Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
Study No.001 about Budesonide/Formoterol use in ASthMA sponsored by Agenzia Italiana del
FArmaco (Italian Drug Agency) (AIFA-ASMA-BF-001) The aim of the study is to verify whether
asthma not controlled by low doses inhaled corticosteroids, thus in need for step up therapy,
can be equally controlled by guidelines recommended regular bid treatment with long acting
beta agonist/inhaled corticosteroid (ICS/LABA) combination or the symptom driven use of an
ICS/LABA combination in the absence of maintenance therapy. The study is designed to be able
to evaluate the non inferiority of regular placebo plus prn inhaled budesonide/formoterol
(experimental treatment) versus regular, twice daily 160/4.5 mcg inhaled
budesonide/formoterol combination plus prn inhaled terbutaline (guidelines recommended
treatment).
Phase:
Phase 3
Details
Lead Sponsor:
Università degli Studi di Ferrara
Treatments:
Budesonide Budesonide, Formoterol Fumarate Drug Combination Formoterol Fumarate Terbutaline