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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06052267
Other study ID # FpA-AS-30094
Secondary ID 2023-505435-12-0
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 30, 2023
Est. completion date July 17, 2026

Study information

Verified date June 2024
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact Teva U.S. Medical Information
Phone 1-888-483-8279
Email USMedInfo@tevapharm.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2196
Est. completion date July 17, 2026
Est. primary completion date July 17, 2026
Accepts healthy volunteers No
Gender All
Age group 4 Years and older
Eligibility 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. 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


Related Conditions & MeSH terms


Intervention

Drug:
TEV-56248
Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Albuterol sulfate
Oral inhalation powder

Locations

Country Name City State
Bulgaria Teva Investigational Site 59224 Sofia
Bulgaria Teva Investigational Site 59220 Stara Zagora
Bulgaria Teva Investigational Site 59229 Vratsa
Canada Teva Investigational Site 11272 Ajax Ontario
Canada Teva Investigational Site 11270 Etobicoke Ontario
Canada Teva Investigational Site 11271 Winchester Ontario
Canada Teva Investigational Site 11273 Windsor Ontario
Germany Teva Investigational Site 32834 Berlin
Germany Teva Investigational Site 32844 Leipzig
Germany Teva Investigational Site 32830 Leipzig - Nordost
Hungary Teva Investigational Site 51342 Debrecen
New Zealand Teva Investigational Site 79058 Paraparaumu
New Zealand Teva Investigational Site 79060 South Hastings
New Zealand Teva Investigational Site 79050 Wellington
Poland Teva Investigational Site 53521 Krakow
Slovakia Teva Investigational Site 62078 Spisska Nova Ves
United States Teva Investigational Site 15618 Asheville North Carolina
United States Teva Investigational Site 15612 Aurora Colorado
United States Teva Investigational Site 15660 Aventura Florida
United States Teva Investigational Site 15685 Bakersfield California
United States Teva Investigational Site 15667 Bangor Maine
United States Teva Investigational Site 15629 Banning California
United States Teva Investigational Site 15641 Boerne Texas
United States Teva Investigational Site 15604 Boise Idaho
United States Teva Investigational Site 15671 Bountiful Utah
United States Teva Investigational Site 15624 Cape Coral Florida
United States Teva Investigational Site 15601 Chapel Hill North Carolina
United States Teva Investigational Site 15669 Chicago Illinois
United States Teva Investigational Site 15607 Cincinnati Ohio
United States Teva Investigational Site 15588 Colorado Springs Colorado
United States Teva Investigational Site 15668 Corsicana Texas
United States Teva Investigational Site 15598 Cutler Bay Florida
United States Teva Investigational Site 15623 Dallas Texas
United States Teva Investigational Site 15637 Dallas Texas
United States Teva Investigational Site 15658 Dallas Texas
United States Teva Investigational Site 15591 El Paso Texas
United States Teva Investigational Site 15678 El Paso Texas
United States Teva Investigational Site 15610 Elizabeth City North Carolina
United States Teva Investigational Site 15676 Englewood Colorado
United States Teva Investigational Site 15674 Evansville Indiana
United States Teva Investigational Site 15686 Fall River Massachusetts
United States Teva Investigational Site 15646 Grants Pass Oregon
United States Teva Investigational Site 15579 Greenacres City Florida
United States Teva Investigational Site 15586 Greenfield Wisconsin
United States Teva Investigational Site 15582 Hialeah Florida
United States Teva Investigational Site 15664 Hialeah Florida
United States Teva Investigational Site 15651 High Point North Carolina
United States Teva Investigational Site 15657 Homestead Florida
United States Teva Investigational Site 15603 Horseheads New York
United States Teva Investigational Site 15578 Houston Texas
United States Teva Investigational Site 15614 Houston Texas
United States Teva Investigational Site 15680 Houston Texas
United States Teva Investigational Site 15696 Houston Texas
United States Teva Investigational Site 15666 Hyde Park New York
United States Teva Investigational Site 15690 Katy Texas
United States Teva Investigational Site 15684 Kerrville Texas
United States Teva Investigational Site 15691 Knoxville Tennessee
United States Teva Investigational Site 15687 La Palma California
United States Teva Investigational Site 15679 Las Vegas Nevada
United States Teva Investigational Site 15632 Leesburg Florida
United States Teva Investigational Site 15627 Lexington Kentucky
