Skip to main content
OpenTrials
Completed

NCT Number: NCT00999908

Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Bergamo, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indacaterol 150 μg

Drug

Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Tiotropium 18 μg

Drug

Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Placebo

Drug

Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Primary outcomes

  1. Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment

    Time frame: 4 hour period following inhalation of study treatment

    During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.

Secondary outcomes

  1. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment

    Time frame: 4 hour period following inhalation of study treatment

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.

  2. Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment

    Time frame: 4 hour period following inhalation of study treatment

    FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Multicenter, Randomized, Blinded, Placebo-controlled, Crossover, Single-dose Study to Assess the Effect of Indacaterol (150 μg) Versus Tiotropium (18 μg) on Inspiratory Capacity in Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 22, 2009
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.