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

August 11, 2025 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The planned duration for this trial is approximately 1.5 to 3 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence ABC
Drug: TEV-56248

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate/albuterol sulfate multidose dry powder inhaler with e-module (Fp/ABS eMDPI)
Drug: Fp MDPI

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate multidose dry powder inhaler
Experimental: Sequence ACB
Drug: TEV-56248

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate/albuterol sulfate multidose dry powder inhaler with e-module (Fp/ABS eMDPI)
Drug: Fp MDPI

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate multidose dry powder inhaler
Experimental: Sequence BAC
Drug: TEV-56248

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate/albuterol sulfate multidose dry powder inhaler with e-module (Fp/ABS eMDPI)
Drug: Fp MDPI

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate multidose dry powder inhaler
Experimental: Sequence BCA
Drug: TEV-56248

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate/albuterol sulfate multidose dry powder inhaler with e-module (Fp/ABS eMDPI)
Drug: Fp MDPI

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate multidose dry powder inhaler
Experimental: Sequence CAB
Drug: TEV-56248

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate/albuterol sulfate multidose dry powder inhaler with e-module (Fp/ABS eMDPI)
Drug: Fp MDPI

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate multidose dry powder inhaler
Experimental: Sequence CBA
Drug: TEV-56248

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate/albuterol sulfate multidose dry powder inhaler with e-module (Fp/ABS eMDPI)
Drug: Fp MDPI

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other Names:
  • - fluticasone propionate multidose dry powder inhaler

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)
Time Frame: Up to 24 hours postdose
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
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
Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of Fp
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of ABS
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of Fp
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of ABS
Time Frame: Up to 24 hours postdose
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
Up to 24 hours postdose
AUC0-24 of Albuterol Sulfate
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 2 Months
Up to 2 Months
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to 2 Months
Up to 2 Months
Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 2 Months
Up to 2 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TV56248-RES-10204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on TEV-56248

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings