Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022831-12 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol | Drug | Indacaterol 150 µg once-daily via single-dose dry powder inhaler |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
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
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ferolles-Attily | France | 77150 | France | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28143447 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C510790 | indacaterol |
Not provided
Not provided
Not provided