A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

Teva Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Asthma

Treatments: Drug: Albuterol sulfate; Drug: TEV-56248

Study type: Interventional

Funder types: Industry

Identifiers

NCT06052267

FpA-AS-30094

2023-505435-12-00 (Other Identifier)

Details and patient eligibility

About

The primary objective of the study is to demonstrate the efficacy of high dose and low dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs).

Secondary Objectives:

To evaluate the efficacy of Fp/ABS compared to ABS and the effect on systemic corticosteroid (SCS) exposure To evaluate the safety and tolerability of Fp/A BS

The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 35 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria.

Enrollment: 2,196 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The participant has a diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines.
• The participant has a documented history of at least 1 severe clinical asthma exacerbation (CAE) within the past 12 months before screening.
• The participant is using any prescribed inhaled asthma controller medication (at a stable dose for 1 month prior to the screening visit).
• If female, the participant is currently not pregnant, breastfeeding, or attempting to become pregnant (for at least 30 days before the screening visit and throughout the duration of the study), or is of nonchildbearing potential

NOTE- Additional criteria apply, please contact the investigator for more information.

Exclusion criteria

• The participant has life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years before screening.
• The participant has a suspected bacterial or viral infection (other than Coronavirus Disease [COVID-19]) of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period.
• Participants with a confirmed infection with COVID-19 within 6 weeks prior to the screening visit, or with residual COVID-19 symptoms ("long COVID-19").
• The participant has had a clinical asthma exacerbation (CAE) requiring systemic corticosteroids within 30 days before screening, or any hospitalization for asthma within 2 months before screening.
• The participant is a current tobacco smoker or has a smoking history of ≥10 pack-years, or the participant used tobacco within the past 6 months.
• The participant has significantly abused alcohol and/or prohibited drugs within the previous 24 months.
• The participant has participated as a randomized participant in any investigational drug study within 30 days.
• The participant has been hospitalized for psychiatric disorder or attempted suicide within 1 year of screening.

NOTE- Additional criteria apply, please contact the investigator for more information

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,196 participants in 3 patient groups

TEV-56248 Low Dose

Experimental group

Description:

Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.

Treatment:

Drug: TEV-56248

TEV-56248 High Dose

Experimental group

Description:

Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.

Treatment:

Drug: TEV-56248

Albuterol sulfate

Active Comparator group

Description:

Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.

Treatment:

Drug: Albuterol sulfate