Clinical trial NCT01272362: To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Indacaterol
COPD
LABA
Reversibility
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 625
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Coefficient of correlation between FEV1 and reversibility
timeFrame: After 1 month
Secondary outcomes:
measure: Coefficient of correlation between VQ11 (an assessment of quality of life) and reversibility
timeFrame: 5 months
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Novartis Investigative Site
city: Ajaccio
country: France
facility: Novartis Investigative Site
city: Albi
country: France
facility: Novartis Investigative Site
city: Albi
country: France
facility: Novartis Investigative Site
city: Amboise
country: France
facility: Novartis Investigative Site
city: Amiens Cedex
country: France
facility: Novartis Investigative Site
city: Amiens
country: France
facility: Novartis Investigative Site
city: Angers Cedex 01
country: France
facility: Novartis Investigative Site
city: Angouleme
country: France
facility: Novartis Investigative Site
city: Argenteuil
country: France
facility: Novartis Investigative Site
city: Arles cedex
country: France
facility: Novartis Investigative Site
city: Arles
country: France
facility: Novartis Investigative Site
city: Armentieres
country: France
facility: Novartis Investigative Site
city: Aubergenville
country: France
facility: Novartis Investigative Site
city: Bastia
country: France
facility: Novartis Investigative Site
city: Bastia
country: France
facility: Novartis Investigative Site
city: Beauvais
country: France
facility: Novartis Investigative Site
city: Bedarieux
country: France
facility: Novartis Investigative Site
city: Belfort
country: France
facility: Novartis Investigative Site
city: Bergerac
country: France
facility: Novartis Investigative Site
city: Beziers
country: France
facility: Novartis Investigative Site
city: Blois
country: France
facility: Novartis Investigative Site
city: Bois Guillaume
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Boulogne Billancourt
country: France
facility: Novartis Investigative Site
city: Briancon
country: France
facility: Novartis Investigative Site
city: Briey
country: France
facility: Novartis Investigative Site
city: Cambrai
country: France
facility: Novartis Investigative Site
city: Castelnau-le-Lez
country: France
facility: Novartis Investigative Site
city: Ceret
country: France
facility: Novartis Investigative Site
city: Chateaubriant
country: France
facility: Novartis Investigative Site
city: Chateauroux
country: France
facility: Novartis Investigative Site
city: Chatellerault
country: France
facility: Novartis Investigative Site
city: Chauny
country: France
facility: Novartis Investigative Site
city: Chelles
country: France
facility: Novartis Investigative Site
city: Cherbourg Octeville
country: France
facility: Novartis Investigative Site
city: Cholet
country: France
facility: Novartis Investigative Site
city: Cognac
country: France
facility: Novartis Investigative Site
city: Colmar
country: France
facility: Novartis Investigative Site
city: Compiegne
country: France
facility: Novartis Investigative Site
city: Dieulefit
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Dole
country: France
facility: Novartis Investigative Site
city: Ecully
country: France
facility: Novartis Investigative Site
city: Ermont
country: France
facility: Novartis Investigative Site
city: Ferolles-Attily
country: France
facility: Novartis Investigative Site
city: Forbach
country: France
facility: Novartis Investigative Site
city: Grenoble Cédex 9
country: France
facility: Novartis Investigative Site
city: Grenoble
country: France
facility: Novartis Investigative Site
city: Henin Beaumont
country: France
facility: Novartis Investigative Site
city: Herblay
country: France
facility: Novartis Investigative Site
city: Ismer
country: France
facility: Novartis Investigative Site
city: Jean de Verges
country: France
facility: Novartis Investigative Site
city: L'Aigle
country: France
facility: Novartis Investigative Site
city: La Chausse Saint Victor
country: France
facility: Novartis Investigative Site
city: La Garde
country: France
facility: Novartis Investigative Site
city: La Teste de Buch
country: France
facility: Novartis Investigative Site
city: La Teste de Buch
country: France
facility: Novartis Investigative Site
city: Le Cannet
country: France
facility: Novartis Investigative Site
city: Le Kremlin Bicetre
country: France
facility: Novartis Investigative Site
city: Le Mans Cedex 09
country: France
facility: Novartis Investigative Site
city: Le Perreux sur Marne
country: France
facility: Novartis Investigative Site
city: Lens
country: France
facility: Novartis Investigative Site
city: Libourne
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Limoges Cedex
country: France
facility: Novartis Investigative Site
city: Lomme
country: France
facility: Novartis Investigative Site
city: Lunel
country: France
facility: Novartis Investigative Site
city: Luneville
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Metz Cedex 01
country: France
facility: Novartis Investigative Site
city: Molsheim
country: France
facility: Novartis Investigative Site
city: Mont de Marsan
country: France
facility: Novartis Investigative Site
city: Mont saint Martin
country: France
facility: Novartis Investigative Site
city: Montauban
country: France
facility: Novartis Investigative Site
city: Montbeliard
country: France
facility: Novartis Investigative Site
city: Montfermeil
country: France
facility: Novartis Investigative Site
city: Montigny Les Metz
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Mulhouse cedex
country: France
facility: Novartis Investigative Site
city: Mulhouse
country: France
facility: Novartis Investigative Site
city: Nancy
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Narbonne
country: France
facility: Novartis Investigative Site
city: Nevers
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Nimes
country: France
facility: Novartis Investigative Site
city: Obernai
country: France
facility: Novartis Investigative Site
city: Ollioules Cedex
country: France
facility: Novartis Investigative Site
city: Paris Cedex 13
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Peronne
country: France
facility: Novartis Investigative Site
city: Perpignan Cedex
country: France
facility: Novartis Investigative Site
city: Pierre Benite
country: France
facility: Novartis Investigative Site
city: Poitiers Cedex
country: France
facility: Novartis Investigative Site
city: Quimper
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: Roubaix
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Royan
country: France
facility: Novartis Investigative Site
city: Saint gaudens
country: France
facility: Novartis Investigative Site
city: Saint Quentin
country: France
facility: Novartis Investigative Site
city: Sainte Feyre
country: France
facility: Novartis Investigative Site
city: Saintes
country: France
facility: Novartis Investigative Site
city: Salon de Provence
country: France
facility: Novartis Investigative Site
city: Sceaux
country: France
facility: Novartis Investigative Site
city: Selestat
country: France
facility: Novartis Investigative Site
city: Soissons
country: France
facility: Novartis Investigative Site
city: St Quentin Cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Suresnes
country: France
facility: Novartis Investigative Site
city: Taden
country: France
facility: Novartis Investigative Site
city: Thiais
country: France
facility: Novartis Investigative Site
city: Thionville cedex
country: France
facility: Novartis Investigative Site
city: Thionville
country: France
facility: Novartis Investigative Site
city: Thouars
country: France
facility: Novartis Investigative Site
city: Toulon
country: France
facility: Novartis Investigative Site
city: Toulouse cedex 4
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 9
country: France
facility: Novartis Investigative Site
city: Toul
country: France
facility: Novartis Investigative Site
city: Tours Cedex 9
country: France
facility: Novartis Investigative Site
city: Tulle
country: France
facility: Novartis Investigative Site
city: Vandoeuvre Les Nancys
country: France
facility: Novartis Investigative Site
city: Vandoeuvre les Nancy
country: France
facility: Novartis Investigative Site
city: Venissieux
country: France
facility: Novartis Investigative Site
city: Vernon
country: France
facility: Novartis Investigative Site
city: Vesoul
country: France
facility: Novartis Investigative Site
city: Vienne
country: France
facility: Novartis Investigative Site
city: Villefranche sur Saone
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.