A 12-week Multi-center, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of the Co-administration of NVA237 + Indacaterol Once Daily vs. Indacaterol Once Daily in Patients With Moderate to Severe COPD
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 449
- Locations
- 1
- Primary Endpoint
- Trough Forced Expiratory Volume at 1 Second (FEV1)
Study Overview
Brief Summary
This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
- •Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.70 at screening.
- •Current or ex-smokers who have a smoking history of at least 10 pack years
- •Symptomatic patients according to daily diary data.
Exclusion Criteria
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential unless using adequate contraception.
- •Patients with Type I or uncontrolled Type II diabetes.
- •Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
- •Patients with paroxysmal (e.g. intermittent) atrial fibrillation
- •Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)
- •Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
NVA237 + indacaterol
Intervention: NVA237 50 µg and indacaterol 150 µg (Drug)
Placebo to NVA237 + indacaterol
Intervention: Placebo to NVA237 and indacaterol 150 µg (Drug)
Outcomes
Primary Outcomes
Trough Forced Expiratory Volume at 1 Second (FEV1)
Time Frame: 12 weeks
Centralized spirometry according to internationally accepted standards was used. The model contained treatment, baseline smoking status and baseline inhaled corticosteroid (ICS) use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in region as a random effect. If trough FEV1 was missing at week 12, the latest non-missing pre-dose trough FEV1 (the mean of 45 and 15 min pre-dose measurements) from day 29, 57 or 84) was carried forward. These measurements had to have been taken before the next dose of study medication. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
Secondary Outcomes
- FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose(12 weeks)
- Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks(12 weeks)
- FEV1 at Individual Time-points(Day 1, Day 29, Day 57 and Days 84/85)
- Forced Vital Capacity (FVC) at Individual Time-points(Day 1, Day 29, Day 57 and Days 84/85)
- Inspiratory Capacity (IC) at Individual Time-points(Day 1, Days 84/85)
- Change From Baseline in Mean Daily Number of Puffs of Rescue Medication(Baseline, 12 weeks)
- Transitional Dyspnea Index (TDI) Focal Score(baseline, 12 weeks)
- Change From Baseline in Mean Daily Total and Individual Symptom Scores(Baseline, 12 weeks)
- Number of Participants With Adverse Events and Serious Adverse Events(12 weeks)