Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— REVERBREZOfficial 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.
| Status | Completed |
| Enrollment | 625 |
| Est. completion date | May 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Novartis Investigative Site | Abbeville | |
| France | Novartis Investigative Site | Ajaccio | |
| France | Novartis Investigative Site | Albi | |
| France | Novartis Investigative Site | Albi | |
| France | Novartis Investigative Site | Amboise | |
| France | Novartis Investigative Site | Amiens | |
| France | Novartis Investigative Site | Amiens Cedex | |
| France | Novartis Investigative Site | Angers Cedex 01 | |
| France | Novartis Investigative Site | Angouleme | |
| France | Novartis Investigative Site | Argenteuil | |
| France | Novartis Investigative Site | Arles | |
| France | Novartis Investigative Site | Arles cedex | |
| France | Novartis Investigative Site | Armentieres | |
| France | Novartis Investigative Site | Aubergenville | |
| France | Novartis Investigative Site | Bastia | |
| France | Novartis Investigative Site | Bastia | |
| France | Novartis Investigative Site | Beauvais | |
| France | Novartis Investigative Site | Bedarieux | |
| France | Novartis Investigative Site | Belfort | |
| France | Novartis Investigative Site | Bergerac | |
| France | Novartis Investigative Site | Beziers | |
| France | Novartis Investigative Site | Blois | |
| France | Novartis Investigative Site | Bois Guillaume | |
| France | Novartis Investigative Site | Bordeaux | |
| France | Novartis Investigative Site | Boulogne Billancourt | |
| France | Novartis Investigative Site | Briancon | |
| France | Novartis Investigative Site | Briey | |
| France | Novartis Investigative Site | Cambrai | |
| France | Novartis Investigative Site | Castelnau-le-Lez | |
| France | Novartis Investigative Site | Ceret | |
| France | Novartis Investigative Site | Chateaubriant | |
| France | Novartis Investigative Site | Chateauroux | |
| France | Novartis Investigative Site | Chatellerault | |
| France | Novartis Investigative Site | Chauny | |
| France | Novartis Investigative Site | Chelles | |
| France | Novartis Investigative Site | Cherbourg Octeville | |
| France | Novartis Investigative Site | Cholet | |
| France | Novartis Investigative Site | Cognac | |
| France | Novartis Investigative Site | Colmar | |
| France | Novartis Investigative Site | Compiegne | |
| France | Novartis Investigative Site | Dieulefit | |
| France | Novartis Investigative Site | Dijon | |
| France | Novartis Investigative Site | Dijon | |
| France | Novartis Investigative Site | Dole | |
| France | Novartis Investigative Site | Ecully | |
| France | Novartis Investigative Site | Ermont | |
| France | Novartis Investigative Site | Ferolles-Attily | |
| France | Novartis Investigative Site | Forbach | |
| France | Novartis Investigative Site | Grenoble | |
| France | Novartis Investigative Site | Grenoble Cédex 9 | |
| France | Novartis Investigative Site | Henin Beaumont | |
| France | Novartis Investigative Site | Herblay | |
| France | Novartis Investigative Site | Ismer | |
| France | Novartis Investigative Site | Jean de Verges | |
| France | Novartis Investigative Site | L'Aigle | |
| France | Novartis Investigative Site | La Chausse Saint Victor | |
| France | Novartis Investigative Site | La Garde | |
| France | Novartis Investigative Site | La Teste de Buch | |
| France | Novartis Investigative Site | La Teste de Buch | |
| France | Novartis Investigative Site | Le Cannet | |
| France | Novartis Investigative Site | Le Kremlin Bicetre | |
| France | Novartis Investigative Site | Le Mans Cedex 09 | |
| France | Novartis Investigative Site | Le Perreux sur Marne | |
| France | Novartis Investigative Site | Lens | |
| France | Novartis Investigative Site | Libourne | |
| France | Novartis Investigative Site | Lille | |
| France | Novartis Investigative Site | Lille Cedex | |
| France | Novartis Investigative Site | Limoges Cedex | |
| France | Novartis Investigative Site | Lomme | |
| France | Novartis Investigative Site | Lunel | |
| France | Novartis Investigative Site | Luneville | |
| France | Novartis Investigative Site | Marseille | |
| France | Novartis Investigative Site | Metz Cedex 01 | |
| France | Novartis Investigative Site | Molsheim | |
| France | Novartis Investigative Site | Mont de Marsan | |
| France | Novartis Investigative Site | Mont saint Martin | |
| France | Novartis Investigative Site | Montauban | |
| France | Novartis Investigative Site | Montbeliard | |
| France | Novartis Investigative Site | Montfermeil | |
| France | Novartis Investigative Site | Montigny Les Metz | |
| France | Novartis Investigative Site | Montpellier | |
| France | Novartis Investigative Site | Mulhouse | |
| France | Novartis Investigative Site | Mulhouse cedex | |
| France | Novartis Investigative Site | Nancy | |
| France | Novartis Investigative Site | Nantes | |
| France | Novartis Investigative Site | Nantes | |
| France | Novartis Investigative Site | Narbonne | |
| France | Novartis Investigative Site | Nevers | |
| France | Novartis Investigative Site | Nice | |
| France | Novartis Investigative Site | Nimes | |
| France | Novartis Investigative Site | Obernai | |
| France | Novartis Investigative Site | Ollioules Cedex | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Paris Cedex 13 | |
| France | Novartis Investigative Site | Peronne | |
| France | Novartis Investigative Site | Perpignan Cedex | |
| France | Novartis Investigative Site | Pierre Benite | |
| France | Novartis Investigative Site | Poitiers Cedex | |
| France | Novartis Investigative Site | Quimper | |
| France | Novartis Investigative Site | Reims | |
| France | Novartis Investigative Site | Rennes | |
| France | Novartis Investigative Site | Roubaix | |
| France | Novartis Investigative Site | Rouen | |
| France | Novartis Investigative Site | Royan | |
| France | Novartis Investigative Site | Saint gaudens | |
| France | Novartis Investigative Site | Saint Quentin | |
| France | Novartis Investigative Site | Sainte Feyre | |
| France | Novartis Investigative Site | Saintes | |
| France | Novartis Investigative Site | Salon de Provence | |
| France | Novartis Investigative Site | Sceaux | |
| France | Novartis Investigative Site | Selestat | |
| France | Novartis Investigative Site | Soissons | |
| France | Novartis Investigative Site | St Quentin Cedex | |
| France | Novartis Investigative Site | Strasbourg | |
| France | Novartis Investigative Site | Strasbourg | |
| France | Novartis Investigative Site | Suresnes | |
| France | Novartis Investigative Site | Taden | |
| France | Novartis Investigative Site | Thiais | |
| France | Novartis Investigative Site | Thionville | |
| France | Novartis Investigative Site | Thionville cedex | |
| France | Novartis Investigative Site | Thouars | |
| France | Novartis Investigative Site | Toul | |
| France | Novartis Investigative Site | Toulon | |
| France | Novartis Investigative Site | Toulouse cedex 4 | |
| France | Novartis Investigative Site | Toulouse Cedex 9 | |
| France | Novartis Investigative Site | Tours Cedex 9 | |
| France | Novartis Investigative Site | Tulle | |
| France | Novartis Investigative Site | Vandoeuvre les Nancy | |
| France | Novartis Investigative Site | Vandoeuvre Les Nancys | |
| France | Novartis Investigative Site | Venissieux | |
| France | Novartis Investigative Site | Vernon | |
| France | Novartis Investigative Site | Vesoul | |
| France | Novartis Investigative Site | Vienne | |
| France | Novartis Investigative Site | Villefranche sur Saone |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | 5 months | No |
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