A Phase 3 interventional study of TEV-56248 and Albuterol sulfate in Asthma, sponsored by Teva Branded Pharmaceutical Products R&D LLC. Active, not recruiting at 391 sites in 22 countries. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Teva Branded Pharmaceutical Products R&D LLC (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment
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
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 2,769 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Teva Branded Pharmaceutical Products R&D LLC is the lead sponsor of 24 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
NOTE- Additional criteria apply, please contact the investigator for more information.
Exclusion Criteria:
NOTE- Additional criteria apply, please contact the investigator for more information
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Drug: TEV-56248
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Drug: TEV-56248
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Drug: Albuterol sulfate
Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Oral inhalation powder
Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI
Time frame: Up to 42 months
Time to first severe CAE with Low Dose (LD) Fp/ABS eMDPI
Time frame: Up to 42 months
Annualized Severe CAE Rate
Annualized severe CAE rate is calculated for each participant as the sum of total number of CAE events divided by the duration of follow up time (years).
Time frame: Up to 42 months
Total Annualized SCS Exposure Over the Treatment Period
Total annualized SCS exposure will be calculated for each participant as the sum of the cumulative doses of SCS divided by the duration of time (years) the participant was in the treatment period, from randomization and up to end of treatment.
Time frame: Up to 42 months
Asthma Control Questionnaire-5 (ACQ-5) Response
Response is defined as achieving a decrease in score from baseline value of at least 0.5 (participants aged ≥6 years). The ACQ-5 is a shortened version of the validated asthma assessment tool (ie, ACQ) and includes 5 questions that are self-assessments (completed by the participant). Each item on the ACQ-5 has a possible score ranging from 0 to 6, and the total score is the mean of all responses.
Time frame: Baseline, Week 24
Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)
Responders are defined as the composite of participants achieving an increase in score from baseline of at least 0.5 on the AQLQ+12 or PAQLQ (participants aged ≥7 years). The AQLQ + 12 is a modified version of the standardized AQLQ, which was developed to measure functional impairments experienced by adults ≥17 years of age. The AQLQ + 12 is valid for participants aged 12 to 70 years and includes 32 questions in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). Responses are rated on a 7-point scale where 7 = no impairment and 1 = severe impairment. The PAQLQ Questionnaire includes 23 items in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered). It is intended for participants ages 7-11.
Time frame: Baseline, Week 24
Number of Participants with at Least One Adverse Event
Adverse events include clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), and 12-lead electrocardiogram (ECG) findings.
Time frame: Up to 42 months
Number of Participants with at Least One Serious Adverse Event
Time frame: Up to 42 months
Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events
Time frame: Up to 42 months
Showing the first 100 of 391 sites across 22 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for Dec 2026, 40 months after the start.
Of 173 industry-sponsored phase 3 interventional studies under Asthma, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's planned 40 months is above that.
Counting every sponsor, half of 205 studies reached it within 27 months; a quarter within 14 and three quarters within 42.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Oct 2026 → Dec 2026 and completion Oct 2026 → Dec 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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