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The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indacaterol 300 μg
Placebo
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 indacaterol, chronic obstructive pulmonary disease, exercise endurance, moderate to severe chronic obstructive pulmonary disease, COPD

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure.

  • Co-operative outpatients with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the GOLD Guidelines (2006), 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/forced vital capacity (FVC) < 70%.

Exclusion Criteria:

  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential.
  • Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period.
  • Patients requiring oxygen therapy or who experience oxygen desaturation to < 80% during cycle exercise on room air.
  • Patients with a Wmax value < 20 W (as determined by the incremental cycle endurance test) at screening.
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening.
  • Patients with contra-indications of cardiopulmonary exercise testing.
  • Patients with concomitant pulmonary disease.
  • Patients with a history (up to and including the screening visit) 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 the collection of informed consent visit (Visit 1) 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, metered dose inhaler (MDI), or perform spirometry measurements.

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 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 Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Indacaterol 300 μg followed by placebo

Placebo followed by indacaterol 300 μg

Arm Description

Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 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 first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 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

Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period
At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.

Secondary Outcome Measures

Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose
At the end of each 3 week treatment period 60 minutes before inhalation of study drug, IC was measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.

Full Information

First Posted
February 8, 2008
Last Updated
July 22, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00620022
Brief Title
The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official Title
A Phase III Randomized, Double-blind, Placebo-controlled, 2-period Crossover, Multicenter Study to Assess the Effect of Indacaterol (300 μg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compared the effect of indacaterol (300 μg once daily [od]) on exercise endurance with that of placebo in patients with moderate to severe 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
Keywords
indacaterol, chronic obstructive pulmonary disease, exercise endurance, moderate to severe chronic obstructive pulmonary disease, COPD

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 300 μg followed by placebo
Arm Type
Experimental
Arm Description
Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 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 followed by indacaterol 300 μg
Arm Type
Experimental
Arm Description
Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 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 300 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
Intervention Description
Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Primary Outcome Measure Information:
Title
Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period
Description
At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.
Time Frame
End of each 3 week treatment period (last day of Weeks 3 and 9)
Secondary Outcome Measure Information:
Title
Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose
Description
At the end of each 3 week treatment period 60 minutes before inhalation of study drug, IC was measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Time Frame
End of each 3 week treatment period (last day of Weeks 3 and 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure. Co-operative outpatients with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the GOLD Guidelines (2006), 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/forced vital capacity (FVC) < 70%. Exclusion Criteria: Pregnant or nursing (lactating) women. Women of child-bearing potential. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period. Patients requiring oxygen therapy or who experience oxygen desaturation to < 80% during cycle exercise on room air. Patients with a Wmax value < 20 W (as determined by the incremental cycle endurance test) at screening. Patients who have had a respiratory tract infection within 6 weeks prior to screening. Patients with contra-indications of cardiopulmonary exercise testing. Patients with concomitant pulmonary disease. Patients with a history (up to and including the screening visit) 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 the collection of informed consent visit (Visit 1) 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, metered dose inhaler (MDI), 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 Pharma
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigator Site
City
Torrance
State/Province
California
Country
United States
Facility Name
Novartis Investigator Site
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
Novartis Investigator Site
City
Bruxelles
Country
Belgium
Facility Name
Novartis Investigator Site
City
Gembloux
Country
Belgium
Facility Name
Novartis Investigator Site
City
Jette
Country
Belgium
Facility Name
Novartis Investigator Site
City
Liege
Country
Belgium
Facility Name
Novartis Investigator Site
City
Edmonton
Country
Canada
Facility Name
Novartis Investigator Site
City
Kingston
Country
Canada
Facility Name
Novartis Investigator Site
City
Aarhus
Country
Denmark
Facility Name
Novartis Investigative Site
City
Hellerup
Country
Denmark
Facility Name
Novartis Investigator Site
City
Hvidovre
Country
Denmark
Facility Name
Novartis Investigative site
City
Odense
Country
Denmark
Facility Name
Novartis Investigator Site
City
Genova
Country
Italy
Facility Name
Novartis Investigator Site
City
Pisa
Country
Italy
Facility Name
Novartis Investigator Site
City
Verona
Country
Italy
Facility Name
Novartis Investigator Site
City
Alicante
Country
Spain
Facility Name
Novartis Investigator Site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
Country
Spain
Facility Name
Novartis Investigative site
City
Seville
Country
Spain
Facility Name
Novartis Investigator Site
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21498063
Citation
O'Donnell DE, Casaburi R, Vincken W, Puente-Maestu L, Swales J, Lawrence D, Kramer B; INABLE 1 study group. Effect of indacaterol on exercise endurance and lung hyperinflation in COPD. Respir Med. 2011 Jul;105(7):1030-6. doi: 10.1016/j.rmed.2011.03.014. Epub 2011 Apr 16.
Results Reference
derived

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The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

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