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NCT06664619 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.

Recruiting
Registry status
Phase 3
Development phase
724
Enrollment target
20
Study locations

NCT06664619: Recruiting Phase 3 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.

NCT06664619 is a Phase 3 study of Asthma that is actively recruiting participants, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 724 participants, below the 1,561-participant average among 374 other Asthma trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06664619, a Phase 3 study of Asthma, is actively recruiting participants, sponsored by Teva Branded Pharmaceutical Products R&D.

RECRUITING
Registry status
Phase 3
Development phase
724 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Baseline values are averaged on day 1 to get a single value. Area under the effect curve will be calculated using measurements collected between zero and 6 hours after dosing. Baseline-adjusted post-dose FEV1 AUEC0-6h for visits on Day 1 and at Week 4 will be calculated using the trapezoidal rule.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Fp/ABS
  • DRUG FP
  • DRUG ABS

Study Locations (20)

California

  • Teva Investigational Site 12154 - Encinitas
  • Teva Investigational Site 12103 - Huntington Beach
  • Teva Investigational Site 12068 - La Palma
  • Teva Investigational Site 12152 - Laguna Niguel
  • Teva Investigational Site 12145 - Long Beach
  • Teva Investigational Site 12088 - Los Angeles
  • Teva Investigational Site 12094 - Los Angeles
  • Teva Investigational Site 12161 - Northridge
  • Teva Investigational Site 12105 - Oxnard
  • Teva Investigational Site 12101 - Sacramento
  • Teva Investigational Site 12064 - San Jose
  • Teva Investigational Site 12109 - Upland
  • Teva Investigational Site 12070 - Vista
  • Teva Investigational Site 12091 - Walnut Creek

Arizona

  • Teva Investigational Site 12087 - Phoenix
  • Teva Investigational Site 12144 - Phoenix
  • Teva Investigational Site 12104 - Tucson
  • Teva Investigational Site 12146 - Tucson

Arkansas

  • Teva Investigational Site 12102 - Little Rock

Colorado

  • Teva Investigational Site 12142 - Lakewood

Trial Details

FieldValue
Enrollment Target 724 participants
Start Date 2024-12-12
Est. Completion 2026-05-31
Phase Phase 3

What NCT06664619 shows while recruiting

NCT06664619 is an interventional study that assigns participants to a tested intervention. The registered 724 participants enrollment target is mid-sized for trials with a published cap, below the 1,561-participant average among 374 other Asthma trials with a reported enrollment target (54% lower).

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT06664619 names 20 study sites across 4 states, led by California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT06664619 about?

NCT06664619 is a clinical study titled "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...

What is the current status of trial NCT06664619?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 724 participants. The study started on 2024-12-12. Estimated completion is 2026-05-31.

What conditions does trial NCT06664619 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT06664619?

The interventions under investigation include: Placebo (DRUG), Fp/ABS (DRUG), FP (DRUG), ABS (DRUG).

Who is sponsoring clinical trial NCT06664619?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06664619 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Asthma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06664619's enrollment target sits among peer trials

724 58th of 374 higher than 317 of 374 other Asthma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06664619, the US trial registry maintained by the National Library of Medicine. NCT06664619 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.