A 12 Week Treatment, Multi-Center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 µg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 µg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler

Novartis Healthcare Pvt Ltd9 sites in 1 country1,084 target enrollmentStarted: January 15, 2009Last updated: September 23, 2014

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor
Enrollment: 1,084
Locations: 9
Primary Endpoint: 12 hr Area Under the Curve (AUC) forced expiratory volume in 1 second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Number of patients to be recruited from India is 140.

•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.

•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.

12 hr Area Under the Curve (AUC) forced expiratory volume in 1 second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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 ]

Sponsor

Novartis Healthcare Pvt Ltd

Sponsor Class

Pharmaceutical industry-Global

Loading locations...