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

Asthma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06290102
• Other study ID #: TV56248-RES-10204
• Status: Recruiting
• Phase: Phase 1
• Start date: May 7, 2024
• Est. completion date: December 14, 2024

Study information

• Verified date: May 2024
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: Teva U.S. Medical Information
• Phone: 1-888-483-8279
• Email: USMedInfo[@]tevapharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 14, 2024
• Est. primary completion date: November 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• TEV-56248
Pharmaceutical form: Dry powder Route of administration: Oral inhalation
• Fp MDPI
Pharmaceutical form: Dry powder Route of administration: Oral inhalation

Locations

Country	Name	City	State
United States	Teva Investigational Site 12001	Boerne	Texas
United States	Teva Investigational Site 12003	Long Beach	California
United States	Teva Investigational Site 12002	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)		Up to 24 hours postdose
Primary	Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)		Up to 24 hours postdose
Primary	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
Primary	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
Primary	Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp		Up to 24 hours postdose
Primary	Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS		Up to 24 hours postdose
Primary	Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp		Up to 24 hours postdose
Primary	Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS		Up to 24 hours postdose
Primary	Last Measurable Concentration Above the Quantification Limit (Clast) of Fp		Up to 24 hours postdose
Primary	Last Measurable Concentration Above the Quantification Limit (Clast) of ABS		Up to 24 hours postdose
Primary	Time of Last Measurable Concentration (tlast) of Fp		Up to 24 hours postdose
Primary	Time of Last Measurable Concentration (tlast) of ABS		Up to 24 hours postdose
Secondary	Number of Participants with Adverse Events (AEs)		Up to 2 Months
Secondary	Number of Participants with Serious Adverse Events (SAEs)		Up to 2 Months
Secondary	Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs)		Up to 2 Months