Asthma
Conditions
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.
Interventions
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of Last Measurable Concentration (tlast) 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of Participants with Adverse Events (AEs) | Up to 2 Months |
Countries
United States
Outcome results
None listed