Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female adults aged =40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure 2.Patients diagnosed with COPD at age 40 and over 3.Co-operative outpatients with a diagnosis of COPD (severe as classified by the GOLD Guidelines, 2007 and including: Smoking history of at least 10 pack years, both current and ex-smokers are eligible Post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients who have received systemic corticosteroids and/or antibiotics 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 (Fredricia’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 |
|---|---|
| Main Objective: To demonstrate superiority of 150 µg o.d. of indacaterol versus tiotropium 18 µg o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment. Trough is defined as the mean of FEV1 measurements at 23h 10 min and 23h 45 min post morning dose.;Secondary Objective: To demonstrate that indacaterol 150 µg o.d, is non inferior to tiotropium 18 µg o.d. with regard to the rate of exacerbations during 52 weeks of treatment.;Primary end point(s): To demonstrate superiority of 150 µg o.d. of indacaterol versus tiotropium 18 µg o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment Trough is defined as the mean of FEV1 measurements at 23h 10 min and 23h 45 min post morning dose. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed