Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): budesonide/formoterol combination (PRN); budesonide/formoterol combination; placebo; terbutaline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): budesonide/formoterol combination 160/4.5 mcg 1 inhalation used as needed for a period of 52 weeks; budesonide/formoterol 160/4.5 mcg 1 inhalation bid; bid inhaled placebo; as needed terbutaline 500 mcg for a period of 52 weeks
Other intervention name(s): budesonide/formoterol combination
Intervention MeSH terms: Budesonide; Terbutaline; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Adult; Asthma; Bronchodilator Agents; Budesonide; Double-Blind Method; Drug Therapy, Combination; Ethanolamines; Female; Forced Expiratory Volume; Humans; Male; Terbutaline