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Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indacaterol
Formoterol
Placebo to indacaterol
Placebo to formoterol
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, COPD, indacaterol, long-acting β2 agonist

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:

    1. Smoking history of at least 20 pack years
    2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value

    3. Post-bronchodilator FEV1/FVC (forced volume capacity) < 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)

      Exclusion Criteria:

  • Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
  • Patients who had a respiratory tract infection within 6 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 co-morbid conditions.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Sites / Locations

  • Novartis Investigator Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Indacaterol 300 μg plus placebo to formoterol

Indacaterol 600 μg plus placebo to formoterol

Formoterol 12 μg plus placebo to indacaterol

Placebo to indacaterol plus placebo to formoterol

Arm Description

Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

Secondary Outcome Measures

Percentage of Days of Poor Control During 52 Weeks of Treatment
Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

Full Information

First Posted
October 25, 2006
Last Updated
July 22, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00393458
Brief Title
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
Official Title
A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
chronic obstructive pulmonary disease, COPD, indacaterol, long-acting β2 agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1732 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 300 μg plus placebo to formoterol
Arm Type
Experimental
Arm Description
Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Arm Title
Indacaterol 600 μg plus placebo to formoterol
Arm Type
Experimental
Arm Description
Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Arm Title
Formoterol 12 μg plus placebo to indacaterol
Arm Type
Active Comparator
Arm Description
Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Arm Title
Placebo to indacaterol plus placebo to formoterol
Arm Type
Placebo Comparator
Arm Description
Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Intervention Description
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Intervention Type
Drug
Intervention Name(s)
Formoterol
Intervention Description
Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
Intervention Type
Drug
Intervention Name(s)
Placebo to indacaterol
Intervention Description
Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Intervention Type
Drug
Intervention Name(s)
Placebo to formoterol
Intervention Description
Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85
Description
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time Frame
Week 12 + 1 day, Day 85
Secondary Outcome Measure Information:
Title
Percentage of Days of Poor Control During 52 Weeks of Treatment
Description
Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time Frame
Baseline to end of study (Week 52)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and: Smoking history of at least 20 pack years Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value Post-bronchodilator FEV1/FVC (forced volume capacity) < 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol) Exclusion Criteria: Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening. Patients who had a respiratory tract infection within 6 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 co-morbid conditions. Other protocol-defined inclusion/exclusion criteria applied to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Investigator Site
Organizational Affiliation
Novartis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigator Site
City
Buenos Aires
Country
Argentina
Facility Name
Novartis
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Buenos Aires
Country
Argentina
Facility Name
Novartis Investigator Site
City
Mendoza
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Argentina
Facility Name
Novartis Investigator Site
City
San Miguel
Country
Argentina
Facility Name
Novartis Investigator Site
City
Santa Fe
Country
Argentina
Facility Name
Novartis Investigator Site
City
Rancagua
Country
Chile
Facility Name
Novartis
City
Santiago
Country
Chile
Facility Name
Novartis Investigator Site
City
Vina del Mar
Country
Chile
Facility Name
Novartis Investigator Site
City
Barranquilla
Country
Colombia
Facility Name
Novartis
City
Bogota
Country
Colombia
Facility Name
Novartis Investigator Site
City
Medellin
Country
Colombia
Facility Name
Novartis Investigator Site
City
Cvikov
Country
Czech Republic
Facility Name
Novartis Investigator Site
City
Kyjov
Country
Czech Republic
Facility Name
Novartis Investigator Site
City
Ostrava Poruba
Country
Czech Republic
Facility Name
Novartis Investigator Site
City
Pardubice
Country
Czech Republic
Facility Name
Novartis
City
Praha
Country
Czech Republic
Facility Name
Novartis Investigator Site
City
Tabor
Country
Czech Republic
Facility Name
Novartis Investigator Site
City
Zatec
Country
Czech Republic
Facility Name
Novartis Investigator Site
City
Aarhus
Country
Denmark
Facility Name
Novartis
City
Copenhagen
Country
Denmark
Facility Name
Novartis Investigator Site
City
Hellerup
Country
Denmark
Facility Name
Novartis Investigator Site
City
Hvidovre
Country
Denmark
Facility Name
Novartis Investigator Site
City
Molleparkvej
Country
Denmark
Facility Name
Novartis Investigator Site
City
Odense
Country
Denmark
Facility Name
Novartis Investigator Site
City
Guayaquil
Country
Ecuador
Facility Name
Novartis Investigator Site
City
Quito
Country
Ecuador
Facility Name
Novartis
City
Quito
Country
Ecuador
Facility Name
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City
Alexandria
Country
Egypt
Facility Name
Novartis Investigator Site
City
Assiut
Country
Egypt
Facility Name
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City
Cairo
Country
Egypt
Facility Name
Novartis
City
Cairo
Country
Egypt
Facility Name
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City
Tallinn
Country
Estonia
Facility Name
Novartis
City
Tartu
Country
Estonia
Facility Name
Novartis Investigator Site
City
Beuvry
Country
France
Facility Name
Novartis Investigator Site
City
Chamalieres
Country
France
Facility Name
Novartis Investigator Site
City
Ferolles-Attilly
Country
France
Facility Name
Novartis Investigator Site
City
Grasse
Country
France
Facility Name
Novartis Investigator Site
City
Marseilles
Country
France
Facility Name
Novartis Investigator Site
City
Montpellier Cedex
Country
France
Facility Name
Novartis Investigator Site
City
Nice
Country
France
Facility Name
Novartis Investigator Site
City
Nimes
Country
France
Facility Name
Novartis Investigator Site
City
Paris
Country
France
Facility Name
Novartis Investigator Site
City
Perpignan
Country
France
Facility Name
Novartis Investigator Site
City
Pessac Cedex
Country
France
Facility Name
Novartis Investigator Site
City
Strasbourg
Country
France
Facility Name
Novartis Investigator Site
City
Augsburg
Country
Germany
Facility Name
Novartis Investigator Site
City
Bad Segeberg
Country
Germany
Facility Name
Novartis Investigator Site
City
Bad Worishofen
Country
Germany
Facility Name
Novartis Investigator Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigator Site
City
Bielefeld
Country
Germany
Facility Name
Novartis Investigator Site
City
Bochum
Country
Germany
Facility Name
Novartis Investigator Site
City
Bonn
Country
Germany
Facility Name
Novartis Investigator Site
City
Borstel
Country
Germany
Facility Name
Novartis Investigator Site
City
Darmstadt
Country
Germany
Facility Name
Novartis Investigator Site
City
Dortmund
Country
Germany
Facility Name
Novartis Investigator Site
City
Erfurt
Country
Germany
Facility Name
Novartis Investigator Site
City
Forchheim
Country
Germany
Facility Name
Novartis Investigator Site
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Frankfurt
Country
Germany
Facility Name
Novartis Investigator Site
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Gauting
Country
Germany
Facility Name
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Geesthacht
Country
Germany
Facility Name
Novartis Investigator Site
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Gelsenkirchen
Country
Germany
Facility Name
Novartis Investigator Site
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Grosshansdorf
Country
Germany
Facility Name
Novartis Investigator Site
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Gummersbach
Country
Germany
Facility Name
Novartis Investigator Site
City
Hagen
Country
Germany
Facility Name
Novartis Investigator Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigator Site
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Hannover
Country
Germany
Facility Name
Novartis Investigator Site
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Ilvesheim
Country
Germany
Facility Name
Novartis Investigator Site
City
Kassel
Country
Germany
Facility Name
Novartis Investigator Site
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Kiel
Country
Germany
Facility Name
Novartis Investigator Site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigator Site
City
Luebeck
Country
Germany
Facility Name
Novartis Investigator Site
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Luedenscheid
Country
Germany
Facility Name
Novartis Investigator Site
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Mainz
Country
Germany
Facility Name
Novartis Investigator Site
City
Marburg
Country
Germany
Facility Name
Novartis Investigator Site
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Muenchen
Country
Germany
Facility Name
Novartis Investigator Site
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Neumunster
Country
Germany
Facility Name
Novartis
City
Nürnberg
Country
Germany
Facility Name
Novartis Investigator Site
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Oschersleben
Country
Germany
Facility Name
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Ruedersdorf
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Germany
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Schoenefeld
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Germany
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Strausberg
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Germany
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Witten
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Germany
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Novartis Investigator Site
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Wuppertal
Country
Germany
Facility Name
Novartis Investigator Site
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Budapest
Country
Hungary
Facility Name
Novartis
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Budapest
Country
Hungary
Facility Name
Novartis Investigator Site
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Deszk
Country
Hungary
Facility Name
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Matrahaza
Country
Hungary
Facility Name
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Mosdos
Country
Hungary
Facility Name
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Sopron
Country
Hungary
Facility Name
Novartis Investigator Site
City
Jerusalem
Country
Israel
Facility Name
Novartis
City
Petach-Tikva
Country
Israel
Facility Name
Novartis Investigator Site
City
Rehovot
Country
Israel
Facility Name
Novartis Investigator Site
City
Tel-Hashomer
Country
Israel
Facility Name
Novartis Investigator Site
City
Ancona
Country
Italy
Facility Name
Novartis Investigator Site
City
Catania
Country
Italy
Facility Name
Novartis Investigator Site
City
Ferrara
Country
Italy
Facility Name
Novartis Investigator Site
City
Firenze
Country
Italy
Facility Name
Novartis Investigator Site
City
Foggia
Country
Italy
Facility Name
Novartis Investigator Site
City
Genova
Country
Italy
Facility Name
Novartis Investigator Site
City
Milano
Country
Italy
Facility Name
Novartis
City
Milano
Country
Italy
Facility Name
Novartis Investigator Site
City
Pisa
Country
Italy
Facility Name
Novartis Investigator Site
City
Roma
Country
Italy
Facility Name
Novartis Investigator Site
City
Siena
Country
Italy
Facility Name
Novartis Investigator Site
City
Kyunggi
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Suwon
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Uijeongbu-si
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Daugavpils
Country
Latvia
Facility Name
Novartis Investigator Site
City
Jekabpils
Country
Latvia
Facility Name
Novartis Investigator Site
City
Riga
Country
Latvia
Facility Name
Novartis
City
Riga
Country
Latvia
Facility Name
Novartis Investigator Site
City
Alytus
Country
Lithuania
Facility Name
Novartis Investigator Site
City
Kaunas
Country
Lithuania
Facility Name
Novartis
City
Kaunas
Country
Lithuania
Facility Name
Novartis Investigator Site
City
Klaipeda
Country
Lithuania
Facility Name
Novartis Investigator Site
City
Vilnius
Country
Lithuania
Facility Name
Novartis Investigator Site
City
Almelo
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Amersfoort
Country
Netherlands
Facility Name
Novartis
City
Arnhem
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Breda
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Ede
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Eindhoven
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Harderwijk
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Helmond
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Hengelo
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Hoorn
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Leeuwarden
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Rotterdam
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Sneek
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Veldhoven
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Zutphen
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Lima
Country
Peru
Facility Name
Novartis
City
Lima
Country
Peru
Facility Name
Novartis
City
Bucharest
Country
Romania
Facility Name
Novartis Investigator Site
City
Cluj-Napoca
Country
Romania
Facility Name
Novartis Investigator Site
City
Iasi
Country
Romania
Facility Name
Novartis Investigator Site
City
Timisoara
Country
Romania
Facility Name
Novartis Investigator Site
City
Kazan
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Moscow
Country
Russian Federation
Facility Name
Novartis
City
Moscow
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Samara
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
St Petersburg
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Yekaterinburg
Country
Russian Federation
Facility Name
Novartis Investigator Site
City
Banska Bystrica
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Bratislava
Country
Slovakia
Facility Name
Novartis
City
Bratislava
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Kosice
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Partizanske
Country
Slovakia
Facility Name
Novartis Investigator Site
City
Alicante
Country
Spain
Facility Name
Novartis Investigator Site
City
Barcelona
Country
Spain
Facility Name
Novartis
City
Barcelona
Country
Spain
Facility Name
Novartis Investigator Site
City
Begonte
Country
Spain
Facility Name
Novartis Investigator Site
City
Caceres
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
Country
Spain
Facility Name
Novartis Investigator Site
City
Mataro
Country
Spain
Facility Name
Novartis Investigator Site
City
Petrel
Country
Spain
Facility Name
Novartis Investigator Site
City
Ponferrada
Country
Spain
Facility Name
Novartis Investigator Site
City
Terrassa
Country
Spain
Facility Name
Novartis Investigator Site
City
Valencia
Country
Spain
Facility Name
Novartis Investigator Site
City
Aarau
Country
Switzerland
Facility Name
Novartis Investigator Site
City
Basel
Country
Switzerland
Facility Name
Novartis Investigator Site
City
Locarno
Country
Switzerland
Facility Name
Novartis Investigator Site
City
Munchenstein
Country
Switzerland
Facility Name
Novartis Investigator Site
City
Zuerich
Country
Switzerland
Facility Name
Novartis Investigator Site
City
Ankara
Country
Turkey
Facility Name
Novartis Investigator Site
City
Bursa
Country
Turkey
Facility Name
Novartis
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigator Site
City
Izmir
Country
Turkey
Facility Name
Novartis Investigator Site
City
Mersin
Country
Turkey
Facility Name
Novartis Investigator Site
City
Yenisehir
Country
Turkey
Facility Name
Novartis Investigator Site
City
Belfast
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Bexhill-on-Sea
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Blackpool
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Chertsey
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Glasgow
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Leicester
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
London
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Manchester
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Newcastle-upon-Tyne
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Slough
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Swansea
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22206353
Citation
Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.
Results Reference
derived
PubMed Identifier
22003288
Citation
Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.
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
PubMed Identifier
20522841
Citation
Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010 Jun;65(6):473-9. doi: 10.1136/thx.2009.125435.
Results Reference
derived

Learn more about this trial

Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control

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