To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol
NCT ID: NCT01272362
Last Updated: 2016-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
625 participants
INTERVENTIONAL
2010-04-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Indacaterol
Indacaterol
Indacaterol 150 µg once-daily via single-dose dry powder inhaler
Interventions
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Indacaterol
Indacaterol 150 µg once-daily via single-dose dry powder inhaler
Eligibility Criteria
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Inclusion Criteria
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 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
40 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Ferolles-Attily, France, France
Novartis Investigative Site
Suresnes, France, France
Novartis Investigative Site
Vernon, France, France
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Abbeville, , France
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Ajaccio, , France
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Albi, , France
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Albi, , France
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Amboise, , France
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Amiens, , France
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Amiens, , France
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Angers, , France
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Angoulême, , France
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Argenteuil, , France
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Arles, , France
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Arles, , France
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Armentières, , France
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Aubergenville, , France
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Bastia, , France
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Bastia, , France
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Beauvais, , France
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Belfort, , France
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Bergerac, , France
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Bédarieux, , France
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Béziers, , France
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Blois, , France
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Bois-Guillaume, , France
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Bordeaux, , France
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Boulogne-Billancourt, , France
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Briançon, , France
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Briey, , France
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Cambrai, , France
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Castelnau-le-Lez, , France
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Ceret, , France
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Chauny, , France
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Châteaubriant, , France
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Châteauroux, , France
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Châtellerault, , France
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Chelles, , France
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Cherbourg Octeville, , France
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Cholet, , France
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Cognac, , France
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Colmar, , France
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Compiègne, , France
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Dieulefit, , France
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Dijon, , France
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Dijon, , France
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Dole, , France
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Ermont, , France
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Écully, , France
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Forbach, , France
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Grenoble, , France
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Grenoble Cédex 9, , France
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Herblay-sur-Seine, , France
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Hénin-Beaumont, , France
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Ismer, , France
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Jean de Verges, , France
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L'Aigle, , France
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La Chausse Saint Victor, , France
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La Garde, , France
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La Teste-de-Buch, , France
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La Teste-de-Buch, , France
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Le Cannet, , France
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Le Kremlin-Bicêtre, , France
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Le Mans, , France
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Le Perreux-sur-Marne, , France
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Lens, , France
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Libourne, , France
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Lille, , France
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Lille, , France
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Limoges, , France
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Lomme, , France
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Lunel, , France
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Lunéville, , France
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Marseille, , France
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Metz, , France
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Molsheim, , France
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Mont-de-Marsan, , France
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Mont-Saint-Martin, , France
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Montauban, , France
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Montbéliard, , France
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Montfermeil, , France
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Montigny-lès-Metz, , France
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Montpellier, , France
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Mulhouse, , France
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Mulhouse, , France
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Nancy, , France
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Nantes, , France
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Nantes, , France
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Narbonne, , France
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Nevers, , France
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Nice, , France
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Nîmes, , France
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Obernai, , France
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Ollioules, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Perpignan, , France
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Péronne, , France
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Pierre-Bénite, , France
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Poitiers, , France
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Quimper, , France
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Reims, , France
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Rennes, , France
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Roubaix, , France
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Rouen, , France
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Royan, , France
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Saint-Gaudens, , France
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Saint-Quentin, , France
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Saint-Quentin, , France
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Sainte-Feyre, , France
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Saintes, , France
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Salon-de-Provence, , France
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Sceaux, , France
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Sélestat, , France
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Soissons, , France
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Strasbourg, , France
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Strasbourg, , France
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Taden, , France
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Thiais, , France
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Thionville, , France
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Thionville, , France
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Thouars, , France
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Toul, , France
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Toulon, , France
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Toulouse, , France
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Toulouse, , France
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Tours, , France
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Tulle, , France
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Vandoeuvre Les Nancys, , France
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Vandœuvre-lès-Nancy, , France
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Vesoul, , France
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Vénissieux, , France
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Vienne, , France
Novartis Investigative Site
Villefranche-sur-Saône, , France
Countries
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References
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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.
Other Identifiers
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2010-022831-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQAB149BFR01
Identifier Type: -
Identifier Source: org_study_id