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NCT Number: NCT06290102

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

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

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Key information

Conditions

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

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Teva Investigational Site 12010, Mobile, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEV-56248

Drug

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)

Fp MDPI

Drug

Pharmaceutical form: Dry powder

Route of administration: Oral inhalation

Other names: - fluticasone propionate multidose dry powder inhaler

Primary outcomes

  1. Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)

    Time frame: Up to 24 hours postdose

  2. Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)

    Time frame: Up to 24 hours postdose

  3. 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

  4. 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

  5. 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

  6. AUC0-24 of Albuterol Sulfate

    Time frame: Up to 24 hours postdose

  7. Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp

    Time frame: Up to 24 hours postdose

  8. Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS

    Time frame: Up to 24 hours postdose

  9. Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp

    Time frame: Up to 24 hours postdose

  10. Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS

    Time frame: Up to 24 hours postdose

  11. Last Measurable Concentration Above the Quantification Limit (Clast) of Fp

    Time frame: Up to 24 hours postdose

  12. Last Measurable Concentration Above the Quantification Limit (Clast) of ABS

    Time frame: Up to 24 hours postdose

  13. Time of Last Measurable Concentration (tlast) of Fp

    Time frame: Up to 24 hours postdose

  14. Time of Last Measurable Concentration (tlast) of ABS

    Time frame: Up to 24 hours postdose

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 2 Months

  2. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to 2 Months

  3. Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 2 Months

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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