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
The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI). Secondary objectives are: * To evaluate the efficacy of Fp/ABS eMDPI administered four times daily * To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks * To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose The planned study…
Conditions studied
Asthma
About this study
The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI). Secondary objectives are: * To evaluate the efficacy of Fp/ABS eMDPI administered four times daily * To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks * To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.
Interventions
- Drug: Fp/ABS — Inhalation powder
- Drug: FP — Inhalation powder
- Drug: ABS — Inhalation powder
- Drug: Placebo — Inhalation powder
Primary outcomes
- Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks (Baseline, Week 4)
- Change from Baseline trough FEV1 at week 4 (Baseline, Week 4)
Eligibility information
Study locations
- Teva Investigational Site 12087, Phoenix, Arizona 85015 United States
- Teva Investigational Site 12144, Phoenix, Arizona 85020 United States
- Teva Investigational Site 12104, Tucson, Arizona 85715 United States
- Teva Investigational Site 12146, Tucson, Arizona 85741 United States
- Teva Investigational Site 12102, Little Rock, Arkansas 72205 United States
- Teva Investigational Site 12154, Encinitas, California 92024-2812 United States
- Teva Investigational Site 12103, Huntington Beach, California 92647 United States
- Teva Investigational Site 12068, La Palma, California 90623 United States
- Teva Investigational Site 12152, Laguna Niguel, California 92677 United States
- Teva Investigational Site 12145, Long Beach, California 90815 United States
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Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.