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

Phase 3

Recruiting

• Conditions: Asthma
• Interventions: Drug: TEV-56248; Drug: Albuterol sulfate

• Registration Number: NCT06052267
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

The primary objective of the study is to assess 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-30
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-04
• Primary Completion: 2026-07-17
• Study Completion: 2026-07-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2196

Inclusion Criteria

• The participant has a documented 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) ending within the past 12 month.
• 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 smoker and/or has a history of ≥10 pack years history of smoking. A current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months.
• The participant has significantly abused alcohol and/or illicit 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEV-56248 Low Dose	TEV-56248	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.
TEV-56248 High Dose	TEV-56248	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.
Albuterol sulfate	Albuterol sulfate	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.

Primary Outcome Measures

Name	Time	Method
Time to First Severe Clinical Asthma Exacerbation (CAE)	Up to 35 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants with at Least One Serious Adverse Event	Up to 35 months
Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events	Up to 35 months
Annualized Severe CAE Rate	Up to 35 months	Annualized severe CAE rate is calculated for each participant as the sum of total number of CAE events divided by the duration of follow up time (years).
Asthma Control Questionnaire-5 (ACQ-5) Response	Baseline, Week 24	Response is defined as achieving a decrease in score from baseline value of at least 0.5 (participants aged ≥6 years).; The ACQ-5 is a shortened version of the validated asthma assessment tool (ie, ACQ) and includes 5 questions that are self-assessments (completed by the participant). Each item on the ACQ-5 has a possible score ranging from 0 to 6, and the total score is the mean of all responses.
Total Annualized SCS Exposure Over the Treatment Period	Up to 35 months	Total annualized SCS exposure will be calculated for each participant as the sum of the cumulative doses of SCS divided by the duration of time (years) the participant was in the treatment period, from randomization and up to end of treatment.
Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)	Baseline, Week 24	Responders are defined as the composite of participants achieving an increase in score from baseline of at least 0.5 on the AQLQ+12 or PAQLQ (participants aged ≥7 years).; The AQLQ + 12 is a modified version of the standardized AQLQ, which was developed to measure functional impairments experienced by adults ≥17 years of age. The AQLQ + 12 is valid for participants aged 12 to 70 years and includes 32 questions in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). Responses are rated on a 7-point scale where 7 = no impairment and 1 = severe impairment.; The PAQLQ Questionnaire includes 23 items in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered). It is intended for participants ages 7-11.
Number of Participants with at Least One Adverse Event	Up to 35 months	Adverse events include clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), and 12-lead electrocardiogram (ECG) findings.

Trial Locations

Locations (375)

Teva Investigational Site 15768; 🇺🇸 Dothan, Alabama, United States

Teva Investigational Site 15581; 🇺🇸 Paradise Valley, Arizona, United States

Teva Investigational Site 15661; 🇺🇸 Tucson, Arizona, United States

Teva Investigational Site 15685; 🇺🇸 Bakersfield, California, United States

Teva Investigational Site 15721; 🇺🇸 Fresno, California, United States

Teva Investigational Site 15788; 🇺🇸 Huntington Beach, California, United States

Teva Investigational Site 15720; 🇺🇸 La Jolla, California, United States

Teva Investigational Site 15687; 🇺🇸 La Palma, California, United States

Teva Investigational Site 15708; 🇺🇸 Long Beach, California, United States

Teva Investigational Site 15712; 🇺🇸 Long Beach, California, United States

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