Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)
brief 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.
detailed description
This was a 48-week phase III, double-blind, randomized, 2-arm parallel group study in asthmatic patients (adults of both sexes) not fully controlled under ICS treatment.
The study plan included:
* A pre-screening visit (V0, 3-10 days before V1) to explain the aim of the study, to sign the informed consent form and to prepare patients for V1; * A screening visit (V1, week -2) to assess inclusion/exclusion criteria followed by a 2-week run-in period when the patients received Foster® 100/6μg, one inhalation twice a day plus salbutamol for reliever medication; * A randomization visit (V2, week 0) when patients were allocated to one of the two treatment arms:
A) Foster® 100/6 μg one inhalation bid for maintenance plus additional inhalations as needed; B) Foster® 100/6 μg one inhalation bid for maintenance plus salbutamol as needed.
* And subsequent visits taking place at clinics after 4 (V3), after 12 (V4), after 24 (V5), after 36 (V6) and after 48 weeks (V7) of treatment.
The total study duration per participant was 50 weeks, including the 2-week run-in period, 48-week treatment phase.
Salbutamol was used as a rescue medication.
official title
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