Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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 78127 - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Pernik
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Ruse
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Sliven
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Stara Zagora
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Varna
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Vratsa
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Czechia
State/province [37] 0 0
Brandys Nad Labem-stara Boleslav
Country [38] 0 0
Czechia
State/province [38] 0 0
Brno
Country [39] 0 0
Czechia
State/province [39] 0 0
Jihlava
Country [40] 0 0
Czechia
State/province [40] 0 0
Jindrichuv Hradec
Country [41] 0 0
Czechia
State/province [41] 0 0
Lovosice
Country [42] 0 0
Czechia
State/province [42] 0 0
Ostrava
Country [43] 0 0
Czechia
State/province [43] 0 0
Varnsdorf
Country [44] 0 0
Germany
State/province [44] 0 0
Augsburg
Country [45] 0 0
Germany
State/province [45] 0 0
Berlin
Country [46] 0 0
Germany
State/province [46] 0 0
Cottbus
Country [47] 0 0
Germany
State/province [47] 0 0
Delitzsch
Country [48] 0 0
Germany
State/province [48] 0 0
Frankfurt
Country [49] 0 0
Germany
State/province [49] 0 0
Hamburg
Country [50] 0 0
Germany
State/province [50] 0 0
Heidelberg
Country [51] 0 0
Germany
State/province [51] 0 0
Leipzig - Nordost
Country [52] 0 0
Germany
State/province [52] 0 0
Leipzig
Country [53] 0 0
Germany
State/province [53] 0 0
Munchen
Country [54] 0 0
Germany
State/province [54] 0 0
Peine
Country [55] 0 0
Hungary
State/province [55] 0 0
Budapest
Country [56] 0 0
Hungary
State/province [56] 0 0
Debrecen
Country [57] 0 0
Hungary
State/province [57] 0 0
Mosonmagyarovar
Country [58] 0 0
Hungary
State/province [58] 0 0
Pecs
Country [59] 0 0
Hungary
State/province [59] 0 0
Szeged
Country [60] 0 0
Hungary
State/province [60] 0 0
Szigetvar
Country [61] 0 0
Latvia
State/province [61] 0 0
Balvi
Country [62] 0 0
Latvia
State/province [62] 0 0
Daugavpils
Country [63] 0 0
Latvia
State/province [63] 0 0
Rezekne
Country [64] 0 0
Latvia
State/province [64] 0 0
Riga
Country [65] 0 0
New Zealand
State/province [65] 0 0
Auckland
Country [66] 0 0
New Zealand
State/province [66] 0 0
Christchurch
Country [67] 0 0
New Zealand
State/province [67] 0 0
Dunedin
Country [68] 0 0
New Zealand
State/province [68] 0 0
Hamilton
Country [69] 0 0
New Zealand
State/province [69] 0 0
Nelson
Country [70] 0 0
New Zealand
State/province [70] 0 0
Paraparaumu
Country [71] 0 0
New Zealand
State/province [71] 0 0
Rotorua
Country [72] 0 0
New Zealand
State/province [72] 0 0
South Hastings
Country [73] 0 0
New Zealand
State/province [73] 0 0
Tauranga
Country [74] 0 0
New Zealand
State/province [74] 0 0
Wellington
Country [75] 0 0
Poland
State/province [75] 0 0
Bialystok
Country [76] 0 0
Poland
State/province [76] 0 0
Krakow
Country [77] 0 0
Poland
State/province [77] 0 0
Lublin
Country [78] 0 0
Poland
State/province [78] 0 0
Makow Podhalanski
Country [79] 0 0
Poland
State/province [79] 0 0
Ostrowiec Swietokrzyski
Country [80] 0 0
Poland
State/province [80] 0 0
Poznan
Country [81] 0 0
Poland
State/province [81] 0 0
Rzeszow
Country [82] 0 0
Poland
State/province [82] 0 0
Zawadzkie
Country [83] 0 0
Slovakia
State/province [83] 0 0
Bardejov
Country [84] 0 0
Slovakia
State/province [84] 0 0
Kosice
Country [85] 0 0
Slovakia
State/province [85] 0 0
Rimavska Sobota
Country [86] 0 0
Slovakia
State/province [86] 0 0
Slovakia
Country [87] 0 0
Slovakia
State/province [87] 0 0
Spisska Nova Ves
Country [88] 0 0
Slovakia
State/province [88] 0 0
Zilina
Country [89] 0 0
South Africa
State/province [89] 0 0
Benoni
Country [90] 0 0
South Africa
State/province [90] 0 0
Cape Town
Country [91] 0 0
South Africa
State/province [91] 0 0
Cape town
Country [92] 0 0
South Africa
State/province [92] 0 0
Johannesburg
Country [93] 0 0
South Africa
State/province [93] 0 0
Krugersdorp
Country [94] 0 0
South Africa
State/province [94] 0 0
Middelburg
Country [95] 0 0
South Africa
State/province [95] 0 0
Midrand
Country [96] 0 0
South Africa
State/province [96] 0 0
Pretoria
Country [97] 0 0
South Africa
State/province [97] 0 0
Roodepoort
Country [98] 0 0
South Africa
State/province [98] 0 0
Stanger
Country [99] 0 0
Spain
State/province [99] 0 0
Cordoba

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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