drugset / Trial / NCT00861926

Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)

NCT00861926

Phase 3 Completed 1714 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2009-03-20
Primary completion
2010-12-07
Completion
2010-12-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Beclomethasone Small molecule 100 ug Inhaled
Subject Formoterol Other / unclassified 6 ug Inhaled
Comparator Salbutamol Unknown 100 ug Inhaled

Indications