Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A 12-week Treatment, 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 was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily [od]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.
Status | Completed |
Enrollment | 347 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and: 1. Smoking history of at least 20 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 been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization. - 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 or randomization 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 |
---|---|---|---|
Hong Kong | Novartis Investigator Site | Hong Kong | |
Hong Kong | Novartis Investigator Site | New Territories | |
India | Novartis Investigative Site | Ahmedabad | |
India | Novartis Investigator Site | Bangalore | |
India | Novartis Investigative Site | Coimbatore | |
India | Novartis Investigator Site | Coimbatore | |
India | Novartis Investigator Site | India | |
India | Novartis Investigative Site | Mumbai | |
India | Novartis Investigative Center | Panjim | |
Japan | Novartis Investigative Site | Asahikawa | |
Japan | Novartis Investigative Site | Bunkyo-ku | |
Japan | Novartis Investigator Site | Gifu | |
Japan | Novartis Investigator Site | Himeji | |
Japan | Novartis Investigator Site | Hiroshima | |
Japan | Novartis Investigator Site | Iwata | |
Japan | Novartis Investigator Site | Kanazawa | |
Japan | Novartis Investigative site | Kawasaki | |
Japan | Novartis Investigator Site | Kishiwada | |
Japan | Novartis Investigator Site | Kitakyushu | |
Japan | Novartis Investigator Site | Kochi | |
Japan | Novartis Investigator Site | Koga | |
Japan | Novartis Investigative Site | Kurume | |
Japan | Novartis Investigator Site | Kyoto | |
Japan | Novartis Investigative Site | Maebashi | |
Japan | Novartis Investigator Site | Matsusaka-City | |
Japan | Novartis Investigative Site | Morioka | |
Japan | Novartis Investigator Site | Nagaoka-City | |
Japan | Novartis Investigator Site | Nagoya | |
Japan | Novartis Investigative Site | Noda | |
Japan | Novartis Investigative Site | Obihiro | |
Japan | Novartis Investigator Site | Sakai | |
Japan | Novartis Investigative Site | Sapporo | |
Japan | Novartis Investigator Site | Sendai | |
Japan | Novartis Investigator Site | Seto | |
Japan | Novartis Investigator Site | Tenri | |
Japan | Novartis Investigative site | Tokyo | |
Japan | Novartis Investigator Site | Toyonaka | |
Japan | Novartis Investigator Site | Ube | |
Japan | Novartis Investigator Site | Wakayama | |
Japan | Novartis Investigator Site | Yabu | |
Japan | Novartis Investigator Site | Yanagawa | |
Japan | Novartis Investigator Site | Yokkaichi | |
Japan | Novartis Investigative Site | Yokohama | |
Korea, Republic of | Novartis Investigator Site | Daegu | |
Korea, Republic of | Novartis Investigator Site | Jung-gu | |
Korea, Republic of | Novartis Investigative Site | Kangwon-Do | |
Korea, Republic of | Novartis Investigator Site | Pusan | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigator Site | Seoul | |
Singapore | Novartis Investigator Site | Singapore | |
Taiwan | Novartis Investigator Site | Chia-Yi | |
Taiwan | Novartis Investigator Site | Hsintien | |
Taiwan | Novartis Investigator Site | Kaohsiung | |
Taiwan | Novartis Investigative Site | Keelung | |
Taiwan | Novartis Investigative Site | LinKou | |
Taiwan | Novartis Investigative Site | Taichung | |
Taiwan | Novartis Investigator Site | Taichung | |
Taiwan | Novartis Investigative Site | Taipei | |
Taiwan | Novartis Investigator Site | Taipei | |
Taiwan | Novartis Investigator Site | Taipei County |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Hong Kong, India, Japan, Korea, Republic of, Singapore, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (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, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | End of treatment (Week 12 + 1 day, Day 85) | No |
Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2 | 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 Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | After Week 2 (Day 15) | No |
Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4 | 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 Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | After Week 4 (Day 29) | No |
Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8 | 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 Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | After Week 8 (Day 57) | No |
Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | Prior to last dose at Week 12 (Day 84) | No |
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