AsthmaPhase 1NCT06290102

Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old

A Phase 1 study testing TEV-56248 and Fp MDPI in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objectives of this study are: To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module [Fp/ABS eMDPI]) in participants with asthma To compare the… Read more about this study

Who is it for?: Ages 4 to 11 years
Conditions the study is for: Asthma
What is being tested?: TEV-56248 and Fp MDPI
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 10 sitesUnited States
Study dates: 16 May 2024to 7 Oct 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Participant has a diagnosis of asthma as defined by the Global Initiative for Asthma guidelines (GINA 2023), which has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days before the Screening Visit
Has persistent asthma, with a forced expiratory value (FEV1) that is greater than or equal to 80% of the value predicted for age, height, sex, and race at the Screening Visit
Demonstrate acceptable inhalation technique with the training inhaler
Able to stop (as judged by the Investigator) his or her rescue medication, for approximately 6 hours before the Screening Visit and for approximately 4 hours before training sessions in periods 1-3
Has body mass index (BMI) within the 3rd and 97th percentiles for the participant's age and gender. The participant must have a weight of ≥18 kilograms (kg)
Able to achieve a peak inspiratory flow (PIF) rate of at least 60 liters per minute (L/min) on an inhaler training device
NOTE- Additional criteria apply, please contact the investigator for more information

Who cannot join

Participant has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures
Has participated as a randomized participant in any investigational drug trial within 30 days (starting from the final follow-up visit of that trial) preceding the Screening Visit or plans to participate in another investigational drug trial at any time during this trial
Known hypersensitivity to any corticosteroid, albuterol, or any of the ingredients in the investigational medicinal product
Asthma exacerbation requiring systemic corticosteroids within 30 days of the Screening Visit, or has had any hospitalization for asthma within 2 months of the Screening Visit
NOTE- Additional criteria apply, please contact the investigator for more information

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Teva Investigational Site 12001
Boerne, Texas, 78006
Teva Investigational Site 12011
Columbia, Missouri, 65203
Teva Investigational Site 12008
Lafayette, Louisiana, 70508
Teva Investigational Site 12003
Long Beach, California, 90815
Teva Investigational Site 12007
Miami, Florida, 33130
Teva Investigational Site 12005
Miami, Florida, 33142
Teva Investigational Site 12002
Miami, Florida, 33155
Teva Investigational Site 12010
Mobile, Alabama, 36608
Teva Investigational Site 12012
Oklahoma City, Oklahoma, 73120-9389
Teva Investigational Site 12009
San Antonio, Texas, 78249

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About this study

Official title: An Open Label, Single Dose, 3-Period, Crossover Study to Determine the Pharmacokinetic Profile and Safety of Fluticasone Propionate/Albuterol Sulfate (Fp/ABS) Multidose Dry Powder Inhaler With e-Module (eMDPI) Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Participants With Asthma (4 to 11 Years Old)

The primary objectives of this study are:

To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module [Fp/ABS eMDPI]) in participants with asthma
To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI)
To compare the PK profiles of ABS between the 2 different strengths of TEV-56248

The secondary objective is:

To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI

Read the detailed description

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.

Conditions: Asthma
Being tested: TEV-56248, Fp MDPI
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TEV-56248Drug
Also called - fluticasone propionate/albuterol sulfate multidose dry powder inhaler with e-module (Fp/ABS eMDPI)
Pharmaceutical form: Dry powder
Route of administration: Oral inhalation
Fp MDPIDrug
Also called - fluticasone propionate multidose dry powder inhaler
Pharmaceutical form: Dry powder
Route of administration: Oral inhalation

Study groups in NCT06290102
Study group	Role	What they receive
Sequence ABC	Experimental	Not described Receives: Drug: TEV-56248; Drug: Fp MDPI
Sequence BCA	Experimental	Not described Receives: Drug: TEV-56248; Drug: Fp MDPI
Sequence CAB	Experimental	Not described Receives: Drug: TEV-56248; Drug: Fp MDPI
Sequence ACB	Experimental	Not described Receives: Drug: TEV-56248; Drug: Fp MDPI
Sequence BAC	Experimental	Not described Receives: Drug: TEV-56248; Drug: Fp MDPI
Sequence CBA	Experimental	Not described Receives: Drug: TEV-56248; Drug: Fp MDPI

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)
Measured: Up to 24 hours postdose
Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 24 hours postdose
AUC0-24 of Albuterol Sulfate
Measured: Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp
Measured: Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS
Measured: Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp
Measured: Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS
Measured: Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of Fp
Measured: Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of ABS
Measured: Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of Fp
Measured: Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of ABS
Measured: Up to 24 hours postdose

Secondary outcomes (3)

Number of Participants with Adverse Events (AEs)
Measured: Up to 2 Months
Number of Participants with Serious Adverse Events (SAEs)
Measured: Up to 2 Months
Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 2 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 20247 Oct 2024

First posted4 Mar 2024
Study start16 May 2024
Primary completion1 Oct 2024
Study completion7 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06290102
Sponsor's protocol ID: TV56248-RES-10204
Status last verified: Jul 2026
First submitted: 26 Feb 2024
Last updated: 4 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Single Dose, 3-Period, Crossover Study to Determine the Pharmacokinetic Profile and Safety of Fluticasone Propionate/Albuterol Sulfate (Fp/ABS) Multidose Dry Powder Inhaler With e-Module (eMDPI) Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Participants With Asthma (4 to 11 Years Old)
ClinicalTrials.gov ID: NCT06290102
Acronym / sponsor ID: TV56248-RES-10204
Conditions: Asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: 16 May 2024 (actual)
Primary completion: 1 Oct 2024 (actual)
Study completion: 7 Oct 2024 (actual)
First posted: 4 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objectives of this study are:

To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module [Fp/ABS eMDPI]) in participants with asthma
To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI)
To compare the PK profiles of ABS between the 2 different strengths of TEV-56248

The secondary objective is:

To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence ABC	Experimental	Drug: TEV-56248, Drug: Fp MDPI
Sequence BCA	Experimental	Drug: TEV-56248, Drug: Fp MDPI
Sequence CAB	Experimental	Drug: TEV-56248, Drug: Fp MDPI
Sequence ACB	Experimental	Drug: TEV-56248, Drug: Fp MDPI
Sequence BAC	Experimental	Drug: TEV-56248, Drug: Fp MDPI
Sequence CBA	Experimental	Drug: TEV-56248, Drug: Fp MDPI

Who may qualify

Ages: 4 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Participant has a diagnosis of asthma as defined by the Global Initiative for Asthma guidelines (GINA 2023), which has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days before the Screening Visit
Has persistent asthma, with a forced expiratory value (FEV1) that is greater than or equal to 80% of the value predicted for age, height, sex, and race at the Screening Visit
Demonstrate acceptable inhalation technique with the training inhaler
Able to stop (as judged by the Investigator) his or her rescue medication, for approximately 6 hours before the Screening Visit and for approximately 4 hours before training sessions in periods 1-3
Has body mass index (BMI) within the 3rd and 97th percentiles for the participant's age and gender. The participant must have a weight of ≥18 kilograms (kg)

Key exclusion criteria (5 listed)

Participant has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures
Has participated as a randomized participant in any investigational drug trial within 30 days (starting from the final follow-up visit of that trial) preceding the Screening Visit or plans to participate in another investigational drug trial at any time during this trial
Known hypersensitivity to any corticosteroid, albuterol, or any of the ingredients in the investigational medicinal product
Asthma exacerbation requiring systemic corticosteroids within 30 days of the Screening Visit, or has had any hospitalization for asthma within 2 months of the Screening Visit
NOTE- Additional criteria apply, please contact the investigator for more information

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TEV-56248Also: - fluticasone propionate/albuterol sulfate multidose dry powder inhaler with e-module (Fp/ABS eMDPI)Pharmaceutical form: Dry powder Route of administration: Oral inhalation	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
Fp MDPIAlso: - fluticasone propionate multidose dry powder inhalerPharmaceutical form: Dry powder Route of administration: Oral inhalation	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA

Primary outcome

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

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Teva Medical Expert, MD study director

Teva Branded Pharmaceutical Products R&D, Inc.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TEV-56248 and Fp MDPI in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp) (time frame: Up to 24 hours postdose). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06290102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.