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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517991-39-00
Acronym
FpA-AS-30093
Enrollment
555
Registered
2025-06-04
Start date
2025-07-22
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

Baseline-adjusted post-dose forced expiratory volume in one second (FEV1) area under the effect curve from time zero to 6 hours (AUEC0-6hr) over 4 weeks (FEV1 AUEC0-6hr), Baseline-adjusted trough FEV1at week 4

Detailed description

Time to 15% improvement from baseline FEV1 post-dose on day 1., Time to 12% improvement from baseline FEV1 post-dose on day 1., Duration of 15% increase in FEV1 from baseline post-dose on day 1, Asthma Control Questionnaire-6 (ACQ-6) response at week 4 defined as achieving a decrease in score from baseline value of at least 0.5 for participants with a baseline ACQ-6 score of ≥1.5, Asthma Control Test (ACT) score response at week 4 defined as achieving an increase in score from baseline value of at least 3, Occurrence of adverse events during the trial., Occurrence of serious adverse events during the trial., Treatment withdrawal due to treatment-emergent adverse events., Plasma concentration of Fp and ABS at the specified timepoints

Interventions

DRUGFluticasone propionate
DRUGArmonAir® Digihaler®
DRUGPlacebo TEV-56248
DRUGAlbuterol Sulfate HFA

Sponsors

Teva Branded Pharmaceutical Products R&D LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Baseline-adjusted post-dose forced expiratory volume in one second (FEV1) area under the effect curve from time zero to 6 hours (AUEC0-6hr) over 4 weeks (FEV1 AUEC0-6hr), Baseline-adjusted trough FEV1at week 4

Secondary

MeasureTime frame
Time to 15% improvement from baseline FEV1 post-dose on day 1., Time to 12% improvement from baseline FEV1 post-dose on day 1., Duration of 15% increase in FEV1 from baseline post-dose on day 1, Asthma Control Questionnaire-6 (ACQ-6) response at week 4 defined as achieving a decrease in score from baseline value of at least 0.5 for participants with a baseline ACQ-6 score of ≥1.5, Asthma Control Test (ACT) score response at week 4 defined as achieving an increase in score from baseline value of at least 3, Occurrence of adverse events during the trial., Occurrence of serious adverse events during the trial., Treatment withdrawal due to treatment-emergent adverse events., Plasma concentration of Fp and ABS at the specified timepoints

Countries

Bulgaria, Czechia, Germany, Poland, Romania, Slovakia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026