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A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 86 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Site details revised at 1 of 393 sites
  4. Lead sponsor: Teva Branded Pharmaceutical Products R&D LLC to Teva Branded Pharmaceutical Products R&D LLC Primary endpoints: details revised at 1 of 1 entry · Secondary endpoints: details revised at 3 of 8 entries Show 2 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Secondary endpoints: details revised at 3 of 8 entries
  5. Site details revised at 1 of 393 sitesv82
Show 9 earlier versionsHide 9 earlier versions
  1. 5 versions Re-verified since Jun 18, 2026, no change to tracked fieldsv77-v81
  2. Site details revised at 12 of 393 sitesv76
  3. 3 versions Re-verified since May 21, 2026, no change to tracked fieldsv73-v75
  1. Trial status changed: Recruiting → Active, Not Recruiting Enrollment target: estimated 2700 to confirmed 2772 · Site details revised at 393 of 393 sitesv72 Show 2 more changesShow less
    • Enrollment target: estimated 2700 to confirmed 2772
    • Site details revised at 393 of 393 sites
  2. Site details revised at 268 of 393 sitesv71
  3. Site details revised at 1 of 393 sitesv70
  4. Site details revised at 3 of 393 sitesv69
  5. Site details revised at 2 of 393 sitesv68
  6. Site details revised at 20 of 393 sitesv67
  7. Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc. to Teva Branded Pharmaceutical Products R&D LLC Enrollment target: 2196 to 2700 · Primary and study completion dates: Jul 17, 2026 to Oct 31, 2026 · Site details revised at 2 of 393 sitesv66 Show 3 more changesShow less
    • Enrollment target: 2196 to 2700
    • Primary and study completion dates: Jul 17, 2026 to Oct 31, 2026
    • Site details revised at 2 of 393 sites
  8. Study sites: 392 to 393v65
  9. Site details revised at 69 of 392 sitesv64
  10. Study sites: 393 to 392v63
  11. Study sites: 392 to 393v62
  12. Study sites: 389 to 392v61
  13. Study sites: 387 to 389v60
  14. Site details revised at 2 of 387 sitesv59
  15. Study sites: 384 to 387v58
  16. Study sites: 381 to 384v57
  17. Study sites: 380 to 381v56
  18. Study sites: 379 to 380v55
  19. Study sites: 378 to 379v54
  20. Study sites: 375 to 378v53
  21. Study sites: 372 to 375v52
  22. Site details revised at 5 of 372 sitesv51
  23. Study sites: 370 to 372v50
  24. Site details revised at 4 of 370 sitesv49
  25. Study sites: 364 to 370v48
  26. Study sites: 363 to 364v47
  27. Study sites: 362 to 363v46
  28. Study sites: 360 to 362v45
  29. Trial status: Active, Not Recruiting to Recruiting Study sites: 353 to 360v44 Show 1 more changeShow less
    • Study sites: 353 to 360
  30. Study sites: 347 to 353v43
  31. Trial status: Recruiting to Active, Not Recruiting Study sites: 344 to 347v42 Show 1 more changeShow less
    • Study sites: 344 to 347
  32. Study sites: 342 to 344v41
  33. Study sites: 338 to 342v40
  34. Study sites: 335 to 338v39
  35. Study sites: 332 to 335v38
  36. Study sites: 326 to 332v37
  • 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 study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs). Secondary Objectives: To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure To evaluate the safety and tolerability of Fp/A BS The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria
Trial Details
NCT Number NCT06052267
Lead Sponsor Teva Branded Pharmaceutical Products R&D LLC
Conditions Asthma
Enrollment 2,772 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov