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Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indacaterol 150 μg
Salmeterol 50 μg
Placebo to Indacaterol
Placebo to Salmeterol
Sponsored by
Novartis
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 Chronic obstructive pulmonary disease, indacaterol, salmeterol, placebo controlled

Eligibility Criteria

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

Inclusion Criteria:

Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:

  • Smoking history of at least 20 pack years
  • Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% predicted and >or= 30% of predicted normal value
  • Post-bronchodilator FEV1/FVC < 70%

("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

Exclusion Criteria:

  • Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
  • Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in
  • Patients requiring oxygen therapy for chronic hypoxemia (typically >15h/day)
  • Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
  • Concomitant pulmonary disease
  • Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
  • History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for females
  • Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
  • History of reactions to sympathomimetic amines or inhaled medication
  • Inability to use the dry powder devices or perform spirometry
  • Irregular day/night, wake/sleep cycles, e.g. shift workers
  • Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period
  • Patients unable or unwilling to complete a patient diary

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigator Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Indacaterol 150 μg

Placebo

Salmeterol 50 μg

Arm Description

Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.

Secondary Outcome Measures

St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.
Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment
Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of "days of poor control", FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.

Full Information

First Posted
December 4, 2007
Last Updated
July 22, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00567996
Brief Title
Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control
Official Title
A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

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
Chronic obstructive pulmonary disease, indacaterol, salmeterol, placebo controlled

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1002 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 150 μg
Arm Type
Experimental
Arm Description
Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Arm Title
Salmeterol 50 μg
Arm Type
Active Comparator
Arm Description
Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Intervention Type
Drug
Intervention Name(s)
Indacaterol 150 μg
Intervention Description
Indacaterol 150 μg once daily (o.d) inhaled
Intervention Type
Drug
Intervention Name(s)
Salmeterol 50 μg
Intervention Description
Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
Placebo to Indacaterol
Intervention Description
Placebo to Indacaterol inhaled via SDDPI.
Intervention Type
Drug
Intervention Name(s)
Placebo to Salmeterol
Intervention Description
Placebo to salmeterol delivered via a proprietary dry powder inhaler
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
Description
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
Description
SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.
Time Frame
Week 12
Title
Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment
Description
Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of "days of poor control", FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.
Time Frame
Up to 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including: Smoking history of at least 20 pack years Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% predicted and >or= 30% of predicted normal value Post-bronchodilator FEV1/FVC < 70% ("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol) Exclusion Criteria: Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in Patients requiring oxygen therapy for chronic hypoxemia (typically >15h/day) Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period Concomitant pulmonary disease Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of childhood asthma History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for females Patients who have a clinically significant condition or a clinically relevant laboratory abnormality History of reactions to sympathomimetic amines or inhaled medication Inability to use the dry powder devices or perform spirometry Irregular day/night, wake/sleep cycles, e.g. shift workers Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period Patients unable or unwilling to complete a patient diary Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharma AG
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigative Site
City
Edmonton
Country
Canada
Facility Name
Novartis Investigator Site
City
Edmonton
Country
Canada
Facility Name
Novartis Investigator Site
City
London
Country
Canada
Facility Name
Novartis Investigator Site
City
Mirabel
Country
Canada
Facility Name
Novartis Investigator Site
City
Montreal
Country
Canada
Facility Name
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City
Toronto
Country
Canada
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City
Barranquilla
Country
Colombia
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City
Bogota D.C.
Country
Colombia
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City
Medellin
Country
Colombia
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Novartis Investigator Site
City
Cvikov
Country
Czech Republic
Facility Name
Novartis Investigator Site
City
Lovosice
Country
Czech Republic
Facility Name
novartis Investigator site
City
Novy Jocin
Country
Czech Republic
Facility Name
Novartis Investigator Site
City
Pardubice
Country
Czech Republic
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Novartis Investigator Site
City
Praha
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Zatec
Country
Czech Republic
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City
Aalborg
Country
Denmark
Facility Name
Novartis Investigator Site
City
Arhus
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Denmark
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Novartis Investigative Site
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Copenhagen
Country
Denmark
Facility Name
Novartis Investigator Site
City
Copenhagen
Country
Denmark
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City
Frederikssund
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Denmark
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Novartis investigator site
City
Hellerup
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Denmark
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Novartis Investigator site
City
Hvidovre
Country
Denmark
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Novartis investigator site
City
Odense
Country
Denmark
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Novartis Investigator Site
City
Roslev
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Denmark
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Novartis Investigative Site
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Silkeborg
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Denmark
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Soborg
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Denmark
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Vaerloese
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Denmark
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Hus
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Finland
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Jyvaskyla
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Finland
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Lahti
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Finland
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Oulu
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Finland
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Tampere
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Finland
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Turku
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Finland
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Ambroise
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France
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Beuvry
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France
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Ferolles-Attilly
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France
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Nice
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France
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Bad Segeberg
Country
Germany
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Berlin
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Germany
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Bielefeld
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Bruehl
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Germany
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Cottbus
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Germany
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Dortmund
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Germany
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Dueren
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Germany
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City
Eggenfelden
Country
Germany
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Eschwege
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Germany
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City
Forchheim
Country
Germany
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Freudenberg
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Germany
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City
Furth
Country
Germany
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Gelsenkirchen
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Germany
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Gummersbach
Country
Germany
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Hagen
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Germany
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Hannover
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Germany
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Kassel
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Germany
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Kempten
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Germany
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Koeln
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Germany
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Landsberg am Lech
Country
Germany
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Langenfeld
Country
Germany
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Leipzig
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Germany
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Mainz
Country
Germany
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Muenchen
Country
Germany
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Munich
Country
Germany
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Neuss
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Germany
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Nuremburg
Country
Germany
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Oschersleben
Country
Germany
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Ruhmannsfelden
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Germany
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Sinsheim
Country
Germany
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Solingen
Country
Germany
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Steinfort-borghorst
Country
Germany
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Vilshofen
Country
Germany
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Wallerfing
Country
Germany
Facility Name
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City
Witten
Country
Germany
Facility Name
Novartis Investigator Site
City
Budapest
Country
Hungary
Facility Name
Novartis investigator site
City
Debrechen
Country
Hungary
Facility Name
Novartis Investigator Site
City
Deszk
Country
Hungary
Facility Name
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Mosonmagyarovar
Country
Hungary
Facility Name
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Szekesfehervar
Country
Hungary
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Reykhavik
Country
Iceland
Facility Name
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Chennai
Country
India
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Coimbatore
Country
India
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Goa
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India
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Hyderabad
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India
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Jaipur
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India
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Kerala
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India
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Mangalore
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India
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Mumbai
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India
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Vellore
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India
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Ancona
Country
Italy
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Arenzano
Country
Italy
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Novartis Investigative Site
City
Ascoli Piceno
Country
Italy
Facility Name
Novartis Investigator Site
City
Brescia
Country
Italy
Facility Name
Novartis Investigator Site
City
Cagliari
Country
Italy
Facility Name
Novartis investigator site
City
Chieti
Country
Italy
Facility Name
Novartis Investigator Site
City
Ferrara
Country
Italy
Facility Name
Novartis Investigator Site
City
Milano
Country
Italy
Facility Name
Novartis Investigator Site
City
Milan
Country
Italy
Facility Name
Novartis Investigator Site
City
Orbassano
Country
Italy
Facility Name
Novartis Investigator Site
City
Palermo
Country
Italy
Facility Name
Novartis Investigator Site
City
Reggio Emilia
Country
Italy
Facility Name
Novartis Investigator Site
City
Rome
Country
Italy
Facility Name
Novartis Investigator Site
City
Sesto
Country
Italy
Facility Name
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Siena
Country
Italy
Facility Name
Novartis Investigator Site
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Terni
Country
Italy
Facility Name
Novartis Investigator Site
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Callao
Country
Peru
Facility Name
Novartis Investigator Site
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Miraflores
Country
Peru
Facility Name
Novartis Investigator Site
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San Borja
Country
Peru
Facility Name
Novartis Investigator Site
City
San Isidro
Country
Peru
Facility Name
Novartis Investigator Site
City
San Martin de Porres
Country
Peru
Facility Name
Novartis Investigator Site
City
Surco
Country
Peru
Facility Name
Novartis Investigator Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Kazan
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Moscow
Country
Russian Federation
Facility Name
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Saint Petersburg
Country
Russian Federation
Facility Name
Novartis Investigator Site
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Samara
Country
Russian Federation
Facility Name
Novartis Investigator Site
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St Petersburg
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Yekaterinburg
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Bardejov
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Bratislava
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Kosice
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Kovice
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Spisska
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Changhua
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Kaohsiung
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Kaohusing
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Lin-ko
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Taichung
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22158330
Citation
Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13.
Results Reference
derived
PubMed Identifier
21397482
Citation
Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.
Results Reference
derived
PubMed Identifier
21227674
Citation
Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

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