Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00620022
First received: February 8, 2008
Last updated: July 22, 2011
Last verified: July 2011
History of Changes

February 8, 2008
July 22, 2011
April 2008
January 2009   (final data collection date for primary outcome measure)
Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period [ Time Frame: End of each 3 week treatment period (last day of Weeks 3 and 9) ] [ Designated as safety issue: No ]
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.
Exercise endurance time after 3 weeks of treatment.
Complete list of historical versions of study NCT00620022 on ClinicalTrials.gov Archive Site
Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose [ Time Frame: End of each 3 week treatment period (last day of Weeks 3 and 9) ] [ Designated as safety issue: No ]
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.
  • Trough inspiratory capacity after 3 weeks of treatment
  • Trough forced expiratory capacity after 3 weeks treatment
  • Evaluation of effect on pulmonary function test whilst at rest and exercising
  • Effect on Borg Dyspnoea and leg discomfort scales during exercise after 3 weeks treatment
  • Effect on patient activity as measured using an actigraphy device after 3 weeks of treatment
Not Provided
Not Provided
 
The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
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)

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Indacaterol 300 μg
    Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
  • Drug: Placebo
    Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
  • Experimental: Indacaterol 300 μg followed by placebo
    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.
    Interventions:
    • Drug: Indacaterol 300 μg
    • Drug: Placebo
  • Experimental: Placebo followed by indacaterol 300 μg
    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.
    Interventions:
    • Drug: Indacaterol 300 μg
    • Drug: Placebo
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. Epub 2011 Apr 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
January 2009
January 2009   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Denmark,   Italy,   Spain
 
NCT00620022
CQAB149B2311
No
External Affairs, Novartis
Novartis
Not Provided
Study Chair: Novartis Pharma Novartis Pharmaceuticals
Novartis
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP