At a glance
ClinicalIndex Comparison Record- ✓Age 18–75 years
- ✓Documented physician diagnosis of asthma for ≥12 months
- ✓On ICS/LABA combination for ≥3 months at stable medium or high ICS dose for ≥1 month
- ✓Pre-bronchodilator FEV1 <80% predicted
- ✕Tobacco smoking or inhalation within 6 months
- ✕Asthma exacerbation requiring systemic steroids, hospitalization, or ER visit within 6 weeks
- ✕Narrow-angle glaucoma, symptomatic BPH, bladder-neck obstruction, severe renal impairment, or urinary retention
- ✕Respiratory tract infection or asthma worsening within 4 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Double-dummy, Active-controlled, 3-period Complete Cross-over Study to Assess the Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma
In Brief
A Phase 2 clinical trial evaluating QVM149 150/50/80 μg o.d., QVM149 150/50/160 μg o.d., and 1 other intervention for Asthma. Completed, enrolled 116 participants across 12 sites in 6 countries.
Detailed Summary
The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this study will complement lung function data obtained in the pivotal QVM149 phase 3 program by assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing interval of 24 hours.
Study Details
Timeline
Interventions
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