A Phase 1 interventional study of TEV-56248 and Fp MDPI in Asthma, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 10 sites in United States. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 1, Interventional, and Treatment
The primary objectives of this study are:
The secondary objective is:
The planned treatment duration for this trial is approximately 1.5 to 2 months. The trial includes a 14-day screening period, 3 treatment periods (2 days each), and a follow up visit 7 days after end of treatment.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 30 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 206 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) 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.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: TEV-56248 · Drug: Fp MDPI
Drug: TEV-56248 · Drug: Fp MDPI
Drug: TEV-56248 · Drug: Fp MDPI
Drug: TEV-56248 · Drug: Fp MDPI
Drug: TEV-56248 · Drug: Fp MDPI
Drug: TEV-56248 · Drug: Fp MDPI
Pharmaceutical form: Dry powder Route of administration: Oral inhalation
Also known as: - fluticasone propionate/albuterol sulfate multidose dry powder inhaler with e-module (Fp/ABS eMDPI)
Pharmaceutical form: Dry powder Route of administration: Oral inhalation
Also known as: - fluticasone propionate multidose dry powder inhaler
Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)
Time frame: Up to 24 hours postdose
Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)
Time frame: Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp
Time frame: Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS
Time frame: Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Fluticasone Propionate
Time frame: Up to 24 hours postdose
AUC0-24 of Albuterol Sulfate
Time frame: Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp
Time frame: Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS
Time frame: Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp
Time frame: Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS
Time frame: Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of Fp
Time frame: Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of ABS
Time frame: Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of Fp
Time frame: Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of ABS
Time frame: Up to 24 hours postdose
Number of Participants with Adverse Events (AEs)
Time frame: Up to 2 Months
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 2 Months
Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 2 Months
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.
Ran from May 2024 to primary completion in Oct 2024, 4 months.
Of 173 industry-sponsored phase 1 interventional studies under Asthma, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 4 months is below that.
Counting every sponsor, half of 200 studies reached it within 6 months; a quarter within 3 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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