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

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: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: TEV-56248; Drug: Fp MDPI

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: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events (AEs)	Up to 2 Months
Number of Participants with Serious Adverse Events (SAEs)	Up to 2 Months
Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs)	Up to 2 Months

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 7, 2024

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Autonomic Agents; Peripheral Nervous System Agents; Reproductive Control Agents; Dermatologic Agents; Neurotransmitter Agents; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Fluticasone; Xhance; Albuterol
• Other Study ID 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