Mild to severe COPD MedDRA version: 8.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: indacaterol
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol
CAS Number: 435273-74-8
Current Sponsor code: QAB149
Concentration
Sponsors
NovartisPharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and post-menopausal female adults aged 40-80 years inclusive. 2. Patients with a clinical diagnosis of COPD according to the GOLD Guidelines (2005) 3. Smoking history of at least 10 pack years (i.e. smokers or ex-smokers). 4. Post-bronchodilator FEV1 at screening = 40% of the predicted normal value and = 1.0 L. 5. Post-bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. COPD exacerbations within 6 weeks prior to dosing 2. Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery. 3. Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry. 4. Any other medical condition that in the opinion of the Investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease. 5. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the responsiveness and variability of Mean Maximal Change in percent predicted FEV1 from baseline with Mean Maximal Change in IC from baseline following single doses of indacaterol and matched indacaterol placebo with two doses (b.i.d. regimen) of formoterol as an active control;Secondary Objective: •Comparison of percent predicted FEV1 time course change for indacaterol, formoterol and matched indacaterol placebo. •Comparison of mean maximal change in IC time course change for indacaterol, formoterol and matched indacaterol placebo. ;Primary end point(s): Time-course of FEV1 and IC compared to placebo. | — |
Countries
Denmark, Germany, United Kingdom
Outcome results
None listed