Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00999908
First received: October 21, 2009
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Indacaterol 150 μg
Drug: Tiotropium 18 μg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment [ Time Frame: 4 hour period following inhalation of study treatment ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 54
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indacaterol 150 μg-tiotropium 18 μg-placebo
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.
Drug: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Experimental: Tiotropium 18 μg-placebo-indacaterol 150 μg
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.
Drug: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Experimental: Placebo-indacaterol 150 μg-tiotropium 18 μg
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.
Drug: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999908

Locations
Italy
Novartis Investigative Site
Bergamo, Italy
Novartis Investigative Site
Brescia, Italy
Novartis Investigative Site
Cava De' Tirreni, Italy
Novartis Investigative Site
Genova, Italy
Novartis Investigative Site
Milano, Italy
Novartis Investigative Site
Orbassano, Italy
Novartis Investigative Site
Pavia, Italy
Novartis Investigative Site
Reggio Emilia, Italy
Novartis Investigative Site
Sesto San Giovanni, Italy
Novartis Investigative Site
Treviso, Italy
Novartis Investigative Site
Verona, Italy
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00999908     History of Changes
Other Study ID Numbers: CQAB149BIT01, 2009-013763-19
Study First Received: October 21, 2009
Results First Received: July 22, 2011
Last Updated: August 25, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Novartis:
COPD
indacaterol
tiotropium

Additional relevant MeSH terms:
Respiratory Aspiration
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014