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

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fp/ABS — DRUG
  Inhalation powder
• FP — DRUG
  Inhalation powder
• ABS — DRUG
  Inhalation powder
• Placebo — DRUG
  Inhalation powder

Study Details

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.

Key Dates

Start date

Dec 12, 2024

Status verified

May 2026

Primary completion

Sep 19, 2026

Completion

Sep 19, 2026

Study Design

Enrollment

724 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Fp/ABS eMDPI
  Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module
• Active Comparator: Fp eMDPI
  Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)
• Active Comparator: ABS eMDPI
  Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)
• Placebo Comparator: Placebo eMDPI

Primary Outcome Measure

Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks [ Time Frame: Baseline, Week 4 ]

Central Contacts

• Teva U.S. Medical Information
  1-888-483-8279
  [email protected]

Locations (85)

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