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

NCT06052267
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
2,772
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Lead sponsor
Teva Branded Pharmaceutical Products R&D LLC
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Start date
2023-08-30
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Number of sites
393
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Summary
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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Short title
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
clinicaltrials.gov
Official 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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-10-31
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First posted
2023-09-25
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Registry last updated
2026-07-24
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Primary completion date
2026-10-31
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Start date
2023-08-30
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Actual participants
2,772
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Participants
2,772
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
393
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Teva Branded Pharmaceutical Products R&D LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06052267
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ClinicalTrials.gov ID
NCT06052267
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: Up to 42 months

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

    Timeframe: Up to 42 months

  2. Annualized Severe CAE Rate

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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

    Timeframe: Up to 42 months

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

    Timeframe: Up to 42 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
4 Years
Healthy volunteers
No

  • 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.

  • 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

Sources for eligibility
clinicaltrials.gov

  • Teva Investigational Site 15706Birmingham, United States
  • Teva Investigational Site 15786Birmingham, United States
  • Teva Investigational Site 15768Dothan, United States
  • Teva Investigational Site 15581Paradise Valley, United States
  • Teva Investigational Site 15710Scottsdale, United States
  • Teva Investigational Site 15661Tucson, United States
  • Teva Investigational Site 15685Bakersfield, United States
  • Teva Investigational Site 15721Fresno, United States
  • Teva Investigational Site 15788Huntington Beach, United States
  • Teva Investigational Site 15720La Jolla, United States
  • Teva Investigational Site 15687La Palma, United States
  • Teva Investigational Site 15708Long Beach, United States
  • Teva Investigational Site 15712Long Beach, United States
  • Teva Investigational Site 15643Los Angeles, United States
  • Teva Investigational Site 15695Napa, United States
  • Teva Investigational Site 15692Northridge, United States
  • Teva Investigational Site 15682Redondo Beach, United States
  • Teva Investigational Site 15629San Bernardino, United States
  • Teva Investigational Site 15709San Diego, United States
  • Teva Investigational Site 15704San Jose, United States
  • Teva Investigational Site 15620Stockton, United States
  • Teva Investigational Site 15621Westminster, United States
  • Teva Investigational Site 15612Aurora, United States
  • Teva Investigational Site 15588Colorado Springs, United States
  • Teva Investigational Site 15765Colorado Springs, United States

And 368 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-505435-12-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)