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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

NCT06664619 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 724

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Fp/ABS

Inhalation powder

DRUG

FP

Inhalation powder

DRUG

ABS

Inhalation powder

DRUG

Placebo

Inhalation powder

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D LLC

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Czechia
  • Germany
  • Israel
  • Mexico
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06664619 on ClinicalTrials.gov