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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
Date last updated
26/11/2024

Titles & IDs
Public title
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
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
Secondary ID [1] 0 0
2023-505435-12-00
Secondary ID [2] 0 0
FpA-AS-30094
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Severe Clinical Asthma Exacerbation (CAE)
Timepoint [1] 0 0
Up to 35 months
Secondary outcome [1] 0 0
Annualized Severe CAE Rate
Timepoint [1] 0 0
Up to 35 months
Secondary outcome [2] 0 0
Total Annualized SCS Exposure Over the Treatment Period
Timepoint [2] 0 0
Up to 35 months
Secondary outcome [3] 0 0
Asthma Control Questionnaire-5 (ACQ-5) Response
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Number of Participants with at Least One Adverse Event
Timepoint [5] 0 0
Up to 35 months
Secondary outcome [6] 0 0
Number of Participants with at Least One Serious Adverse Event
Timepoint [6] 0 0
Up to 35 months
Secondary outcome [7] 0 0
Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events
Timepoint [7] 0 0
Up to 35 months

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.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/07/2026
Actual
Sample size
Target
2196
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 78131 - Box Hill
Recruitment hospital [2] 0 0
Teva Investigational Site 78133 - Melbourne
Recruitment hospital [3] 0 0
Teva Investigational Site 78132 - Midland
Recruitment hospital [4] 0 0
Teva Investigational Site 78130 - Nedlands
Recruitment hospital [5] 0 0
Teva Investigational Site 78127 - South Brisbane
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6056 - Midland
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment outside Australia
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Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06052267
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Teva Medical Expert, MD
Address 0 0
Teva Branded Pharmaceutical Products R&D, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Teva U.S. Medical Information
Address 0 0
Country 0 0
Phone 0 0
1-888-483-8279
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06052267