Clinical trial 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)
timeFrame: Up to 24 hours postdose
measure: Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)
timeFrame: Up to 24 hours postdose
measure: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp
timeFrame: Up to 24 hours postdose
measure: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS
timeFrame: Up to 24 hours postdose
measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp
timeFrame: Up to 24 hours postdose
measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS
timeFrame: Up to 24 hours postdose
measure: Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp
timeFrame: Up to 24 hours postdose
measure: Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS
timeFrame: Up to 24 hours postdose
measure: Last Measurable Concentration Above the Quantification Limit (Clast) of Fp
timeFrame: Up to 24 hours postdose
measure: Last Measurable Concentration Above the Quantification Limit (Clast) of ABS
timeFrame: Up to 24 hours postdose
measure: Time of Last Measurable Concentration (tlast) of Fp
timeFrame: Up to 24 hours postdose
measure: Time of Last Measurable Concentration (tlast) of ABS
timeFrame: Up to 24 hours postdose
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 2 Months
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 2 Months
measure: Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 2 Months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Teva Investigational Site 12010
state: Alabama
city: Long Beach
country: United States
facility: Teva Investigational Site 12003
state: California
city: Miami
country: United States
facility: Teva Investigational Site 12007
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12005
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12002
state: Florida
city: Lafayette
country: United States
facility: Teva Investigational Site 12008
state: Louisiana
city: Columbia
country: United States
facility: Teva Investigational Site 12011
state: Missouri
city: Oklahoma City
country: United States
facility: Teva Investigational Site 12012
state: Oklahoma
city: Boerne
country: United States
facility: Teva Investigational Site 12001
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 12009
state: Texas
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: