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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
860
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
Ospedale regionale Umberto I, Unità Operativa di Allergologia
Ancona, AN, Italy
Fondazione S. Maugeri - IRCCS -dipartimento di Pneumologia riabilitativa
Cassano delle Murge, BA, Italy
Dipartimento di Scienze Mediche-Unità Operativa di Pneumologia
Benevento, BN, Italy
Policlinico Sant'Orsola Malpighi, Unità Operativa di Pneumologia
Bologna, BO, Italy
Università degli Studi di Catania, Unità operativa di Pneumologia
Catania, CT, Italy
comparison between groups of the relative risk for treatment failure
Time frame: 52 weeks
number of treatment failures
Time frame: 52 weeks
time to first treatment failure
Time frame: 52 weeks
differences between groups of lung function parameters, quality of life, symptoms score, use of as needed medication, adverse events
Time frame: 52 weeks
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Università Magna Grecia Catanzaro, unità operativa di Pneumologia
Catanzaro, CZ, Italy
Ospedale Morgagni Pierantoni, azienda Ospedaliera di Forlì, Unitaà operativa di Pneumologia
Forlì, FC, Italy
UNIVERSITà DEGLI STUDI DI FERRARA, CLINICA DI MALATTIE DELL'APPARATO RESPIRATORIO
Ferrara, FE, Italy
Università degli studi di Foggia, ospedale pneumologico D'Avanzo, unità operativa di malattie dell'apparato respiratorio
Foggia, FG, Italy
Ospadale San Carlo Borromeo - Unità operativa di Pneumologia
Milan, MI, Italy
...and 21 more locations