This clinical trial compared the efficacy and safety of the combination inhaled drug of fluticasone/salmeterol versus fluticasone and salmeterol given concurrently in asthma patients

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: Fluticasone/salmeterol HFA pMDI: 2 puffs b.i.d for 12 weeks Control Intervention1: Fluticasone HFA pMDI + salmeterol CFC pMDI both taken concurrently: 2 puffs b.i.d from each inhaler for 12 weeks CONDITION: Asthma PRIMARY OUTCOME: Mean morning PEFR‐‐‐‐‐‐Timepoint: Baseline and 3, 6, 9 and 12 weeks after randomization SECONDARY OUTCOME: ? FEV1 ; ? Forced expiratory flow at 25% and 75%; ? Interference of asthma symptoms with daytime activities and sleep.; ? Number of administrations of rescue medication.; ? Overall assessment of efficacy by investigator.; ‐‐‐‐‐‐Timepoint: Baseline and 3, 6, 9 and 12 weeks after randomization INCLUSION CRITERIA: INCLUSION CRITERIA: Suitable subjects were of either sex; aged 18 to 65 years with a confirmed diagnosis of mild to moderate asthma and using ICS less than 400 & 800 mcg of beclometasone dipropionate (BDP) or equivalent per day for at least 4 weeks prior to the screening visit. Symptomatic subjects also demonstrated a prebronchodilator forced expiratory volume in one second (FEV1) greater than 60% and less than 90% of the predicted normal value when not taking short‐acting bronchodilator medication, and were able to demonstrate a greater than 12% improvement in FEV1 within 15‐30 minutes after inhalation of salbutamol unless reversibility had been documented in the previous 12 months. All subjects gave written, informed consent and were, in the opinion of the investigator, able to comply with the requirements of the protocol.
Epistemonikos ID: 9aaefbacb0ec9985e5fcab3bb7026c59b95b2e01
First added on: Aug 22, 2024