Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD) (INSIST)
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- CTRI/2009/091/000082
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1084
1) Adults aged ≥40 years
2) Diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2007) and:
Smoking history of at least 10 pack years
Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value at screening (Visit 2).
Post-bronchodilator FEV1/FVC < 70% at screening
1) Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
2) Patients requiring long-term oxygen therapy (>15 h a day) for chronic hypoxemia
3) Patients who have had a respiratory tract infection within 6 weeks prior to screening
4) Patients with concomitant pulmonary disease
5) Patients with a history of asthma
6) Patients with diabetes Type I or uncontrolled diabetes Type II
7) Any patient with lung cancer or a history of lung cancer
8) Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
9) Patients with a history of long QT syndrome or whose QTc interval (Fridericia's) measured at screening is prolonged
10) Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
11) Patients unable to successfully use a dry powder inhaler device, or perform spirometry measurements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 12 hr Area Under the Curve (AUC) forced expiratory volume in 1 second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Timepoint:
- Secondary Outcome Measures
Name Time Method Change from baseline to 24 hr post-dose of (trough) forced expiratory volume in 1 second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Timepoint: