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RECRUITING Phase 3

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

NCT06052267 · View on ClinicalTrials.gov ↗

Study Summary

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

Conditions Studied

Interventions

  • DRUG TEV-56248
  • DRUG Albuterol sulfate

Study Locations (20)

California

  • Teva Investigational Site 15685 — Bakersfield
  • Teva Investigational Site 15721 — Fresno
  • Teva Investigational Site 15788 — Huntington Beach
  • Teva Investigational Site 15720 — La Jolla
  • Teva Investigational Site 15687 — La Palma
  • Teva Investigational Site 15708 — Long Beach
  • Teva Investigational Site 15712 — Long Beach
  • Teva Investigational Site 15643 — Los Angeles
  • Teva Investigational Site 15695 — Napa
  • Teva Investigational Site 15692 — Northridge
  • Teva Investigational Site 15682 — Redondo Beach
  • Teva Investigational Site 15629 — San Bernardino
  • Teva Investigational Site 15709 — San Diego
  • Teva Investigational Site 15704 — San Jose

Alabama

  • Teva Investigational Site 15706 — Birmingham
  • Teva Investigational Site 15786 — Birmingham
  • Teva Investigational Site 15768 — Dothan

Arizona

  • Teva Investigational Site 15581 — Paradise Valley
  • Teva Investigational Site 15710 — Scottsdale
  • Teva Investigational Site 15661 — Tucson

Trial Details

FieldValue
Enrollment Target 2,700 participants
Start Date 2023-08-30
Est. Completion 2026-10-31
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06052267

The ClinicalTrials.gov registry entry for NCT06052267 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 103 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions — of which TEV-56248 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06052267 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06052267 about?

NCT06052267 is a clinical study titled "A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations". 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 e...

What is the current status of trial NCT06052267?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 2,700 participants. The study started on 2023-08-30. Estimated completion is 2026-10-31.

What conditions does trial NCT06052267 study?

This clinical trial studies the following conditions: Asthma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06052267?

The interventions under investigation include: TEV-56248 (DRUG), Albuterol sulfate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06052267?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 103 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06052267 being conducted?

This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial