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NCT Number: NCT06052267

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

The primary objective of the study is to assess the efficacy of high 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 low dose 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 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Teva Investigational Site 20109, Bahía Blanca, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEV-56248

Drug

Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.

Albuterol sulfate

Drug

Oral inhalation powder

Primary outcomes

  1. Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI

    Time frame: Up to 42 months

Secondary outcomes

  1. Time to first severe CAE with Low Dose (LD) Fp/ABS eMDPI

    Time frame: Up to 42 months

  2. Annualized Severe CAE Rate

    Time frame: Up to 42 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).

  3. Total Annualized SCS Exposure Over the Treatment Period

    Time frame: Up to 42 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.

  4. Asthma Control Questionnaire-5 (ACQ-5) Response

    Time frame: 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.

  5. Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)

    Time frame: 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.

  6. Number of Participants with at Least One Adverse Event

    Time frame: Up to 42 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.

  7. Number of Participants with at Least One Serious Adverse Event

    Time frame: Up to 42 months

  8. Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events

    Time frame: Up to 42 months

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Fixed-Dose Combination on Severe Asthma Exacerbations in Patients With Asthma

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2023
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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