United States Teva Investigational Site 15643 Los Angeles California
United States Teva Investigational Site 15630 McKinney Texas
United States Teva Investigational Site 15585 Miami Florida
United States Teva Investigational Site 15592 Miami Florida
United States Teva Investigational Site 15596 Miami Florida
United States Teva Investigational Site 15602 Miami Florida
United States Teva Investigational Site 15605 Miami Florida
United States Teva Investigational Site 15634 Miami Florida
United States Teva Investigational Site 15639 Miami Florida
United States Teva Investigational Site 15644 Miami Florida
United States Teva Investigational Site 15652 Miami Florida
United States Teva Investigational Site 15654 Miami Florida
United States Teva Investigational Site 15655 Miami Florida
United States Teva Investigational Site 15589 Miami Lakes Florida
United States Teva Investigational Site 15595 Miami Lakes Florida
United States Teva Investigational Site 15599 Miami Lakes Florida
United States Teva Investigational Site 15635 Murray Utah
United States Teva Investigational Site 15695 Napa California
United States Teva Investigational Site 15675 New Windsor New York
United States Teva Investigational Site 15608 North Charleston South Carolina
United States Teva Investigational Site 15663 North Dartmouth Massachusetts
United States Teva Investigational Site 15692 Northridge California
United States Teva Investigational Site 15577 Oklahoma City Oklahoma
United States Teva Investigational Site 15665 Oldsmar Florida
United States Teva Investigational Site 15617 Orlando Florida
United States Teva Investigational Site 15625 Orlando Florida
United States Teva Investigational Site 15659 Orlando Florida
United States Teva Investigational Site 15580 Overland Park Kansas
United States Teva Investigational Site 15581 Paradise Valley Arizona
United States Teva Investigational Site 15597 Pembroke Pines Florida
United States Teva Investigational Site 15576 Pittsburgh Pennsylvania
United States Teva Investigational Site 15682 Redondo Beach California
United States Teva Investigational Site 15672 Rock Hill South Carolina
United States Teva Investigational Site 15633 Saint Louis Missouri
United States Teva Investigational Site 15650 Saint Louis Missouri
United States Teva Investigational Site 15638 San Antonio Texas
United States Teva Investigational Site 15656 San Antonio Texas
United States Teva Investigational Site 15670 San Antonio Texas
United States Teva Investigational Site 15626 Savannah Georgia
United States Teva Investigational Site 15647 Sherman Texas
United States Teva Investigational Site 15600 Skokie Illinois
United States Teva Investigational Site 15673 Splendora Texas
United States Teva Investigational Site 15620 Stockton California
United States Teva Investigational Site 15587 Tamarac Florida
United States Teva Investigational Site 15611 Tampa Florida
United States Teva Investigational Site 15619 Tampa Florida
United States Teva Investigational Site 15653 Tampa Florida
United States Teva Investigational Site 15662 Toledo Ohio
United States Teva Investigational Site 15661 Tucson Arizona
United States Teva Investigational Site 15594 Tulsa Oklahoma
United States Teva Investigational Site 15693 Victoria Texas
United States Teva Investigational Site 15649 Waxahachie Texas
United States Teva Investigational Site 15621 Westminster California
United States Teva Investigational Site 15583 White Marsh Maryland
United States Teva Investigational Site 15683 Williamsburg Virginia
United States Teva Investigational Site 15606 Winter Park Florida
United States Teva Investigational Site 15593 Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Germany,  Hungary,  New Zealand,  Poland,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to First Severe Clinical Asthma Exacerbation (CAE) Up to 35 months
Secondary Annualized Severe CAE Rate 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). Up to 35 months
Secondary Total Annualized SCS Exposure Over the Treatment Period 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. Up to 35 months
Secondary Asthma Control Questionnaire-5 (ACQ-5) Response 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.
Baseline, Week 24
Secondary Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ) 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.
Baseline, Week 24
Secondary Number of Participants with at Least One Adverse Event 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. Up to 35 months
Secondary Number of Participants with at Least One Serious Adverse Event Up to 35 months
Secondary Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events Up to 35 months
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