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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06052267
Registration number
NCT06052267
Ethics application status
Date submitted
18/09/2023
Date registered
25/09/2023
Titles & IDs
Public title
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
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Scientific 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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Secondary ID [1]
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2023-505435-12-00
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Secondary ID [2]
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FpA-AS-30094
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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0
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Condition category
Condition code
Respiratory
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0
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TEV-56248
Treatment: Drugs - Albuterol sulfate
Experimental: TEV-56248 Low Dose - 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.
Experimental: TEV-56248 High Dose - 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.
Active comparator: 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.
Treatment: Drugs: TEV-56248
Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Treatment: Drugs: Albuterol sulfate
Oral inhalation powder
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to First Severe Clinical Asthma Exacerbation (CAE)
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Assessment method [1]
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0
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Timepoint [1]
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Up to 35 months
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Secondary outcome [1]
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Annualized Severe CAE Rate
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Assessment method [1]
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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).
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Timepoint [1]
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Up to 35 months
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Secondary outcome [2]
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Total Annualized SCS Exposure Over the Treatment Period
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 35 months
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Secondary outcome [3]
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Asthma Control Questionnaire-5 (ACQ-5) Response
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Week 24
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Secondary outcome [4]
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Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Week 24
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Secondary outcome [5]
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Number of Participants with at Least One Adverse Event
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 35 months
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Secondary outcome [6]
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Number of Participants with at Least One Serious Adverse Event
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Assessment method [6]
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Timepoint [6]
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Up to 35 months
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Secondary outcome [7]
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Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events
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Assessment method [7]
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Timepoint [7]
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Up to 35 months
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Eligibility
Key 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.
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Minimum age
4
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/08/2023
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Date of last participant enrolment
Anticipated
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Date of last data collection
Anticipated
17/07/2026
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Actual
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Sample size
Target
2196
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Teva Investigational Site 78127 - South Brisbane
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Teva Branded Pharmaceutical Products R&D, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06052267
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Teva Medical Expert, MD
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Teva Branded Pharmaceutical Products R&D, Inc.
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Teva U.S. Medical Information
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Phone
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1-888-483-8279
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit www.clinicalstudydatarequest.com to make your request.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06052267