chronic obstructive pulmonary disease (COPD) MedDRA version: 17.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adults aged =40 years. 2. Patients who have signed an Informed Consent Form prior to initiation of any study-related procedure. 3. Patients with stable COPD according to the current GOLD guidelines (GOLD 2013). 4. Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who has not smoked for = 6 months at screening. 5. Patients with airflow limitation indicated by a post-bronchodilator FEV1 =40% and =65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. Patients with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof ? anticholinergics ? long and short acting beta2 agonists ? sympathomimetic amines ? lactose or any of the other excipients 2. Patients with a history of long QT syndrome or whose QTc calculated at run-in (Fredericia method) is prolonged (>450ms for males and >470ms for females).These patients should not be re-enrolled. 3. Patients who have a clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator would be at potential risk if enrolled into the study. These patients should not be re-screened. 4. Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at baseline and screening visits, with a resting ventricular rate 8.0% at Visit 2. 6. Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR 5 mIU/ml)). 16. Women of child-bearing potential, defined as all women physiologically capab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: ? To demonstrate that QVA149 (110/50 µg q.d.) is superior compared to placebo on peak inspiratory capacity (IC) after 21 days of treatment in patients with moderate to severe COPD. Co-primary objective: ? To evaluate whether QVA149 is superior to placebo with respect to average physical activity level as defined by average daily activity-related energy consumption [Kcal/day].;Secondary Objective: ? To evaluate the effects QVA149 compared to placebo on the average number of steps per day ? To evaluate the effects QVA149 compared to placebo on the duration of at least moderate activity per day ? To demonstrate that QVA149 (110/50 µg o.d.) is superior compared to placebo on peak IC on day 1 ? To demonstrate that QVA149 (110/50 µg o.d.) is superior compared to placebo on trough IC after 21 days of treatment ? To demonstrate that QVA149 (110/50 µg o.d.) is superior compared to placebo on peak FEV1 on day 1 ? To demonstrate that QVA149 (110/50 µg o.d.) is superior compared to placebo on trough FEV1 after 21 days of treatment;Primary end point(s): To demonstrate that QVA149 (110/50 µg q.d.) is superior compared to placebo on peak inspiratory capacity (IC) after 21 days of treatment in patients with moderate to severe COPD. To evaluate whether QVA149 is superior to placebo with respect to average physical activity level as defined by average daily activity-related energy consumption [Kcal/day].;Timepoint(s) of evaluation of this end point: 8 to 10 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the effects QVA149 compared to placebo on the average number of steps per day ? To evaluate the effects QVA149 compared to placebo on the duration of at least moderate activity per day ? To demonstrate that QVA149 (110/50 µg o.d.) is superior compared to placebo on peak IC on day 1 ? To demonstrate that QVA149 (110/50 µg o.d.) is superior compared to placebo on trough IC after 21 days of treatment ? To demonstrate that QVA149 (110/50 µg o.d.) is superior compared to placebo on peak FEV1 on day 1 ? To demonstrate that QVA149 (110/50 µg o.d.) is superior compared to placebo on trough FEV1 after 21 days of treatment;Timepoint(s) of evaluation of this end point: 8 to 10 weeks | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed