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To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol (REVERBREZ)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Indacaterol
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Indacaterol, COPD, LABA, Reversibility

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Indacaterol

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2011
Last Updated
November 14, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01272362
Brief Title
To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol
Acronym
REVERBREZ
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Indacaterol, COPD, LABA, Reversibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
625 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Intervention Description
Indacaterol 150 µg once-daily via single-dose dry powder inhaler
Primary Outcome Measure Information:
Title
Coefficient of correlation between FEV1 and reversibility
Description
Coefficient of correlation between the change from baseline in FEV1 with indacaterol after 1 month and the reversibility to salbutamol at screening
Time Frame
After 1 month
Secondary Outcome Measure Information:
Title
Coefficient of correlation between VQ11 (an assessment of quality of life) and reversibility
Description
Coefficient of correlation between the change from baseline in VQ11 with indacaterol after 5 months and the reversibility to salbutamol at screening
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Abbeville
ZIP/Postal Code
80100
Country
France
Facility Name
Novartis Investigative Site
City
Ajaccio
ZIP/Postal Code
20000
Country
France
Facility Name
Novartis Investigative Site
City
Albi
ZIP/Postal Code
81000
Country
France
Facility Name
Novartis Investigative Site
City
Albi
ZIP/Postal Code
81030
Country
France
Facility Name
Novartis Investigative Site
City
Amboise
ZIP/Postal Code
37403
Country
France
Facility Name
Novartis Investigative Site
City
Amiens Cedex
ZIP/Postal Code
80094
Country
France
Facility Name
Novartis Investigative Site
City
Amiens
ZIP/Postal Code
80090
Country
France
Facility Name
Novartis Investigative Site
City
Angers Cedex 01
ZIP/Postal Code
49033
Country
France
Facility Name
Novartis Investigative Site
City
Angouleme
ZIP/Postal Code
16000
Country
France
Facility Name
Novartis Investigative Site
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Novartis Investigative Site
City
Arles cedex
ZIP/Postal Code
13637
Country
France
Facility Name
Novartis Investigative Site
City
Arles
ZIP/Postal Code
13200
Country
France
Facility Name
Novartis Investigative Site
City
Armentieres
ZIP/Postal Code
59400
Country
France
Facility Name
Novartis Investigative Site
City
Aubergenville
ZIP/Postal Code
78410
Country
France
Facility Name
Novartis Investigative Site
City
Bastia
ZIP/Postal Code
20200
Country
France
Facility Name
Novartis Investigative Site
City
Bastia
ZIP/Postal Code
20600
Country
France
Facility Name
Novartis Investigative Site
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Novartis Investigative Site
City
Bedarieux
ZIP/Postal Code
34600
Country
France
Facility Name
Novartis Investigative Site
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Belfort
ZIP/Postal Code
90000
Country
France
Facility Name
Novartis Investigative Site
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Bergerac
ZIP/Postal Code
24108
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France
Facility Name
Novartis Investigative Site
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Beziers
ZIP/Postal Code
34500
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France
Facility Name
Novartis Investigative Site
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Blois
ZIP/Postal Code
41000
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France
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Novartis Investigative Site
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Bois Guillaume
ZIP/Postal Code
76230
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France
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Novartis Investigative Site
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Bordeaux
ZIP/Postal Code
33000
Country
France
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Novartis Investigative Site
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Boulogne Billancourt
ZIP/Postal Code
92104
Country
France
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Novartis Investigative Site
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Briancon
ZIP/Postal Code
05105
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France
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Novartis Investigative Site
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Briey
ZIP/Postal Code
54152
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France
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Novartis Investigative Site
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Cambrai
ZIP/Postal Code
59400
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France
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Novartis Investigative Site
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Castelnau-le-Lez
ZIP/Postal Code
34170
Country
France
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Novartis Investigative Site
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Ceret
ZIP/Postal Code
66400
Country
France
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Novartis Investigative Site
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Chateaubriant
ZIP/Postal Code
44146
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France
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Novartis Investigative Site
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Chateauroux
ZIP/Postal Code
36000
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France
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Chatellerault
ZIP/Postal Code
86106
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France
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Novartis Investigative Site
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Chauny
ZIP/Postal Code
02300
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France
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Chelles
ZIP/Postal Code
77500
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France
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Cherbourg Octeville
ZIP/Postal Code
50102
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France
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Cholet
ZIP/Postal Code
49325
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France
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Cognac
ZIP/Postal Code
16108
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France
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Colmar
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68000
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France
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Compiegne
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60200
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France
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Dieulefit
ZIP/Postal Code
26220
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France
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Dijon
ZIP/Postal Code
21000
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France
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Dijon
ZIP/Postal Code
21079
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France
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Dole
ZIP/Postal Code
39100
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France
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Ecully
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France
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Ermont
ZIP/Postal Code
95120
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France
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Ferolles-Attily
ZIP/Postal Code
77150
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France
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Forbach
ZIP/Postal Code
57600
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France
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Grenoble Cédex 9
ZIP/Postal Code
38043
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France
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Grenoble
ZIP/Postal Code
38100
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France
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Henin Beaumont
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62110
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France
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Herblay
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95220
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38330
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Jean de Verges
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9000
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L'Aigle
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61305
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41260
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France
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La Garde
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83130
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La Teste de Buch
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32260
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La Teste de Buch
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33260
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Le Cannet
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06110
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Le Kremlin Bicetre
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94275
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France
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Le Mans Cedex 09
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72037
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France
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Novartis Investigative Site
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Le Perreux sur Marne
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94170
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France
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Novartis Investigative Site
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Lens
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62300
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France
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Novartis Investigative Site
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Libourne
ZIP/Postal Code
33505
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France
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Novartis Investigative Site
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Lille Cedex
ZIP/Postal Code
59037
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France
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Novartis Investigative Site
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Lille
ZIP/Postal Code
59800
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France
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Limoges Cedex
ZIP/Postal Code
87042
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France
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Lomme
ZIP/Postal Code
59462
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France
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Novartis Investigative Site
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Lunel
ZIP/Postal Code
34400
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France
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Novartis Investigative Site
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Luneville
ZIP/Postal Code
54300
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France
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Novartis Investigative Site
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Marseille
ZIP/Postal Code
13006
Country
France
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Novartis Investigative Site
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Metz Cedex 01
ZIP/Postal Code
57038
Country
France
Facility Name
Novartis Investigative Site
City
Molsheim
ZIP/Postal Code
67120
Country
France
Facility Name
Novartis Investigative Site
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Mont de Marsan
ZIP/Postal Code
40000
Country
France
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Novartis Investigative Site
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Mont saint Martin
ZIP/Postal Code
54350
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France
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Novartis Investigative Site
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Montauban
ZIP/Postal Code
82017
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France
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Montbeliard
ZIP/Postal Code
25200
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France
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Montfermeil
ZIP/Postal Code
93370
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Montigny Les Metz
ZIP/Postal Code
57950
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France
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Montpellier
ZIP/Postal Code
34070
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France
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Mulhouse cedex
ZIP/Postal Code
68070
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France
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Novartis Investigative Site
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Mulhouse
ZIP/Postal Code
68100
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France
Facility Name
Novartis Investigative Site
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Nancy
ZIP/Postal Code
54100
Country
France
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Novartis Investigative Site
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Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Novartis Investigative Site
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Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
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City
Narbonne
ZIP/Postal Code
11100
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France
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Nevers
ZIP/Postal Code
58000
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France
Facility Name
Novartis Investigative Site
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Nice
ZIP/Postal Code
06000
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France
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Novartis Investigative Site
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Nimes
ZIP/Postal Code
30900
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France
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Novartis Investigative Site
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Obernai
ZIP/Postal Code
67210
Country
France
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Novartis Investigative Site
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Ollioules Cedex
ZIP/Postal Code
83192
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France
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Novartis Investigative Site
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Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75015
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France
Facility Name
Novartis Investigative Site
City
Peronne
ZIP/Postal Code
80201
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France
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Novartis Investigative Site
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Perpignan Cedex
ZIP/Postal Code
66025
Country
France
Facility Name
Novartis Investigative Site
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Pierre Benite
ZIP/Postal Code
69495
Country
France
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Novartis Investigative Site
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Novartis Investigative Site
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Quimper
ZIP/Postal Code
29000
Country
France
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Novartis Investigative Site
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Reims
ZIP/Postal Code
51092
Country
France
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Novartis Investigative Site
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Rennes
ZIP/Postal Code
35700
Country
France
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Novartis Investigative Site
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Roubaix
ZIP/Postal Code
59100
Country
France
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Novartis Investigative Site
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Rouen
ZIP/Postal Code
76031
Country
France
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Novartis Investigative Site
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Royan
ZIP/Postal Code
17200
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France
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Novartis Investigative Site
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Saint gaudens
ZIP/Postal Code
31806
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France
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Novartis Investigative Site
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Saint Quentin
ZIP/Postal Code
02100
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France
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Novartis Investigative Site
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Sainte Feyre
ZIP/Postal Code
23000
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France
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Novartis Investigative Site
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Saintes
ZIP/Postal Code
17108
Country
France
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Novartis Investigative Site
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Salon de Provence
ZIP/Postal Code
13300
Country
France
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Novartis Investigative Site
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Sceaux
ZIP/Postal Code
92330
Country
France
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Novartis Investigative Site
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Selestat
ZIP/Postal Code
67600
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France
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Novartis Investigative Site
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Soissons
ZIP/Postal Code
02200
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France
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Novartis Investigative Site
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St Quentin Cedex
ZIP/Postal Code
02321
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France
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Novartis Investigative Site
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Strasbourg
ZIP/Postal Code
67000
Country
France
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Novartis Investigative Site
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Strasbourg
ZIP/Postal Code
67100
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France
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Novartis Investigative Site
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Suresnes
ZIP/Postal Code
92150
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France
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Novartis Investigative Site
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Taden
ZIP/Postal Code
22100
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France
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Novartis Investigative Site
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Thiais
ZIP/Postal Code
94320
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France
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Novartis Investigative Site
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Thionville cedex
ZIP/Postal Code
57126
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France
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Novartis Investigative Site
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Thionville
ZIP/Postal Code
57100
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France
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Novartis Investigative Site
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Thouars
ZIP/Postal Code
79100
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France
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Novartis Investigative Site
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Toulon
ZIP/Postal Code
83000
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France
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Novartis Investigative Site
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Toulouse cedex 4
ZIP/Postal Code
31077
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Novartis Investigative Site
City
Toul
ZIP/Postal Code
54201
Country
France
Facility Name
Novartis Investigative Site
City
Tours Cedex 9
ZIP/Postal Code
37044
Country
France
Facility Name
Novartis Investigative Site
City
Tulle
ZIP/Postal Code
19000
Country
France
Facility Name
Novartis Investigative Site
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Vandoeuvre Les Nancys
ZIP/Postal Code
54511
Country
France
Facility Name
Novartis Investigative Site
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Novartis Investigative Site
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Novartis Investigative Site
City
Vernon
ZIP/Postal Code
27207
Country
France
Facility Name
Novartis Investigative Site
City
Vesoul
ZIP/Postal Code
70014
Country
France
Facility Name
Novartis Investigative Site
City
Vienne
ZIP/Postal Code
38200
Country
France
Facility Name
Novartis Investigative Site
City
Villefranche sur Saone
ZIP/Postal Code
69655
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28143447
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.
Results Reference
derived
Links:
URL
http://erj.ersjournals.com/content/42/Suppl_57/P2500
Description
Journal

Learn more about this trial

To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol

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