Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

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Novartis

Status and phase

Completed
Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

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

  • Smoking history of at least 10 pack-years.
  • Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted normal value.
  • 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

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: Tiotropium 18 μg
Drug: Placebo
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: Tiotropium 18 μg
Drug: Placebo
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: Tiotropium 18 μg
Drug: Placebo

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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