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A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma
NCT06664619 · Teva Branded Pharmaceutical Products R&D, Inc.
In plain English
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Official title
A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Fluticasone Propionate/Albuterol Sulfate Combination Compared to Fluticasone Propionate, Albuterol Sulfate or Placebo Delivered by Multidose Dry Powder Inhaler in Participants 12 Years and Older With Asthma
About this study
The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI).
Secondary objectives are:
* To evaluate the efficacy of Fp/ABS eMDPI administered four times daily
* To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks
* To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose
The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.
Eligibility criteria
Inclusion Criteria:
* The participant has a diagnosis of asthma of at least 6 months duration.
* Participants currently receive a beta-agonist (eg, salbutamol \[albuterol\] or ICS albuterol or ICS-formoterol) as rescue medication with or without asthma controller medication.
* If female, a 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 trial), or is of non-childbearing potential.
NOTE- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
* The participant has a history of life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest, hypoxic seizures or an asthma related syncopal episode.
* The participant has had an upper or lower respiratory tract infection within 2 weeks or has had a confirmed case of COVID-19 within 6 weeks prior to Visit 1. Symptoms of the infection(s) must be completely resolved prior to entering 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, or any orally inhaled products including but not limited to cigarettes, beedis, vaping/ e-cigarettes, hookah/waterpipes, or marijuana. Note: participants with a positive urinary cotinine test will be excluded.
* The participant has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, pulmonary fibrosis), or participants with a diagnosis of asthma COPD overlap syndrome.
NOTE- Additional criteria apply, please contact the investigator for more information
Study design
Enrollment target: 724 participants
Allocation: randomized
Masking: quadruple
Age groups: child, adult, older_adult
Timeline
Starts: 2024-12-12
Estimated completion: 2026-05-31
Last updated: 2026-04-02
Interventions
Drug: Fp/ABSDrug: FPDrug: ABSDrug: Placebo
Primary outcomes
- • Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks (Baseline, Week 4)
- • Change from Baseline trough FEV1 at week 4 (Baseline, Week 4)
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. · industry
Contacts & investigators
ContactTeva U.S. Medical Information · contact · USMedInfo@tevapharm.com · 1-888-483-8279
InvestigatorTeva Medical Expert, MD · study_director, Teva Branded Pharmaceutical Products R&D, Inc.
All locations (140)
Teva Investigational Site 12087Recruiting
Phoenix, Arizona, United States
Teva Investigational Site 12144Completed
Phoenix, Arizona, United States
Teva Investigational Site 12104Completed
Tucson, Arizona, United States
Teva Investigational Site 12146Recruiting
Tucson, Arizona, United States
Teva Investigational Site 12102Recruiting
Little Rock, Arkansas, United States
Teva Investigational Site 12154Recruiting
Encinitas, California, United States
Teva Investigational Site 12103Recruiting
Huntington Beach, California, United States
Teva Investigational Site 12068Recruiting
La Palma, California, United States
Teva Investigational Site 12152Recruiting
Laguna Niguel, California, United States
Teva Investigational Site 12145Recruiting
Long Beach, California, United States
Teva Investigational Site 12088Recruiting
Los Angeles, California, United States
Teva Investigational Site 12094Recruiting
Los Angeles, California, United States
Teva Investigational Site 12161Recruiting
Northridge, California, United States
Teva Investigational Site 12105Recruiting
Oxnard, California, United States
Teva Investigational Site 12101Recruiting
Sacramento, California, United States
Teva Investigational Site 12064Recruiting
San Jose, California, United States
Teva Investigational Site 12109Completed
Upland, California, United States
Teva Investigational Site 12070Completed
Vista, California, United States
Teva Investigational Site 12091Recruiting
Walnut Creek, California, United States
Teva Investigational Site 12142Recruiting
Lakewood, Colorado, United States
Teva Investigational Site 12098Completed
Lake City, Florida, United States
Teva Investigational Site 12118Completed
Lake Worth, Florida, United States
Teva Investigational Site 12079Recruiting
Melbourne, Florida, United States
Teva Investigational Site 12071Recruiting
Miami, Florida, United States
Teva Investigational Site 12074Recruiting
Miami, Florida, United States
Teva Investigational Site 12086Recruiting
Miami, Florida, United States
Teva Investigational Site 12061Completed
Miami, Florida, United States
Teva Investigational Site 12097Recruiting
Miami, Florida, United States
Teva Investigational Site 12092Completed
Miami Lakes, Florida, United States
Teva Investigational Site 12076Completed
North Miami Beach, Florida, United States
Teva Investigational Site 12095Recruiting
Palmetto Bay, Florida, United States
Teva Investigational Site 12075Recruiting
Pompano Beach, Florida, United States
Teva Investigational Site 12078Recruiting
Tampa, Florida, United States
Teva Investigational Site 12175Recruiting
Conyers, Georgia, United States
Teva Investigational Site 12156Recruiting
Boise, Idaho, United States
Teva Investigational Site 12162Recruiting
Westchester, Illinois, United States
Teva Investigational Site 12081Completed
Nottingham, Maryland, United States
Teva Investigational Site 12106Recruiting
Towson, Maryland, United States
Teva Investigational Site 12157Recruiting
White Marsh, Maryland, United States
Teva Investigational Site 12119Recruiting
Boston, Massachusetts, United States
Teva Investigational Site 12073Completed
Minneapolis, Minnesota, United States
Teva Investigational Site 12066Recruiting
Richfield, Minnesota, United States
Teva Investigational Site 12149Recruiting
Columbia, Missouri, United States
Teva Investigational Site 12108Recruiting
St Louis, Missouri, United States
Teva Investigational Site 12089Recruiting
St Louis, Missouri, United States
Teva Investigational Site 12158Recruiting
Hastings, Nebraska, United States
Teva Investigational Site 12160Recruiting
Las Vegas, Nevada, United States
Teva Investigational Site 12150Recruiting
Las Vegas, Nevada, United States
Teva Investigational Site 12110Recruiting
Jersey City, New Jersey, United States
Teva Investigational Site 12115Recruiting
Charlotte, North Carolina, United States
Teva Investigational Site 12085Recruiting
Raleigh, North Carolina, United States
Teva Investigational Site 12063Recruiting
Toledo, Ohio, United States
Teva Investigational Site 12155Recruiting
Tulsa, Oklahoma, United States
Teva Investigational Site 12170Recruiting
Tulsa, Oklahoma, United States
Teva Investigational Site 12117Completed
Clackamas, Oregon, United States
Teva Investigational Site 12151Recruiting
Portland, Oregon, United States
Teva Investigational Site 12147Completed
Horsham, Pennsylvania, United States
Teva Investigational Site 12072Recruiting
Philadelphia, Pennsylvania, United States
Teva Investigational Site 12114Recruiting
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 12067Completed
Columbia, South Carolina, United States
Teva Investigational Site 12111Completed
Myrtle Beach, South Carolina, United States
Teva Investigational Site 12112Completed
North Charleston, South Carolina, United States
Teva Investigational Site 12107Recruiting
Rock Hill, South Carolina, United States
Teva Investigational Site 12083Recruiting
Austin, Texas, United States
Teva Investigational Site 12060Recruiting
Austin, Texas, United States
Teva Investigational Site 12077Completed
Corsicana, Texas, United States
Teva Investigational Site 12159Recruiting
Dallas, Texas, United States
Teva Investigational Site 12090Recruiting
Dallas, Texas, United States
Teva Investigational Site 12143Recruiting
El Paso, Texas, United States
Teva Investigational Site 12080Completed
Kingwood, Texas, United States
Teva Investigational Site 12096Recruiting
McKinney, Texas, United States
Teva Investigational Site 12113Recruiting
Mesquite, Texas, United States
Teva Investigational Site 12084Recruiting
