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

Asthma Clinical Trial

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

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
• 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
• 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

Related Conditions & MeSH terms

• Asthma

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