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

• ClinicalTrials.gov Identifier: NCT00620022
• Recruitment Status: Completed
• First Posted: February 21, 2008
• Results First Posted: August 17, 2011
• Last Update Posted: August 17, 2011
• Sponsor: Novartis
• Information provided by: Novartis

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Indacaterol 300 μg; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: April 2008
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
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.	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: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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) ]
   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 :

1. 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) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Novartis Investigator Site

Torrance, California, United States

United States, New Hampshire

Novartis Investigator Site

Lebanon, New Hampshire, United States

Belgium

Novartis Investigator Site

Bruxelles, Belgium

Novartis Investigator Site

Gembloux, Belgium

Novartis Investigator Site

Jette, Belgium

Novartis Investigator Site

Liege, Belgium

Canada

Novartis Investigator Site

Edmonton, Canada

Novartis Investigator Site

Kingston, Canada

Denmark

Novartis Investigator Site

Aarhus, Denmark

Novartis Investigative Site

Hellerup, Denmark

Novartis Investigator Site

Hvidovre, Denmark

Novartis Investigative site

Odense, Denmark

Italy

Novartis Investigator Site

Genova, Italy

Novartis Investigator Site

Pisa, Italy

Novartis Investigator Site

Verona, Italy

Spain

Novartis Investigator Site

Alicante, Spain

Novartis Investigator Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative site

Seville, Spain

Novartis Investigator Site

Zaragoza, Spain

Sponsors and Collaborators

Novartis

Investigators

• Study Chair: Novartis Pharma; Novartis Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: External Affairs, Novartis
• ClinicalTrials.gov Identifier: NCT00620022
• Other Study ID Numbers: CQAB149B2311
• First Posted: February 21, 2008
• Results First Posted: August 17, 2011
• Last Update Posted: August 17, 2011
• Last Verified: July 2011

Keywords provided by Novartis:

indacaterol; chronic obstructive pulmonary disease; exercise endurance; moderate to severe chronic obstructive pulmonary disease; COPD

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases