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12-week Efficacy of Indacaterol

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Indacaterol 75 μg
Placebo to indacaterol
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 COPD, indacaterol

Eligibility Criteria

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

Inclusion criteria:

  • Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) and:

    • Smoking history of at least 10 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 had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
  • 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
  • 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
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator 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 Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative 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 Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigative Site
  • Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Indacaterol 75 μg

Placebo to indacaterol

Arm Description

Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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 in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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 the Study (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 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.

Secondary Outcome Measures

Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)
An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.

Full Information

First Posted
February 19, 2010
Last Updated
July 22, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01072448
Brief Title
12-week Efficacy of Indacaterol
Official Title
A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Indacaterol in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This 12-week study evaluated the efficacy and safety of indacaterol versus 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
COPD, indacaterol

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 75 μg
Arm Type
Experimental
Arm Description
Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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
Arm Type
Placebo Comparator
Arm Description
Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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 75 μg
Intervention Description
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Intervention Type
Drug
Intervention Name(s)
Placebo to indacaterol
Intervention Description
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (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 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.
Time Frame
24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
Secondary Outcome Measure Information:
Title
Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)
Description
An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.
Time Frame
End of the study (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 chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) and: Smoking history of at least 10 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 had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening 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 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 Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigator Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Novartis Investigator Site
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
Novartis Investigator Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Novartis Investigator Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Novartis Investigator Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Novartis Investigator Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Novartis Investigator Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Novartis Investigator Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Novartis Investigator Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Novartis Investigator Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Novartis Investigator Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novartis Investigator Site
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Novartis Investigative Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Novartis Investigative Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Novartis Investigative Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Novartis Investigator Site
City
Couer D'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Novartis Investigator Site
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Novartis Investigator Site
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Facility Name
Novartis Investigative Site
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Novartis Investigator Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Novartis Investigator Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Novartis Investigative site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Novartis Investigator Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Novartis Investigator Site
City
Metaire
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Novartis Investigative Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Novartis Investigative Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Novartis Investigative Site
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Novartis Investigative Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Novartis Investigative Site
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Novartis Investigative Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Novartis Investigative Site
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Novartis Investigator Site
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63033
Country
United States
Facility Name
Novartis Investigator Site
City
Ozark
State/Province
Missouri
ZIP/Postal Code
65721
Country
United States
Facility Name
Novartis Investigator Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Novartis Investigative Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Novartis Investigator Site
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Novartis Investigator Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Novartis Investigator Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Novartis Investigator Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Novartis Investigator Site
City
Pahrump
State/Province
Nevada
ZIP/Postal Code
89048
Country
United States
Facility Name
Novartis Investigative Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08902
Country
United States
Facility Name
Novartis Investigative Site
City
Ocean
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Novartis Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Novartis Investigative Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Novartis Investigator Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Novartis Investigative Site
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Novartis Investigative Site
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Novartis Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States
Facility Name
Novartis Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Novartis Investigative Site
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Facility Name
Novartis Investigative site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Novartis Investigative Site
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29678
Country
United States
Facility Name
Novartis Investigative Site
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Novartis Investigator Site
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Novartis Investigator Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76109
Country
United States
Facility Name
Novartis Investigator Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Novartis Investigator Site
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
Facility Name
Novartis Investigative Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novartis Investigator Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23020650
Citation
Gotfried MH, Kerwin EM, Lawrence D, Lassen C, Kramer B. Efficacy of indacaterol 75 mug once-daily on dyspnea and health status: results of two double-blind, placebo-controlled 12-week studies. COPD. 2012 Dec;9(6):629-36. doi: 10.3109/15412555.2012.729623. Epub 2012 Sep 28.
Results Reference
derived
PubMed Identifier
22177371
Citation
Kerwin EM, Gotfried MH, Lawrence D, Lassen C, Kramer B. Efficacy and tolerability of indacaterol 75 mug once daily in patients aged >/=40 years with chronic obstructive pulmonary disease: results from 2 double-blind, placebo-controlled 12-week studies. Clin Ther. 2011 Dec;33(12):1974-84. doi: 10.1016/j.clinthera.2011.11.009.
Results Reference
derived

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12-week Efficacy of Indacaterol

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