Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Phase III, 26-week Multicenter Randomized Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.
Status | Completed |
Enrollment | 563 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Adults aged = 40 years - Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and: 1. Smoking history of at least 10 pack years 2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and = 30% of the predicted normal value 3. Post-bronchodilator FEV1/FVC (forced vital capacity) < 70% Exclusion Criteria: - Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period - Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia - Patients who have had a respiratory tract infection within 6 weeks prior to screening - Patients with concomitant pulmonary disease - Patients with a history of asthma - Patients with diabetes Type I or uncontrolled diabetes Type II - Any patient with lung cancer or a history of lung cancer - Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time - Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening is prolonged - Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period - Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements Other protocol-defined inclusion/exclusion criteria applied to the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Novartis Investigative Site | Adelaide | |
Australia | Novartis Investigative Site | Clayton | |
Australia | Novartis Investigative Site | Daw Park | |
China | Novartis Investigative Site | Beijing | |
China | Novartis Investigative Site | Changsha | |
China | Novartis Investigative Site | Chongqing | |
China | Novartis Investigator Site | Fuzhou | |
China | Novartis Investigative Site | Guang Zhou | |
China | Novartis Investigative Site | Shandong | |
China | Novartis Investigative Site | Shanghai | |
China | Novartis Investigative Site | Shenyang | |
China | Novartis Investigative Site | Shijiazhuang | |
China | Novartis Investigative Site | Xi'an | |
India | Novartis Investigative Site | Bangalore | |
India | Novartis Investigative Site | Trivandrum |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Australia, China, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates. | Week 12 + 1 day, Day 85 | No |
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