A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. · Sep 18, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a new combination inhaler, which includes fluticasone propionate and albuterol sulfate, can help prevent severe asthma attacks better than using albuterol alone. The trial is looking for participants aged 14 to 60 who have had asthma for at least a year and have experienced at least one serious asthma attack in the past year. To join the study, participants must be using their prescribed asthma medication at a stable dose and must not be pregnant or breastfeeding.
Participants in the trial can expect to be involved for a minimum of 28 weeks, which includes a screening period and a treatment phase where they will receive either the new combination inhaler or the standard inhaler without knowing which one they're getting. This is called a double-blind study, meaning neither the participants nor the researchers know who receives which treatment. Throughout the study, researchers will monitor how well the inhaler works in preventing asthma attacks and check for any side effects. If you think you might be eligible and are interested in participating, please reach out to the study team for more information.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • The participant has a documented 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) ending within the past 12 month.
- • 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 smoker and/or has a history of ≥10 pack years history of smoking. A current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months.
- • The participant has significantly abused alcohol and/or illicit 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
About Teva Branded Pharmaceutical Products R&D, Inc.
Teva Branded Pharmaceutical Products R&D, Inc. is a leading global pharmaceutical company dedicated to the research, development, and commercialization of innovative therapeutic solutions. With a strong emphasis on delivering high-quality medicines across various therapeutic areas, Teva leverages its extensive expertise in drug development and manufacturing to advance healthcare outcomes. The company's commitment to scientific excellence and patient-centric approaches drives its clinical trial initiatives, focusing on addressing unmet medical needs and improving the quality of life for patients worldwide. Through robust partnerships and a comprehensive portfolio, Teva continues to play a pivotal role in the pharmaceutical landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pittsburg, Texas, United States
Westminster, California, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Pittsburgh, Pennsylvania, United States
Mckinney, Texas, United States
Banning, California, United States
Westminster, California, United States
Colorado Springs, Colorado, United States
Cutler Bay, Florida, United States
Greenacres City, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Boise, Idaho, United States
Overland Park, Kansas, United States
Lexington, Kentucky, United States
White Marsh, Maryland, United States
Ypsilanti, Michigan, United States
Saint Louis, Missouri, United States
Asheville, North Carolina, United States
Elizabeth City, North Carolina, United States
Cincinnati, Ohio, United States
Tulsa, Oklahoma, United States
Houston, Texas, United States
Paradise Valley, Arizona, United States
Aurora, California, United States
Los Angeles, California, United States
Stockton, California, United States
Cape Coral, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Oldsmar, Florida, United States
Skokie, Illinois, United States
North Charleston, South Carolina, United States
Boerne, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Waxahachie, Texas, United States
Bountiful, Utah, United States
Murray, Utah, United States
Aventura, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Saint Louis, Missouri, United States
Horseheads, New York, United States
High Point, North Carolina, United States
Oklahoma City, Oklahoma, United States
Sherman, Texas, United States
Paradise Valley, Arizona, United States
Aurora, Colorado, United States
Miami, Florida, United States
Miami, Florida, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Leesburg, Florida, United States
Orlando, Florida, United States
Toledo, Ohio, United States
Grants Pass, Oregon, United States
Rock Hill, South Carolina, United States
Dallas, Texas, United States
Greenacres City, Florida, United States
Hialeah, Florida, United States
Orlando, Florida, United States
North Dartmouth, Massachusetts, United States
Greenfield, Wisconsin, United States
Tucson, Arizona, United States
Redondo Beach, California, United States
Englewood, Colorado, United States
Bangor, Maine, United States
New Windsor, New York, United States
Splendora, Texas, United States
Miami, Florida, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
Las Vegas, Nevada, United States
Corsicana, Texas, United States
Houston, Texas, United States
Victoria, Texas, United States
Ajax, Ontario, Canada
Chapel Hill, North Carolina, United States
Kerrville, Texas, United States
Williamsburg, Virginia, United States
Knoxville, Tennessee, United States
El Paso, Texas, United States
Etobicoke, Ontario, Canada
Bakersfield, California, United States
Katy, Texas, United States
Napa, California, United States
Winchester, Ontario, Canada
Houston, Texas, United States
La Palma, California, United States
Northridge, California, United States
Fall River, Massachusetts, United States
Hyde Park, New York, United States
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Vratsa, , Bulgaria
Windsor, Ontario, Canada
Berlin, , Germany
Leipzig Nordost, , Germany
Leipzig, , Germany
Debrecen, , Hungary
Paraparaumu, , New Zealand
South Hastings, , New Zealand
Wellington, , New Zealand
Krakow, , Poland
Spisska Nova Ves, , Slovakia
San Diego, California, United States
San Jose, California, United States
Rockville, Maryland, United States
Flint, Michigan, United States
Chapel Hill, North Carolina, United States
Wilmington, North Carolina, United States
Winston Salem, North Carolina, United States
Austin, Texas, United States
Ruse, , Bulgaria
Sliven, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Jindrichuv Hradec, , Czechia
Lovosice, , Czechia
Augsburg, , Germany
Cottbus, , Germany
Delitzsch, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Munchen, , Germany
Peine, , Germany
Budapest, , Hungary
Budapest, , Hungary
Szigetvar, , Hungary
Rezekne, , Latvia
Riga, , Latvia
Auckland, , New Zealand
Auckland, , New Zealand
Christchurch, , New Zealand
Dunedin, , New Zealand
Rotorua, , New Zealand
Tauranga, , New Zealand
Krakow, , Poland
Makow Podhalanski, , Poland
Ostrowiec Swietokrzyski, , Poland
Poznan, , Poland
Rzeszow, , Poland
Zawadzkie, , Poland
Zilina, , Slovakia
Zilina, , Slovakia
Long Beach, California, United States
Kansas City, Kansas, United States
Saint Louis, Missouri, United States
Hawthorne, New York, United States
Charlotte, North Carolina, United States
Tomball, Texas, United States
South Brisbane, , Australia
Pernik, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Brandys Nad Labem Stara Boleslav, , Czechia
Brno, , Czechia
Jihlava, , Czechia
Ostrava, , Czechia
Varnsdorf, , Czechia
Berlin, , Germany
Heidelberg, , Germany
Munchen, , Germany
Mosonmagyarovar, , Hungary
Pecs, , Hungary
Szeged, , Hungary
Balvi, , Latvia
Daugavpils, , Latvia
Riga, , Latvia
Riga, , Latvia
Hamilton, , New Zealand
Hamilton, , New Zealand
Nelson, , New Zealand
Bialystok, , Poland
Lublin, , Poland
Bardejov, , Slovakia
Kosice, , Slovakia
Rimavska Sobota, , Slovakia
Slovakia, , Slovakia
Benoni, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Johannesburg, , South Africa
Krugersdorp, , South Africa
Middelburg, , South Africa
Midrand, , South Africa
Pretoria, , South Africa
Roodepoort, , South Africa
Stanger, , South Africa
Cordoba, , Spain
San Bernardino, California, United States
Plano, Texas, United States
Midland, , Australia
Kozloduy, , Bulgaria
Edmonton, Alberta, Canada
Prague, , Czechia
Hvidovre, , Denmark
Darmstadt, , Germany
Hannover, , Germany
Mainz A. Rhein, , Germany
Neuss, , Germany
Budapest, , Hungary
Waikanae Beach, , New Zealand
Bialystok, , Poland
Cluj Napoca, , Romania
Craiova, , Romania
Kragujevac, , Serbia
Cape Town, , South Africa
Chatsworth, , South Africa
Durban, , South Africa
Somerset West, , South Africa
Boston, Massachusetts, United States
Nedlands, , Australia
Aalborg, , Denmark
Frankfurt Am Main, , Germany
Hamburg, , Germany
Hamburg, , Germany
Neu Isenburg, , Germany
Petah Tikva, , Israel
Jurmala, , Latvia
Belgrade, , Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Beograd, , Serbia
Beograd, , Serbia
Beograd, , Serbia
Nis, , Serbia
Sremska Kamenica, , Serbia
Ennerdale, , South Africa
Barcelona, , Spain
Long Beach, California, United States
Atlanta, Georgia, United States
Philadelphia, Pennsylvania, United States
Buenos Aires, , Argentina
San Miguel De Tucuman, , Argentina
San Miguel De Tucuman, , Argentina
Bacau, , Romania
Bucuresti, , Romania
Santiago De Compostela, , Spain
College Park, Georgia, United States
Philadelphia, Pennsylvania, United States
Buenos Aires, , Argentina
Capitalfederal, , Argentina
Rosario, , Argentina
Vejle, , Denmark
Verona, , Italy
Bucuresti, , Romania
Valencia, , Spain
Concepcion Del Uruguay, , Argentina
Rosario, , Argentina
San Miguel De Tucuman, , Argentina
Essen, , Germany
Ibbenbueren, , Germany
Witten, , Germany
Beer Sheva, , Israel
Jerusalem, , Israel
Bragadiru, , Romania
Plettenberg Bay, , South Africa
Madrid, , Spain
Rosario, , Argentina
San Miguel De Tucuman, , Argentina
Box Hill, , Australia
Melbourne, , Australia
Berlin, , Germany
Thessaloniki, , Greece
Barcelona, , Spain
Fresno, California, United States
Detroit, Michigan, United States
Caba, , Argentina
Caba, , Argentina
Mendoza, , Argentina
Mendoza, , Argentina
Plovdiv, , Bulgaria
Athens, , Greece
Evros, , Greece
Larissa, , Greece
Petach Tikvah, , Israel
Rehovot, , Israel
Tel Aviv Yafo, , Israel
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Gdansk, , Poland
Cape Town, , South Africa
Sandy, Utah, United States
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Miami, Florida, United States
Miami, Florida, United States
Sweetwater, Florida, United States
Cordoba Capital, , Argentina
Ashkelon, , Israel
Seoul, , Korea, Republic Of
Bydgoszcz, , Poland
Warszawa, , Poland
Margate, Florida, United States
Miami, Florida, United States
Santa Fe, , Argentina
Petah Tikva, , Israel
Rehovot, , Israel
Lodz, , Poland
Doral, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
North Bergen, New Jersey, United States
Ciudad De Mendoza, , Argentina
Mendoza, , Argentina
Quilmes, , Argentina
Hamilton, Ontario, Canada
South Dartmouth, Massachusetts, United States
Bahia Blanca, , Argentina
Pembroke Pines, Florida, United States
Brownsville, Texas, United States
Dallas, Texas, United States
Bahia Blanca, , Argentina
Buenos Aires Province, , Argentina
Ferrara, , Italy
Dothan, Alabama, United States
Colorado Springs, Colorado, United States
Lafayette, Louisiana, United States
Parkville, , Australia
La Jolla, California, United States
Miami, Florida, United States
Yukon, Oklahoma, United States
Lobos, , Argentina
Mar Del Plata, , Argentina
Haifa, , Israel
Jerusalem, , Israel
Krakow, , Poland
Bahia Blanca, , Argentina
Florida, Vicente Lopez, , Argentina
Lanus Este, , Argentina
Statesville, North Carolina, United States
El Paso, Texas, United States
Caba, , Argentina
Florencio Varela, , Argentina
Godoy Cruz, , Argentina
San Fernando, , Argentina
Raslouw, , South Africa
Miami, Florida, United States
Edinburg, Texas, United States
Nawton, , New Zealand
Polokwane, , South Africa
Huntington Beach, California, United States
Parana, , Argentina
San Rafael, , Argentina
Columbus, Ohio, United States
Dayton, Ohio, United States
Caba, , Argentina
Pleven, , Bulgaria
Sofia, , Bulgaria
Riga, , Latvia
Washington, District Of Columbia, United States
Blagoevgrad, , Bulgaria
Sofia, , Bulgaria
Elblag, , Poland
Gdansk, , Poland
Novi Sad, , Serbia
Germiston, , South Africa
Wiesbaden, , Germany
Skierniewice, , Poland
Fresno, California, United States
Beograd, , Serbia
Kansas City, Missouri, United States
Sevilla, , Spain
Jacksonville, Florida, United States
Toledo, Ohio, United States
West Valley City, Utah, United States
North Adelaide, , Australia
Thessaloniki, , Greece
Pisa, , Italy
Verona, , Italy
Sabadell, , Spain
Patients applied
Trial Officials
Teva Medical Expert, MD
Study Director
Teva Branded Pharmaceutical Products R&D, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported