4-Week Double-Blind Trial of Fluticasone PropionateAlbuterol Sulfate Inhalers Compared to Individual Components or Placebo in Asthma Participants 12 Years and Older

What this Trial Is About

Researchers are evaluating the efficacy and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered via a multidose dry powder inhaler with an electronic module in people aged 12 years and older who have asthma. The study is designed as a randomized, double-blind, placebo-controlled trial and aims to assess lung function improvements, safety, tolerability, and drug behavior in the body over a four-week period. Secondary goals include evaluating the combination inhaler administered four times daily and understanding the pharmacokinetics of the inhaler components after a single dose. Participants will be randomly assigned to one of four groups receiving either the combination inhaler FpABS, fluticasone propionate inhaler Fp, albuterol sulfate inhaler ABS, or a placebo inhaler, all with integrated electronic modules. Treatments are inhalation powders administered via dry powder inhalers. The study lasts about 10 weeks per participant, including the treatment period of four weeks and follow-up assessments. The trial includes a prescreening visit as an option before formal enrollment. During the study, participants will have their lung function measured through forced expiratory volume in one second FEV1, asthma control assessed by questionnaires ACQ-6 and ACT, and blood samples taken to analyze drug levels. Safety is monitored by tracking adverse events and tolerability over the treatment period. The main outcomes focus on changes in lung function at baseline and after four weeks of treatment. Participants are expected to attend multiple visits for these assessments throughout the study duration.

A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma