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

NCT06290102 | Completed Phase 1 FDA Drug

• 1 other identifier: TV56248-RES-10204
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

Brief 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 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

Conditions

Asthma

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

Secondary Outcomes (3)

• 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

Study Arms (6)

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

Interventions

TEV-56248 DRUG

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)

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

Fp MDPI DRUG

Pharmaceutical form: Dry powder Route of administration: Oral inhalation

Also known as: - fluticasone propionate multidose dry powder inhaler

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (10)

Teva Investigational Site 12010

Mobile, Alabama, 36608, United States

Location

Teva Investigational Site 12003

Long Beach, California, 90815, United States

Location

Teva Investigational Site 12007

Miami, Florida, 33130, United States

Location

Teva Investigational Site 12005

Miami, Florida, 33142, United States

Location

Teva Investigational Site 12002

Miami, Florida, 33155, United States

Location

Teva Investigational Site 12008

Lafayette, Louisiana, 70508, United States

Location

Teva Investigational Site 12011

Columbia, Missouri, 65203, United States

Location

Teva Investigational Site 12012

Oklahoma City, Oklahoma, 73120-9389, United States

Location

Teva Investigational Site 12001

Boerne, Texas, 78006, United States

Location

Teva Investigational Site 12009

San Antonio, Texas, 78249, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: May 16, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 7, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (10)