Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06052267 · ClinicalTrials.gov registry record · Phase 3
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
A Phase 3 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 2,700
- Enrollment target
- 20
- Study locations
NCT06052267 is a Phase 3 study of Asthma that is actively recruiting participants, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 2,700 participants, above the 1,556-participant average among 374 other Asthma trials with a reported enrollment target (74% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT06052267, a Phase 3 study of Asthma, is actively recruiting participants, sponsored by Teva Branded Pharmaceutical Products R&D.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,700 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 2,700 participants |
| Start Date | 2023-08-30 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 2,700 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,556-participant average among 374 other Asthma trials with a reported enrollment target (74% higher). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
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.
NCT06052267 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Alabama, Arizona.
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.
What interventions are being tested in trial NCT06052267?
The interventions under investigation include: TEV-56248 (DRUG), Albuterol sulfate (DRUG).
Who is sponsoring clinical trial NCT06052267?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
RECRUITING · Phase 3
-
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
RECRUITING · Phase 3
-
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
RECRUITING · Phase 3
-
A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
RECRUITING · Phase 3
-
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
RECRUITING · Phase 3
-
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.