Victoria, Texas, United States
Teva Investigational Site 12148Recruiting
Pleasant View, Utah, United States
Teva Investigational Site 12082Completed
Salt Lake City, Utah, United States
Teva Investigational Site 12153Recruiting
South Ogden, Utah, United States
Teva Investigational Site 12093Completed
Portsmouth, Virginia, United States
Teva Investigational Site 12062Recruiting
Greenfield, Wisconsin, United States
Teva Investigational Site 20154Recruiting
Buenos Aires, Argentina
Teva Investigational Site 20156Recruiting
Buenos Aires, Argentina
Teva Investigational Site 20157Recruiting
Córdoba, Argentina
Teva Investigational Site 20150Recruiting
Córdoba, Argentina
Teva Investigational Site 20145Recruiting
Mar del Plata, Argentina
Teva Investigational Site 20151Recruiting
Mar del Plata, Argentina
Teva Investigational Site 20146Recruiting
Quilmes, Argentina
Teva Investigational Site 20148Recruiting
Rosario, Argentina
Teva Investigational Site 20155Recruiting
Rosario, Argentina
Teva Investigational Site 20147Recruiting
San Juan Bautista, Argentina
Teva Investigational Site 20152Recruiting
San Miguel de Tucumán, Argentina
Teva Investigational Site 20149Recruiting
San Miguel de Tucumán, Argentina
Teva Investigational Site 59248Recruiting
Haskovo, Bulgaria
Teva Investigational Site 59251Recruiting
Lovech, Bulgaria
Teva Investigational Site 59249Recruiting
Montana, Bulgaria
Teva Investigational Site 59247Completed
Pleven, Bulgaria
Teva Investigational Site 59256Recruiting
Sliven, Bulgaria
Teva Investigational Site 59246Recruiting
Sofia, Bulgaria
Teva Investigational Site 59252Recruiting
Sofia, Bulgaria
Teva Investigational Site 59253Completed
Sofia, Bulgaria
Teva Investigational Site 59245Recruiting
Stara Zagora, Bulgaria
Teva Investigational Site 59254Recruiting
Veliko Tarnovo, Bulgaria
Teva Investigational Site 59250Recruiting
Vratsa, Bulgaria
Teva Investigational Site 54245Recruiting
Jindřichův Hradec, Czechia
Teva Investigational Site 54244Recruiting
Teplice, Czechia
Teva Investigational Site 54243Recruiting
Varnsdorf, Czechia
Teva Investigational Site 32881Recruiting
Ahrensburg, Germany
Teva Investigational Site 32880Recruiting
Bendorf, Germany
Teva Investigational Site 32884Recruiting
Berlin, Germany
Teva Investigational Site 32886Recruiting
Berlin, Germany
Teva Investigational Site 32879Recruiting
Frankfurt, Germany
Teva Investigational Site 32887Recruiting
Leipzig, Germany
Teva Investigational Site 32883Completed
Leipzig, Germany
Teva Investigational Site 32876Recruiting
Leipzig, Germany
Teva Investigational Site 32877Recruiting
Magdeburg, Germany
Teva Investigational Site 32878Recruiting
Mainz A. Rhein, Germany
Teva Investigational Site 32888Recruiting
Neu-Isenburg, Germany
Teva Investigational Site 32882Recruiting
Rheine, Germany
Teva Investigational Site 80207Completed
Be’er Ya‘aqov, Israel
Teva Investigational Site 80206Recruiting
Haifa, Israel
Teva Investigational Site 80208Recruiting
Jerusalem, Israel
Teva Investigational Site 21133Recruiting
Chihuahua City, Mexico
Teva Investigational Site 21134Recruiting
Mexico City, Mexico
Teva Investigational Site 21137Recruiting
Morelia, Mexico
Teva Investigational Site 21136Recruiting
Tlalnepantla, Mexico
Teva Investigational Site 21135Recruiting
Zapopan, Mexico
Teva Investigational Site 53578Completed
Gdansk, Poland
Teva Investigational Site 53575Recruiting
Lodz, Poland
Teva Investigational Site 53576Completed
Lodz, Poland
Teva Investigational Site 53579Recruiting
Poznan, Poland
Teva Investigational Site 53574Recruiting
Tarnów, Poland
Teva Investigational Site 53577Recruiting
Wroclaw, Poland
Teva Investigational Site 52148Recruiting
Craiova, Romania
Teva Investigational Site 52147Recruiting
Oradea, Romania
Teva Investigational Site 52145Recruiting
Timișoara, Romania
Teva Investigational Site 62102Recruiting
Košice, Slovakia
Teva Investigational Site 62103Completed
Martin, Slovakia
Teva Investigational Site 62101Recruiting
Spišská Nová Ves, Slovakia
Teva Investigational Site 82089Recruiting
Adana, Turkey (Türkiye)
Teva Investigational Site 82085Recruiting
Kirikkale, Turkey (Türkiye)
Teva Investigational Site 82088Recruiting
Kocaeli, Turkey (Türkiye)
Teva Investigational Site 82087Recruiting
Mersin, Turkey (Türkiye)