        • Novartis Investigative Site
      • Briancon, France, 05105
        • Novartis Investigative Site
      • Briey, France, 54152
        • Novartis Investigative Site
      • Cambrai, France, 59400
        • Novartis Investigative Site
      • Castelnau-le-Lez, France, 34170
        • Novartis Investigative Site
      • Ceret, France, 66400
        • Novartis Investigative Site
      • Chateaubriant, France, 44146
        • Novartis Investigative Site
      • Chateauroux, France, 36000
        • Novartis Investigative Site
      • Chatellerault, France, 86106
        • Novartis Investigative Site
      • Chauny, France, 02300
        • Novartis Investigative Site
      • Chelles, France, 77500
        • Novartis Investigative Site
      • Cherbourg Octeville, France, 50102
        • Novartis Investigative Site
      • Cholet, France, 49325
        • Novartis Investigative Site
      • Cognac, France, 16108
        • Novartis Investigative Site
      • Colmar, France, 68000
        • Novartis Investigative Site
      • Compiegne, France, 60200
        • Novartis Investigative Site
      • Dieulefit, France, 26220
        • Novartis Investigative Site
      • Dijon, France, 21079
        • Novartis Investigative Site
      • Dijon, France, 21000
        • Novartis Investigative Site
      • Dole, France, 39100
        • Novartis Investigative Site
      • Ecully, France
        • Novartis Investigative Site
      • Ermont, France, 95120
        • Novartis Investigative Site
      • Ferolles-Attily, France, 77150
        • Novartis Investigative Site
      • Forbach, France, 57600
        • Novartis Investigative Site
      • Grenoble, France, 38100
        • Novartis Investigative Site
      • Grenoble Cédex 9, France, 38043
        • Novartis Investigative Site
      • Henin Beaumont, France, 62110
        • Novartis Investigative Site
      • Herblay, France, 95220
        • Novartis Investigative Site
      • Ismer, France, 38330
        • Novartis Investigative Site
      • Jean de Verges, France, 9000
        • Novartis Investigative Site
      • L'Aigle, France, 61305
        • Novartis Investigative Site
      • La Chausse Saint Victor, France, 41260
        • Novartis Investigative Site
      • La Garde, France, 83130
        • Novartis Investigative Site
      • La Teste de Buch, France, 32260
        • Novartis Investigative Site
      • La Teste de Buch, France, 33260
        • Novartis Investigative Site
      • Le Cannet, France, 06110
        • Novartis Investigative Site
      • Le Kremlin Bicetre, France, 94275
        • Novartis Investigative Site
      • Le Mans Cedex 09, France, 72037
        • Novartis Investigative Site
      • Le Perreux sur Marne, France, 94170
        • Novartis Investigative Site
      • Lens, France, 62300
        • Novartis Investigative Site
      • Libourne, France, 33505
        • Novartis Investigative Site
      • Lille, France, 59800
        • Novartis Investigative Site
      • Lille Cedex, France, 59037
        • Novartis Investigative Site
      • Limoges Cedex, France, 87042
        • Novartis Investigative Site
      • Lomme, France, 59462
        • Novartis Investigative Site
      • Lunel, France, 34400
        • Novartis Investigative Site
      • Luneville, France, 54300
        • Novartis Investigative Site
      • Marseille, France, 13006
        • Novartis Investigative Site
      • Metz Cedex 01, France, 57038
        • Novartis Investigative Site
      • Molsheim, France, 67120
        • Novartis Investigative Site
      • Mont de Marsan, France, 40000
        • Novartis Investigative Site
      • Mont saint Martin, France, 54350
        • Novartis Investigative Site
      • Montauban, France, 82017
        • Novartis Investigative Site
      • Montbeliard, France, 25200
        • Novartis Investigative Site
      • Montfermeil, France, 93370
        • Novartis Investigative Site
      • Montigny Les Metz, France, 57950
        • Novartis Investigative Site
      • Montpellier, France, 34070
        • Novartis Investigative Site
      • Mulhouse, France, 68100
        • Novartis Investigative Site
      • Mulhouse cedex, France, 68070
        • Novartis Investigative Site
      • Nancy, France, 54100
        • Novartis Investigative Site
      • Nantes, France, 44093
        • Novartis Investigative Site
      • Nantes, France, 44000
        • Novartis Investigative Site
      • Narbonne, France, 11100
        • Novartis Investigative Site
      • Nevers, France, 58000
        • Novartis Investigative Site
      • Nice, France, 06000
        • Novartis Investigative Site
      • Nimes, France, 30900
        • Novartis Investigative Site
      • Obernai, France, 67210
        • Novartis Investigative Site
      • Ollioules Cedex, France, 83192
        • Novartis Investigative Site
      • Paris, France, 75006
        • Novartis Investigative Site
      • Paris, France, 75014
        • Novartis Investigative Site
      • Paris, France, 75015
        • Novartis Investigative Site
      • Paris, France, 75010
        • Novartis Investigative Site
      • Paris Cedex 13, France, 75651
        • Novartis Investigative Site
      • Peronne, France, 80201
        • Novartis Investigative Site
      • Perpignan Cedex, France, 66025
        • Novartis Investigative Site
      • Pierre Benite, France, 69495
        • Novartis Investigative Site
      • Poitiers Cedex, France, 86021
        • Novartis Investigative Site
      • Quimper, France, 29000
        • Novartis Investigative Site
      • Reims, France, 51092
        • Novartis Investigative Site
      • Rennes, France, 35700
        • Novartis Investigative Site
      • Roubaix, France, 59100
        • Novartis Investigative Site
      • Rouen, France, 76031
        • Novartis Investigative Site
      • Royan, France, 17200
        • Novartis Investigative Site
      • Saint Quentin, France, 02100
        • Novartis Investigative Site
      • Saint gaudens, France, 31806
        • Novartis Investigative Site
      • Sainte Feyre, France, 23000
        • Novartis Investigative Site
      • Saintes, France, 17108
        • Novartis Investigative Site
      • Salon de Provence, France, 13300
        • Novartis Investigative Site
      • Sceaux, France, 92330
        • Novartis Investigative Site
      • Selestat, France, 67600
        • Novartis Investigative Site
      • Soissons, France, 02200
        • Novartis Investigative Site
      • St Quentin Cedex, France, 02321
        • Novartis Investigative Site
      • Strasbourg, France, 67000
        • Novartis Investigative Site
      • Strasbourg, France, 67100
        • Novartis Investigative Site
      • Suresnes, France, 92150
        • Novartis Investigative Site
      • Taden, France, 22100
        • Novartis Investigative Site
      • Thiais, France, 94320
        • Novartis Investigative Site
      • Thionville, France, 57100
        • Novartis Investigative Site
      • Thionville cedex, France, 57126
        • Novartis Investigative Site
      • Thouars, France, 79100
        • Novartis Investigative Site
      • Toul, France, 54201
        • Novartis Investigative Site
      • Toulon, France, 83000
        • Novartis Investigative Site
      • Toulouse Cedex 9, France, 31059
        • Novartis Investigative Site
      • Toulouse cedex 4, France, 31077
        • Novartis Investigative Site
      • Tours Cedex 9, France, 37044
        • Novartis Investigative Site
      • Tulle, France, 19000
        • Novartis Investigative Site
      • Vandoeuvre Les Nancys, France, 54511
        • Novartis Investigative Site
      • Vandoeuvre les Nancy, France, 54511
        • Novartis Investigative Site
      • Venissieux, France, 69200
        • Novartis Investigative Site
      • Vernon, France, 27207
        • Novartis Investigative Site
      • Vesoul, France, 70014
        • Novartis Investigative Site
      • Vienne, France, 38200
        • Novartis Investigative Site
      • Villefranche sur Saone, France, 69655
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:

    1. Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
    2. Post-bronchodilator FEV1/FVC (forced vital capacity) <70%
  • Smoking history of at least 10 pack-years

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Indacaterol
Drug: Indacaterol
Indacaterol 150 µg once-daily via single-dose dry powder inhaler

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
After 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coefficient of correlation between VQ11 (an assessment of quality of life) and reversibility
Time Frame: 5 months
Coefficient of correlation between the change from baseline in VQ11 with indacaterol after 5 months and the reversibility to salbutamol at screening
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQAB149BFR01
  • 2010-022831-12 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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