Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Intervention1: Indacaterol: 150 µ
g
Control Intervention1: Salmeterol: 50 µ
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 Post-bronchodilator FEV1/FVC
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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: | — |
Countries
India
Contacts
Public ContactDr. Kamala Rai
Outcome results
None listed