A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations (NCT06052267)
A Randomized, Double-Blind, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Fixed-Dose Combination on Severe Asthma Exacerbations in Patients With Asthma
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Teva Investigational Site 15706 — Birmingham, Alabama
Age range: 4 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (393 Sites)
Showing the first 25 of 393 sites.
- Teva Investigational Site 15706 — Birmingham, Alabama
- Teva Investigational Site 15786 — Birmingham, Alabama
- Teva Investigational Site 15768 — Dothan, Alabama
- Teva Investigational Site 15581 — Paradise Valley, Arizona
- Teva Investigational Site 15710 — Scottsdale, Arizona
- Teva Investigational Site 15661 — Tucson, Arizona
- Teva Investigational Site 15685 — Bakersfield, California
- Teva Investigational Site 15721 — Fresno, California
- Teva Investigational Site 15788 — Huntington Beach, California
- Teva Investigational Site 15720 — La Jolla, California
- Teva Investigational Site 15687 — La Palma, California
- Teva Investigational Site 15708 — Long Beach, California
- Teva Investigational Site 15712 — Long Beach, California
- Teva Investigational Site 15643 — Los Angeles, California
- Teva Investigational Site 15695 — Napa, California
- Teva Investigational Site 15692 — Northridge, California
- Teva Investigational Site 15682 — Redondo Beach, California
- Teva Investigational Site 15629 — San Bernardino, California
- Teva Investigational Site 15709 — San Diego, California
- Teva Investigational Site 15704 — San Jose, California
- Teva Investigational Site 15620 — Stockton, California
- Teva Investigational Site 15621 — Westminster, California
- Teva Investigational Site 15612 — Aurora, Colorado
- Teva Investigational Site 15588 — Colorado Springs, Colorado
- Teva Investigational Site 15765 — Colorado Springs, Colorado
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.