At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
48-week, Multicentre, Multinational, Randomized, Double-blind, 2-arm Parallel Group, Comparing the Efficacy of FOSTER for Maintenance & Reliever Versus Fixed-dose FOSTER for Maintenance + Salbutamol as Reliever in Asthmatics ≥ 18 Years of Age
In Brief
A Phase 3 clinical trial evaluating Salbutamol and Beclomethasone dipropionate + Formoterol for Asthma. Completed, enrolled 1,714 participants across 206 sites in 14 countries.
Detailed Summary
Primary objective: The primary objective of the study was to compare the efficacy of Maintenance and Reliever Therapy (MART) with Foster® 100/6 μg (one inhalation bid) plus additional inhalations as needed, with the standard treatment of Foster® 100/6 μg (one inhalation bid) plus salbutamol 100 μg (Ventolin ®) additional inhalations as needed in not fully controlled asthmatic patients. Secondary objectives: The secondary objectives of the study were: * to evaluate the effect of treatments on lung function parameters and on other clinical outcome measures, and * to assess the safety and the tolerability of Foster® as MART.
Study Details
Timeline
Interventions
Administered via a pressurized metered-dose inhaler
Administered via a pressurized metered-dose inhaler