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
Verified date | February 2016 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Italy,
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 |
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