Randomized, open-label, parallel-group study for comparing efficacy of budesonide/formoterol (160/4.5 mcg) fixed dosing (4 inhalations daily) and adjustable maintenance dosing (2 to 8 inhalations daily) in poorly controlled adult asthma patients

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: Treatment with budesonide/formoterol (160/4.5 mcg) for 12 weeks, one to four inhalations, twice daily, dose is adjusted every 2 weeks if necessary Treatment with budesonide/formoterol (160/4.5 mcg) for 12 weeks, two inhalations, twice daily, fixed dosing CONDITION: Bronchial asthma PRIMARY OUTCOME: Change of the Asthma Control Questionnaire score SECONDARY OUTCOME: ‐ Respiratory function (FEV1); ‐ Total dose of budesonide/formoterol; ‐ Mini Asthma Quality of Life Questionnaire score; ‐ Number of adverse event INCLUSION CRITERIA: ‐ Patients with FEV1>= 60% predicted ‐ Patients who have received ICS for at least 4 weeks before enrollment ‐ Patients with average ACQ score >= 0.75
Epistemonikos ID: f5a1b03c99813773090f3c891679cc32bed05c24
First added on: Aug 22, 2024