Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999908
• Other study ID #: CQAB149BIT01
• Secondary ID: 2009-013763-19
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2009
• Last updated: February 16, 2016
• Start date: October 2009
• Est. completion date: March 2010

Study information

• Verified date: February 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol 150 µg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
• Tiotropium 18 µg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
• Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After 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.	4 hour period following inhalation of study treatment	No
Secondary	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	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.	4 hour period following inhalation of study treatment	No
Secondary	Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After 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.	4 hour period following inhalation of study treatment	No