As Needed Budesonide/Formoterol Combination Versus Regular Budesonide/Formoterol Combination Plus as Needed Terbutaline in Mild-Moderate Persistent Asthma

NCT00849095 Phase 3 COMPLETED

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).

Details

Lead sponsor	Università degli Studi di Ferrara
Phase	Phase 3
Status	COMPLETED
Enrolment	860
Start date	2009-04
Completion	2013-05

Conditions

• Asthma

Interventions

• budesonide/formoterol combination (PRN)
• budesonide/formoterol combination
• placebo
• terbutaline

Primary outcomes

• comparison between groups of the relative risk for treatment failure — 52 weeks

Countries

Italy