To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol
REVERBREZ
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
2 other identifiers
interventional
625
1 country
137
Brief Summary
In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2010
Typical duration for phase_4
137 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 5, 2011
CompletedFirst Posted
Study publicly available on registry
January 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedNovember 16, 2016
November 1, 2016
2.1 years
January 5, 2011
November 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
After 1 month
Secondary Outcomes (1)
Coefficient of correlation between VQ11 (an assessment of quality of life) and reversibility
5 months
Study Arms (1)
Indacaterol
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (137)
Novartis Investigative Site
Ferolles-Attily, France, 77150, France
Novartis Investigative Site
Suresnes, France, 92150, France
Novartis Investigative Site
Vernon, France, 27207, France
Novartis Investigative Site
Abbeville, 80100, France
Novartis Investigative Site
Ajaccio, 20000, France
Novartis Investigative Site
Albi, 81000, France
Novartis Investigative Site
Albi, 81030, France
Novartis Investigative Site
Amboise, 37403, France
Novartis Investigative Site
Amiens, 80090, France
Novartis Investigative Site
Amiens, 80094, France
Novartis Investigative Site
Angers, 49033, France
Novartis Investigative Site
Angoulême, 16000, France
Novartis Investigative Site
Argenteuil, 95107, France
Novartis Investigative Site
Arles, 13200, France
Novartis Investigative Site
Arles, 13637, France
Novartis Investigative Site
Armentières, 59400, France
Novartis Investigative Site
Aubergenville, 78410, France
Novartis Investigative Site
Bastia, 20200, France
Novartis Investigative Site
Bastia, 20600, France
Novartis Investigative Site
Beauvais, 60021, France
Novartis Investigative Site
Belfort, 90000, France
Novartis Investigative Site
Bergerac, 24108, France
Novartis Investigative Site
Bédarieux, 34600, France
Novartis Investigative Site
Béziers, 34500, France
Novartis Investigative Site
Blois, 41000, France
Novartis Investigative Site
Bois-Guillaume, 76230, France
Novartis Investigative Site
Bordeaux, 33000, France
Novartis Investigative Site
Boulogne-Billancourt, 92104, France
Novartis Investigative Site
Briançon, 05105, France
Novartis Investigative Site
Briey, 54152, France
Novartis Investigative Site
Cambrai, 59400, France
Novartis Investigative Site
Castelnau-le-Lez, 34170, France
Novartis Investigative Site
Ceret, 66400, France
Novartis Investigative Site
Chauny, 02300, France
Novartis Investigative Site
Châteaubriant, 44146, France
Novartis Investigative Site
Châteauroux, 36000, France
Novartis Investigative Site
Châtellerault, 86106, France
Novartis Investigative Site
Chelles, 77500, France
Novartis Investigative Site
Cherbourg Octeville, 50102, France
Novartis Investigative Site
Cholet, 49325, France
Novartis Investigative Site
Cognac, 16108, France
Novartis Investigative Site
Colmar, 68000, France
Novartis Investigative Site
Compiègne, 60200, France
Novartis Investigative Site
Dieulefit, 26220, France
Novartis Investigative Site
Dijon, 21000, France
Novartis Investigative Site
Dijon, 21079, France
Novartis Investigative Site
Dole, 39100, France
Novartis Investigative Site
Ermont, 95120, France
Novartis Investigative Site
Écully, France
Novartis Investigative Site
Forbach, 57600, France
Novartis Investigative Site
Grenoble, 38100, France
Novartis Investigative Site
Grenoble Cédex 9, 38043, France
Novartis Investigative Site
Herblay-sur-Seine, 95220, France
Novartis Investigative Site
Hénin-Beaumont, 62110, France
Novartis Investigative Site
Ismer, 38330, France
Novartis Investigative Site
Jean de Verges, 9000, France
Novartis Investigative Site
L'Aigle, 61305, France
Novartis Investigative Site
La Chausse Saint Victor, 41260, France
Novartis Investigative Site
La Garde, 83130, France
Novartis Investigative Site
La Teste-de-Buch, 32260, France
Novartis Investigative Site
La Teste-de-Buch, 33260, France
Novartis Investigative Site
Le Cannet, 06110, France
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275, France
Novartis Investigative Site
Le Mans, 72037, France
Novartis Investigative Site
Le Perreux-sur-Marne, 94170, France
Novartis Investigative Site
Lens, 62300, France
Novartis Investigative Site
Libourne, 33505, France
Novartis Investigative Site
Lille, 59037, France
Novartis Investigative Site
Lille, 59800, France
Novartis Investigative Site
Limoges, 87042, France
Novartis Investigative Site
Lomme, 59462, France
Novartis Investigative Site
Lunel, 34400, France
Novartis Investigative Site
Lunéville, 54300, France
Novartis Investigative Site
Marseille, 13006, France
Novartis Investigative Site
Metz, 57038, France
Novartis Investigative Site
Molsheim, 67120, France
Novartis Investigative Site
Mont-de-Marsan, 40000, France
Novartis Investigative Site
Mont-Saint-Martin, 54350, France
Novartis Investigative Site
Montauban, 82017, France
Novartis Investigative Site
Montbéliard, 25200, France
Novartis Investigative Site
Montfermeil, 93370, France
Novartis Investigative Site
Montigny-lès-Metz, 57950, France
Novartis Investigative Site
Montpellier, 34070, France
Novartis Investigative Site
Mulhouse, 68070, France
Novartis Investigative Site
Mulhouse, 68100, France
Novartis Investigative Site
Nancy, 54100, France
Novartis Investigative Site
Nantes, 44000, France
Novartis Investigative Site
Nantes, 44093, France
Novartis Investigative Site
Narbonne, 11100, France
Novartis Investigative Site
Nevers, 58000, France
Novartis Investigative Site
Nice, 06000, France
Novartis Investigative Site
Nîmes, 30900, France
Novartis Investigative Site
Obernai, 67210, France
Novartis Investigative Site
Ollioules, 83192, France
Novartis Investigative Site
Paris, 75006, France
Novartis Investigative Site
Paris, 75010, France
Novartis Investigative Site
Paris, 75014, France
Novartis Investigative Site
Paris, 75015, France
Novartis Investigative Site
Paris, 75651, France
Novartis Investigative Site
Perpignan, 66025, France
Novartis Investigative Site
Péronne, 80201, France
Novartis Investigative Site
Pierre-Bénite, 69495, France
Novartis Investigative Site
Poitiers, 86021, France
Novartis Investigative Site
Quimper, 29000, France
Novartis Investigative Site
Reims, 51092, France
Novartis Investigative Site
Rennes, 35700, France
Novartis Investigative Site
Roubaix, 59100, France
Novartis Investigative Site
Rouen, 76031, France
Novartis Investigative Site
Royan, 17200, France
Novartis Investigative Site
Saint-Gaudens, 31806, France
Novartis Investigative Site
Saint-Quentin, 02100, France
Novartis Investigative Site
Saint-Quentin, 02321, France
Novartis Investigative Site
Sainte-Feyre, 23000, France
Novartis Investigative Site
Saintes, 17108, France
Novartis Investigative Site
Salon-de-Provence, 13300, France
Novartis Investigative Site
Sceaux, 92330, France
Novartis Investigative Site
Sélestat, 67600, France
Novartis Investigative Site
Soissons, 02200, France
Novartis Investigative Site
Strasbourg, 67000, France
Novartis Investigative Site
Strasbourg, 67100, France
Novartis Investigative Site
Taden, 22100, France
Novartis Investigative Site
Thiais, 94320, France
Novartis Investigative Site
Thionville, 57100, France
Novartis Investigative Site
Thionville, 57126, France
Novartis Investigative Site
Thouars, 79100, France
Novartis Investigative Site
Toul, 54201, France
Novartis Investigative Site
Toulon, 83000, France
Novartis Investigative Site
Toulouse, 31059, France
Novartis Investigative Site
Toulouse, 31077, France
Novartis Investigative Site
Tours, 37044, France
Novartis Investigative Site
Tulle, 19000, France
Novartis Investigative Site
Vandoeuvre Les Nancys, 54511, France
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511, France
Novartis Investigative Site
Vesoul, 70014, France
Novartis Investigative Site
Vénissieux, 69200, France
Novartis Investigative Site
Vienne, 38200, France
Novartis Investigative Site
Villefranche-sur-Saône, 69655, France
Related Publications (1)
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.
PMID: 28143447DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2011
First Posted
January 7, 2011
Study Start
April 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
November 16, 2016
Record last verified: 2016-11