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Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indacaterol 150 μg capsules
Indacaterol 300 μg capsules
Placebo capsules
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 COPD, chronic obstructive pulmonary disease, indacaterol, long acting β2-agonist

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 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 vital capacity) < 70%.

Exclusion Criteria:

  • Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization.
  • Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia.
  • Patients who have 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.
  • Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time.
  • Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged.
  • Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
  • Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.

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

Sites / Locations

  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigative Center
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Indacaterol 150 µg

Indacaterol 300 µg

Placebo

Arm Description

Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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) 24 Hours Post-dose at the End of Treatment (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 during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.

Secondary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2
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 Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
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 Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8
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 Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.

Full Information

First Posted
November 17, 2008
Last Updated
July 22, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00794157
Brief Title
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A 12-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily [od]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.

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
COPD, chronic obstructive pulmonary disease, 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
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 150 µg
Arm Type
Experimental
Arm Description
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 300 µg
Arm Type
Experimental
Arm Description
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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
Arm Type
Placebo Comparator
Arm Description
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 150 μg capsules
Intervention Description
Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Intervention Type
Drug
Intervention Name(s)
Indacaterol 300 μg capsules
Intervention Description
Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Intervention Type
Drug
Intervention Name(s)
Placebo capsules
Intervention Description
Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (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 during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Time Frame
End of treatment (Week 12 + 1 day, Day 85)
Secondary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2
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 Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Time Frame
After Week 2 (Day 15)
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
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 Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Time Frame
After Week 4 (Day 29)
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8
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 Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Time Frame
After Week 8 (Day 57)
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)
Description
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Time Frame
Prior to last dose at Week 12 (Day 84)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 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 vital capacity) < 70%. Exclusion Criteria: Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization. Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia. Patients who have 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. Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time. Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged. Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period. Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements. Other protocol-defined inclusion/exclusion criteria applied to the study.
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 Investigator Site
City
Hong Kong
Country
Hong Kong
Facility Name
Novartis Investigator Site
City
New Territories
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Ahmedabad
Country
India
Facility Name
Novartis Investigator Site
City
Bangalore
Country
India
Facility Name
Novartis Investigative Site
City
Coimbatore
Country
India
Facility Name
Novartis Investigator Site
City
Coimbatore
Country
India
Facility Name
Novartis Investigator Site
City
India
Country
India
Facility Name
Novartis Investigative Site
City
Mumbai
Country
India
Facility Name
Novartis Investigative Center
City
Panjim
Country
India
Facility Name
Novartis Investigative Site
City
Asahikawa
Country
Japan
Facility Name
Novartis Investigative Site
City
Bunkyo-ku
Country
Japan
Facility Name
Novartis Investigator Site
City
Gifu
Country
Japan
Facility Name
Novartis Investigator Site
City
Himeji
Country
Japan
Facility Name
Novartis Investigator Site
City
Hiroshima
Country
Japan
Facility Name
Novartis Investigator Site
City
Iwata
Country
Japan
Facility Name
Novartis Investigator Site
City
Kanazawa
Country
Japan
Facility Name
Novartis Investigative site
City
Kawasaki
Country
Japan
Facility Name
Novartis Investigator Site
City
Kishiwada
Country
Japan
Facility Name
Novartis Investigator Site
City
Kitakyushu
Country
Japan
Facility Name
Novartis Investigator Site
City
Kochi
Country
Japan
Facility Name
Novartis Investigator Site
City
Koga
Country
Japan
Facility Name
Novartis Investigative Site
City
Kurume
Country
Japan
Facility Name
Novartis Investigator Site
City
Kyoto
Country
Japan
Facility Name
Novartis Investigative Site
City
Maebashi
Country
Japan
Facility Name
Novartis Investigator Site
City
Matsusaka-City
Country
Japan
Facility Name
Novartis Investigative Site
City
Morioka
Country
Japan
Facility Name
Novartis Investigator Site
City
Nagaoka-City
Country
Japan
Facility Name
Novartis Investigator Site
City
Nagoya
Country
Japan
Facility Name
Novartis Investigative Site
City
Noda
Country
Japan
Facility Name
Novartis Investigative Site
City
Obihiro
Country
Japan
Facility Name
Novartis Investigator Site
City
Sakai
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo
Country
Japan
Facility Name
Novartis Investigator Site
City
Sendai
Country
Japan
Facility Name
Novartis Investigator Site
City
Seto
Country
Japan
Facility Name
Novartis Investigator Site
City
Tenri
Country
Japan
Facility Name
Novartis Investigative site
City
Tokyo
Country
Japan
Facility Name
Novartis Investigator Site
City
Toyonaka
Country
Japan
Facility Name
Novartis Investigator Site
City
Ube
Country
Japan
Facility Name
Novartis Investigator Site
City
Wakayama
Country
Japan
Facility Name
Novartis Investigator Site
City
Yabu
Country
Japan
Facility Name
Novartis Investigator Site
City
Yanagawa
Country
Japan
Facility Name
Novartis Investigator Site
City
Yokkaichi
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
Country
Japan
Facility Name
Novartis Investigator Site
City
Daegu
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Jung-gu
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Kangwon-Do
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Pusan
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigator Site
City
Singapore
Country
Singapore
Facility Name
Novartis Investigator Site
City
Chia-Yi
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Hsintien
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Kaohsiung
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Keelung
Country
Taiwan
Facility Name
Novartis Investigative Site
City
LinKou
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Taichung
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Taipei County
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
Country
Taiwan
Facility Name
Novartis Investigator Site
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23040786
Citation
To Y, Kinoshita M, Lee SH, Hang LW, Ichinose M, Fukuchi Y, Kitawaki T, Okino N, Prasad N, Lawrence D, Kramer B. Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population. Respir Med. 2012 Dec;106(12):1715-21. doi: 10.1016/j.rmed.2012.09.002. Epub 2012 Oct 5.
Results Reference
derived

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Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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