NCT00849095

Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 860 (actual)
• Sponsor: Università degli Studi di Ferrara · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Asthma is a problem worldwide, with an estimated 300 million affected individuals.There is evidence that asthma prevalence has been increasing in the last decades in some countries, including Italy. Analyses of the cost of asthma lead to conclude that the burden of the disease depend on the extent to which exacerbations are avoided since emergency treatment is more expensive than regular treatment. Based on solid evidence, international guidelines recommend regular treatment with low dose ICS for mild persistent asthma and treatment with combination therapy \[low dose ICS plus long-acting beta2-agonists (LABA)\] for patients with asthma not controlled by low doses ICS alone. Recent studies have undermined the axiom that treatment with ICS must be regular to achieve and maintain asthma control, as equivalent control has been obtained either with prn use of an inhaled combination of a short acting beta2 agonist (SABA) and an ICS, or with a short course of 10 days high dose ICS at the start of exacerbations. In moderate-severe asthma regularly treated with inhaled ICS/LABA combination, the symptom-driven use of the same inhaled ICS/LABA combination as reliever is superior to the symptom-driven use of SABA or LABA alone.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	budesonide/formoterol combination (PRN)	budesonide/formoterol combination 160/4.5 mcg 1 inhalation used as needed for a period of 52 weeks
DRUG	budesonide/formoterol combination	budesonide/formoterol 160/4.5 mcg 1 inhalation bid
DRUG	placebo	bid inhaled placebo
DRUG	terbutaline	as needed terbutaline 500 mcg for a period of 52 weeks

Timeline

• Start date: 2009-04-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2009-02-23
• Last updated: 2014-05-30

Locations

31 sites across 1 country: Italy