Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Indacaterol 150 μg; Drug: Tiotropium 18 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00999908

CQAB149BIT01

2009-013763-19 (EudraCT Number)

Details and patient eligibility

About

This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.

Enrollment: 54 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:

  1. Smoking history of at least 10 pack-years.
  2. Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted normal value.
  3. Post-bronchodilator FEV1/Force vital capacity (FVC) < 0.7.

Exclusion criteria

• Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment 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 alpha-1-antitrypsin deficiency.
• Patients with contraindications for tiotropium treatment.
• Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.

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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54 participants in 3 patient groups

Indacaterol 150 μg-tiotropium 18 μg-placebo

Experimental group

Description:

Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol 150 μg

Drug: Placebo

Drug: Tiotropium 18 μg

Tiotropium 18 μg-placebo-indacaterol 150 μg

Experimental group

Description:

Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol 150 μg

Drug: Placebo

Drug: Tiotropium 18 μg

Placebo-indacaterol 150 μg-tiotropium 18 μg

Experimental group

Description:

Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol 150 μg

Drug: Placebo

Drug: Tiotropium 18 μg