Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Registration Number
- NCT00792805
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 563
-
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:
- Smoking history of at least 10 pack years
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Indacaterol 150 μg Indacaterol 150 µg Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Indacaterol 300 μg Indacaterol 300 μg Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Placebo to indacaterol Placebo to indacaterol Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
- Primary Outcome Measures
Name Time Method Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Novartis Investigator Site
🇨🇳Fuzhou, China
Novartis Investigative Site
🇮🇳Trivandrum, India