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 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Fluticasone Propionate/Albuterol Sulfate Combination Compared to Fluticasone Propionate, Albuterol Sulfate or Placebo Delivered by Multidose Dry Powder Inhaler in Participants 12 Years and Older With Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Listed as NCT06664619, this observational or N/A phase trial focuses on Asthma and remains actively recruiting participants. Sponsored by Teva Branded Pharmaceutical Products R&D LLC, it has been updated 17 times since 2024, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
17 versions recorded-
Apr 21, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
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Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE3
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE3
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE3
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE3
▶ Show 12 earlier versions
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE3
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE3
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE3
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE3
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Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE3
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Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE3
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May 2025 — Jun 2025 [monthly]
Recruiting PHASE3
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Apr 2025 — May 2025 [monthly]
Recruiting PHASE3
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Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE3
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Feb 2025 — Mar 2025 [monthly]
Recruiting PHASE3
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Jan 2025 — Feb 2025 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Nov 2024 — Jan 2025 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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.
Contact Information
- Teva Branded Pharmaceutical Products R&D LLC
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Adana, Turkey (Türkiye) , Ahrensburg, Germany , Austin, United States , Austin, United States , Belgrade, Serbia , Belgrade, Serbia , Belgrade, Serbia , Belgrade, Serbia , Bendorf, Germany , Berlin, Germany and 139 more locations