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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

625

Phase

  • 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

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
Intervention / Treatment
Experimental: Indacaterol
Drug: Indacaterol
Indacaterol 150 µg once-daily via single-dose dry powder inhaler

What is the study measuring?

Primary Outcome Measures

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

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

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

April 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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