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

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: TEV-56248; Drug: Fp MDPI

Study type: Interventional

Funder types: Industry

Identifiers

NCT06290102

TV56248-RES-10204

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 6 patient groups

Sequence 1

Experimental group

Treatment:

Drug: Fp MDPI

Drug: TEV-56248

Sequence 2

Experimental group

Treatment:

Drug: Fp MDPI

Drug: TEV-56248

Sequence 3

Experimental group

Treatment:

Drug: Fp MDPI

Drug: TEV-56248

Sequence 4

Experimental group

Treatment:

Drug: Fp MDPI

Drug: TEV-56248

Sequence 5

Experimental group

Treatment:

Drug: Fp MDPI

Drug: TEV-56248

Sequence 6

Experimental group

Treatment:

Drug: Fp MDPI

Drug: TEV-56248