A Study to Compare the Efficacy and Safety of Once Daily QVA149 Versus the Once Daily Concurrent Administration of QAB149 Plus NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 193
- Locations
- 1
- Primary Endpoint
- Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment
Study Overview
Brief Summary
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).
Detailed Description
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female adults aged ≥ 40 yrs
- •Smoking history of at least 10 pack years
- •Diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2010)
- •Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Exclusion Criteria
- •Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
- •Patients with concomitant pulmonary disease
- •Patients with a history of asthma
- •Any patient with lung cancer or a history of lung cancer
- •Patients with a history of certain cardiovascular co-morbid conditions
- •Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
- •Patients in the active phase of a supervised pulmonary rehabilitation program
- •Patients contraindicated for inhaled anticholinergic agents and β2 agonists
- •Other protocol-defined inclusion/exclusion criteria may apply
Arms & Interventions
QVA149
QVA149 plus placebo once daily for 28 days.
Intervention: QVA149 (Drug)
QVA149
QVA149 plus placebo once daily for 28 days.
Intervention: Placebo (Drug)
QAB149 + NVA237
Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
Intervention: NVA237 (Drug)
QAB149 + NVA237
Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
Intervention: QAB149 (Drug)
Outcomes
Primary Outcomes
Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment
Time Frame: Day 29
Spirometry was conducted according to internationally accepted standards. Trough FEV1 is defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings measured at day 29, after 28 days of treatment. Mixed model: Trough FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.
Secondary Outcomes
- Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 1(0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 1)
- Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 28(0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 28)
- Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 28 Post-dose(5 min - 4 hr at Days 1 and 28)
- Time Course of Forced Expiratory Volume in One Second (FEV1) (Pre-dose to 4 Hours Post Dose) on Day 28(-45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28)
- Change From Baseline in the Mean Daily, (Daytime and Nighttime Combined) Number of Puffs of Rescue Medication Used Over 28 Days of Treatment(Baseline and 28 days)
- Change From Baseline in Percentage of Days With 'no Daytime Symptoms' Over 28 Days of Treatment(28 days)