COPD (Chronic Obstructive Pulmonary Disease) 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 or female (see exclusion criteria 8 below) patients with COPD, aged 40-80 years, with a smoking history of at least 20 pack years (i.e. smokers or ex-smokers). 2. Prior to administration of any study procedures, all subjects must understand and provide written informed consent. Patients must be able to communicate well with the investigator, to understand and comply with the requirements of the study 3. Diagnosis of COPD according to GOLD criteria 4. Body mass index (BMI) must be within the range of 18 to 32 kg/m2. Patients must weigh at least 50 kg to participate in this study. 5. Post-bronchodilator* 40% = FEV1 at screening = 80% of the predicted normal value 6. Post-bronchodilator* FEV1/FVC 120% predicted normal 9. No history of concomitant lung disease such as asthma, carcinoma, active TB or prior thoracic surgery. No requirement for long term oxygen treatment or history of lung reduction surgery. No medical conditions that would interfere with the performance of spirometry or cardiopulmonary exercise testing, serum CPK levels must be in the normal range as measured by point-of-care or lab assay at screening and prior to all protocol specified exercise testing. 10. Male patients must be using a double-barrier local contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit, and refrain from fathering a child in the three (3) months following last study drug administration. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (> 5 mIU/mL) 2. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 2 or during the run-in period 3. Patients requiring oxygen therapy or who experience oxygen desaturation to 430 ms (males) or > 450 ms (females) as assessed by the investigator. Patients who fail the screening ECG (with the exception of machine failures) should not be re-screened. 15. Patients with a history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof 16. Patients who have had treatment with investigational drugs at the time of enrollment, or within 30 days or 5 half-lives prior to screening. 17, 18, 19 Disallowed medications including treatments for COPD and allied conditions and other conditions: (please see protocol for washout times prior to screening and excluded meds, meds allowed if stabilized, and other excluded medications) 20. Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the effect of 2 weeks treatment with inhaled QAB149 (300 mcg) on isotime and peak exercise IC in patients with COPD.;Secondary Objective: • To evaluate the effect of a single dose treatment with inhaled QAB149 (300 mcg) on isotime and peak exercise IC in patients with COPD. • To evaluate the effect of 2 weeks treatment with inhaled QAB149 (300 mcg) on static (resting) IC in patients with COPD. • To evaluate the effect of 2 weeks treatment with inhaled QAB149 (300 mcg) on trough bronchodilatory efficacy FEV1 in patients with COPD. • To evaluate the effect of 2 weeks treatment with inhaled QAB149 (300 mcg) on chronic activity-related breathlessness (baseline and transition dyspnoea indices) in patients with COPD compared to placebo. • To evaluate the effect of 2 weeks treatment with inhaled QAB149 (300 mcg) on dyspnoea (measured with the Borg CR10 Scale®) in patients with COPD compared to placebo.;Primary end point(s): Changes in Forced Expirtory Volume in 1 second, Changes in Forced Vital Capacity, Changes in Inspiratory Capacity, Changes in Functional Residual Capacity, Changes in Total Lung Capacity, Changes in Residual Volume, Changes in Dynamic Inspiratory Capacity. Changes in the above within treatment periods and between treatment periods. | — |
Countries
Germany
Outcome results
None listed