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
NCT ID: NCT06664619
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
724 participants
INTERVENTIONAL
2024-12-12
2026-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fp/ABS eMDPI
Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module
Fp/ABS
Inhalation powder
Fp eMDPI
Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)
FP
Inhalation powder
ABS eMDPI
Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)
ABS
Inhalation powder
Placebo eMDPI
Placebo
Inhalation powder
Interventions
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Fp/ABS
Inhalation powder
FP
Inhalation powder
ABS
Inhalation powder
Placebo
Inhalation powder
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
12 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 12087
Phoenix, Arizona, United States
Teva Investigational Site 12144
Phoenix, Arizona, United States
Teva Investigational Site 12104
Tucson, Arizona, United States
Teva Investigational Site 12146
Tucson, Arizona, United States
Teva Investigational Site 12102
Little Rock, Arkansas, United States
Teva Investigational Site 12154
Encinitas, California, United States
Teva Investigational Site 12103
Huntington Beach, California, United States
Teva Investigational Site 12068
La Palma, California, United States
Teva Investigational Site 12152
Laguna Niguel, California, United States
Teva Investigational Site 12145
Long Beach, California, United States
Teva Investigational Site 12088
Los Angeles, California, United States
Teva Investigational Site 12094
Los Angeles, California, United States
Teva Investigational Site 12161
Northridge, California, United States
Teva Investigational Site 12105
Oxnard, California, United States
Teva Investigational Site 12101
Sacramento, California, United States
Teva Investigational Site 12064
San Jose, California, United States
Teva Investigational Site 12109
Upland, California, United States
Teva Investigational Site 12070
Vista, California, United States
Teva Investigational Site 12091
Walnut Creek, California, United States
Teva Investigational Site 12142
Lakewood, Colorado, United States
Teva Investigational Site 12098
Lake City, Florida, United States
Teva Investigational Site 12118
Lake Worth, Florida, United States
Teva Investigational Site 12079
Melbourne, Florida, United States
Teva Investigational Site 12071
Miami, Florida, United States
Teva Investigational Site 12074
Miami, Florida, United States
Teva Investigational Site 12086
Miami, Florida, United States
Teva Investigational Site 12061
Miami, Florida, United States
Teva Investigational Site 12097
Miami, Florida, United States
Teva Investigational Site 12092
Miami Lakes, Florida, United States
Teva Investigational Site 12076
North Miami Beach, Florida, United States
Teva Investigational Site 12095
Palmetto Bay, Florida, United States
Teva Investigational Site 12075
Pompano Beach, Florida, United States
Teva Investigational Site 12078
Tampa, Florida, United States
Teva Investigational Site 12156
Boise, Idaho, United States
Teva Investigational Site 12162
Westchester, Illinois, United States
Teva Investigational Site 12081
Nottingham, Maryland, United States
Teva Investigational Site 12106
Towson, Maryland, United States
Teva Investigational Site 12157
White Marsh, Maryland, United States
Teva Investigational Site 12119
Boston, Massachusetts, United States
Teva Investigational Site 12073
Minneapolis, Minnesota, United States
Teva Investigational Site 12066
Richfield, Minnesota, United States
Teva Investigational Site 12149
Columbia, Missouri, United States
Teva Investigational Site 12108
St Louis, Missouri, United States
Teva Investigational Site 12089
St Louis, Missouri, United States
Teva Investigational Site 12158
Hastings, Nebraska, United States
Teva Investigational Site 12160
Las Vegas, Nevada, United States
Teva Investigational Site 12150
Las Vegas, Nevada, United States
Teva Investigational Site 12110
Jersey City, New Jersey, United States
Teva Investigational Site 12115
Charlotte, North Carolina, United States
Teva Investigational Site 12085
Raleigh, North Carolina, United States
Teva Investigational Site 12063
Toledo, Ohio, United States
Teva Investigational Site 12155
Tulsa, Oklahoma, United States
Teva Investigational Site 12117
Clackamas, Oregon, United States
Teva Investigational Site 12151
Portland, Oregon, United States
Teva Investigational Site 12147
Horsham, Pennsylvania, United States
Teva Investigational Site 12072
Philadelphia, Pennsylvania, United States
Teva Investigational Site 12114
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 12067
Columbia, South Carolina, United States
Teva Investigational Site 12111
Myrtle Beach, South Carolina, United States
Teva Investigational Site 12112
North Charleston, South Carolina, United States
Teva Investigational Site 12107
Rock Hill, South Carolina, United States
Teva Investigational Site 12083
Austin, Texas, United States
Teva Investigational Site 12060
Austin, Texas, United States
Teva Investigational Site 12077
Corsicana, Texas, United States
Teva Investigational Site 12090
Dallas, Texas, United States
Teva Investigational Site 12159
Dallas, Texas, United States
Teva Investigational Site 12143
El Paso, Texas, United States
Teva Investigational Site 12080
Kingwood, Texas, United States
Teva Investigational Site 12096
McKinney, Texas, United States
Teva Investigational Site 12113
Mesquite, Texas, United States
Teva Investigational Site 12084
Victoria, Texas, United States
Teva Investigational Site 12148
Pleasant View, Utah, United States
Teva Investigational Site 12082
Salt Lake City, Utah, United States
Teva Investigational Site 12153
South Ogden, Utah, United States
Teva Investigational Site 12093
Portsmouth, Virginia, United States
Teva Investigational Site 12062
Greenfield, Wisconsin, United States
Teva Investigational Site 20154
Buenos Aires, , Argentina
Teva Investigational Site 20150
Córdoba, , Argentina
Teva Investigational Site 20145
Mar del Plata, , Argentina
Teva Investigational Site 20151
Mar del Plata, , Argentina
Teva Investigational Site 20146
Quilmes, , Argentina
Teva Investigational Site 20148
Rosario, , Argentina
Teva Investigational Site 20155
Rosario, , Argentina
Teva Investigational Site 20152
San Miguel de Tucumán, , Argentina
Teva Investigational Site 20149
San Miguel de Tucumán, , Argentina
Teva Investigational Site 59248
Haskovo, , Bulgaria
Teva Investigational Site 59251
Lovech, , Bulgaria
Teva Investigational Site 59249
Montana, , Bulgaria
Teva Investigational Site 59247
Pleven, , Bulgaria
Teva Investigational Site 59246
Sofia, , Bulgaria
Teva Investigational Site 59252
Sofia, , Bulgaria
Teva Investigational Site 59253
Sofia, , Bulgaria
Teva Investigational Site 59245
Stara Zagora, , Bulgaria
Teva Investigational Site 59254
Veliko Tarnovo, , Bulgaria
Teva Investigational Site 59250
Vratsa, , Bulgaria
Teva Investigational Site 54245
Jindřichův Hradec, , Czechia
Teva Investigational Site 54244
Teplice, , Czechia
Teva Investigational Site 54243
Varnsdorf, , Czechia
Teva Investigational Site 32881
Ahrensburg, , Germany
Teva Investigational Site 32880
Bendorf, , Germany
Teva Investigational Site 32884
Berlin, , Germany
Teva Investigational Site 32879
Frankfurt, , Germany
Teva Investigational Site 32883
Leipzig, , Germany
Teva Investigational Site 32876
Leipzig, , Germany
Teva Investigational Site 32877
Magdeburg, , Germany
Teva Investigational Site 32878
Mainz A. Rhein, , Germany
Teva Investigational Site 32882
Rheine, , Germany
Teva Investigational Site 80207
Be’er Ya‘aqov, , Israel
Teva Investigational Site 80206
Haifa, , Israel
Teva Investigational Site 80208
Jerusalem, , Israel
Teva Investigational Site 21133
Chihuahua City, , Mexico
Teva Investigational Site 21134
Mexico City, , Mexico
Teva Investigational Site 21137
Morelia, , Mexico
Teva Investigational Site 21135
Zapopan, , Mexico
Teva Investigational Site 53578
Gdansk, , Poland
Teva Investigational Site 53575
Lodz, , Poland
Teva Investigational Site 53576
Lodz, , Poland
Teva Investigational Site 53574
Tarnów, , Poland
Teva Investigational Site 53577
Wroclaw, , Poland
Teva Investigational Site 52147
Oradea, , Romania
Teva Investigational Site 52145
Timișoara, , Romania
Teva Investigational Site 62102
Košice, , Slovakia
Teva Investigational Site 62103
Martin, , Slovakia
Teva Investigational Site 62101
Spišská Nová Ves, , Slovakia
Teva Investigational Site 82089
Adana, , Turkey (Türkiye)
Teva Investigational Site 82088
Kocaeli, , Turkey (Türkiye)
Teva Investigational Site 82085
Kırıkkale, , Turkey (Türkiye)
Teva Investigational Site 82087
Mersin, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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2024-517991-39-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
FpA-AS-30093
Identifier Type: -
Identifier Source: org_study_id