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

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Indacaterol 300 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620022

CQAB149B2311

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

Indacaterol 300 μg followed by placebo

Experimental group

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.

Treatment:

Drug: Placebo

Drug: Indacaterol 300 μg

Placebo followed by indacaterol 300 μg

Experimental group

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.

Treatment:

Drug: Placebo

Drug: Indacaterol 300 μg