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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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 44 days later Sep 19, 2026 → Nov 2, 2026
See other at-risk trials from Teva Branded Pharmaceutical Products R&D LLC

Record History

The 50 most recent of 53 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Teva Branded Pharmaceutical Products R&D LLC to Teva Branded Pharmaceutical Products R&D LLC Enrollment closed, study ongoing · Primary and study completion pushed from Sep 19, 2026 to Nov 2, 2026 · Final enrollment: 649 participants (planned 724) · 2 more Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Primary and study completion pushed from Sep 19, 2026 to Nov 2, 2026
    • Final enrollment: 649 participants (planned 724)
    • Interventions: ABS (Drug), FP (Drug), Fp/ABS (Drug), Placebo (Drug) to ABS (Drug), FP (Drug), Fp/ABS (Drug), Placebo (Drug)
    • Site details revised at 189 of 189 sites
  2. Trial sites expanded: 183 → 189 locationsv52
  3. Trial sites expanded: 178 → 183 locationsv51
  4. Trial sites expanded: 175 → 178 locationsv50
  5. Re-verified, no change to tracked fieldsv49
  6. Primary and study completion pushed from May 31, 2026 to Sep 19, 2026 Study sites revised (175)v48 Show 1 more changeShow less
    • Study sites revised (175)

    See this version in full on ClinicalTrials.gov ↗

  7. Trial sites expanded: 163 → 175 locationsv47
  8. Trial sites expanded: 156 → 163 locationsv46
  9. Trial sites expanded: 149 → 156 locationsv45
  10. Sponsor changed: Teva Branded Pharmaceutical Products R&D, Inc. to Teva Branded Pharmaceutical Products R&D LLC Trial sites expanded: 140 → 149 locationsv44 Show 1 more changeShow less
    • Trial sites expanded: 140 → 149 locations

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 138 to 140v43
  12. Study sites: 137 to 138v42
  13. Study sites: 134 to 137v41
  14. Site details revised at 1 of 134 sitesv40
  15. Study sites: 133 to 134v39
  16. Study sites: 132 to 133v38
  17. Study sites: 129 to 132v37
  18. Study sites: 128 to 129v36
  19. Study sites: 124 to 128v35
  20. Study sites: 119 to 124v34
  21. Study sites: 114 to 119v33
  22. Study sites: 113 to 114v32
  23. Study sites: 112 to 113v31
  24. Study sites: 110 to 112v30
  25. Study sites: 106 to 110v29
  26. Study sites: 104 to 106v28
  27. Study sites: 95 to 104v27
  28. Study sites: 88 to 95v26
  29. Study sites: 84 to 88v25
  30. Study sites: 72 to 84v24
  31. Study sites: 60 to 72v23
  32. Study sites: 56 to 60v22
  33. Study sites: 54 to 56v21
  34. Study sites: 50 to 54v20
  35. Study sites: 49 to 50v19
  36. Study sites: 45 to 49v18
  37. Study sites: 43 to 45v17
  38. Study sites: 39 to 43v16
  39. Study sites: 34 to 39v15
  40. Study sites: 30 to 34v14
  41. Study sites: 28 to 30v13
  42. Study sites: 24 to 28v12
  43. Study sites: 21 to 24v11
  44. Study sites: 20 to 21v10
  45. Study sites: 19 to 20v9
  46. Study sites: 18 to 19v8
  47. Study sites: 16 to 18v7
  48. Study sites: 12 to 16v6
  49. Study sites: 10 to 12v5
  50. Study sites: 8 to 10v4
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06664619
Lead Sponsor Teva Branded Pharmaceutical Products R&D LLC
Conditions Asthma
Enrollment 649 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov