A Multicenter, Randomized, Double-blind, Single-dose Study to Assess the Effect of the QAB149 and NVA237 Combination Versus QAB149 Alone on Inspiratory Capacity in Patients With Moderate or Severe COPD.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Inspiratory Capacity (IC) Peak Value
Study Overview
Brief Summary
The study purpose is to evaluate the effect of QAB149
- NVA237 vs. QAB149 on static lung hyperinflation.
Detailed Description
This is a multicenter, randomized, double-blinded, single-dose, cross-over, placebo-controlled study. The primary endpoint was chosen to demonstrate the superiority of a single-dose of the combined inhalation vs. the mono inhalation regarding the Inspiratory Capacity (IC) peak value. A total of 78 patients will be randomized to complete two visits with two single doses of treatment. Patients will be randomized in a cross-over manner. Treatment visits will be separated by a study medication wash-out period.Treatments will be administered in a blinded fashion.
The patients will be male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >10-pack years history of smoking, FEV1 <80% and ≥30% of the predicted normal value.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sequence B
Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI
Intervention: QAB149 (Drug)
Sequence A
Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI
Intervention: Placebo (Drug)
Sequence B
Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI
Intervention: NVA237 (Drug)
Sequence A
Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI
Intervention: QAB149 (Drug)
Outcomes
Primary Outcomes
Inspiratory Capacity (IC) Peak Value
Time Frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).
Secondary Outcomes
- Forced Expiratory Volume in One Second (FEV1)(Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours)
- Forced Volume Capacity (FVC)(Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours)
- Airway Resistance (Raw)(Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours)
- Total Lung Capacity (TLC)(Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours)
- Inspiratory Capacity (IC)(within 4h after dosing)