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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

Status: Recruiting
Location: See all (171) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Teva Investigational Site 12102
RECRUITING
Little Rock
Arizona
Teva Investigational Site 12087
RECRUITING
Phoenix
Teva Investigational Site 12144
COMPLETED
Phoenix
Teva Investigational Site 12104
COMPLETED
Tucson
Teva Investigational Site 12146
RECRUITING
Tucson
California
Teva Investigational Site 12154
RECRUITING
Encinitas
Teva Investigational Site 12103
RECRUITING
Huntington Beach
Teva Investigational Site 12068
RECRUITING
La Palma
Teva Investigational Site 12152
RECRUITING
Laguna Niguel
Teva Investigational Site 12145
RECRUITING
Long Beach
Teva Investigational Site 12088
RECRUITING
Los Angeles
Teva Investigational Site 12094
RECRUITING
Los Angeles
Teva Investigational Site 12161
RECRUITING
Northridge
Teva Investigational Site 12105
RECRUITING
Oxnard
Teva Investigational Site 12101
RECRUITING
Sacramento
Teva Investigational Site 12064
RECRUITING
San Jose
Teva Investigational Site 12109
COMPLETED
Upland
Teva Investigational Site 12070
COMPLETED
Vista
Teva Investigational Site 12091
RECRUITING
Walnut Creek
Colorado
Teva Investigational Site 12142
RECRUITING
Lakewood
Florida
Teva Investigational Site 12098
COMPLETED
Lake City
Teva Investigational Site 12118
COMPLETED
Lake Worth
Teva Investigational Site 12079
RECRUITING
Melbourne
Teva Investigational Site 12061
COMPLETED
Miami
Teva Investigational Site 12071
RECRUITING
Miami
Teva Investigational Site 12074
RECRUITING
Miami
Teva Investigational Site 12086
RECRUITING
Miami
Teva Investigational Site 12097
RECRUITING
Miami
Teva Investigational Site 12092
COMPLETED
Miami Lakes
Teva Investigational Site 12076
COMPLETED
North Miami Beach
Teva Investigational Site 12095
RECRUITING
Palmetto Bay
Teva Investigational Site 12075
RECRUITING
Pompano Beach
Teva Investigational Site 12078
RECRUITING
Tampa
Georgia
Teva Investigational Site 12175
RECRUITING
Conyers
Idaho
Teva Investigational Site 12156
RECRUITING
Boise
Illinois
Teva Investigational Site 12162
RECRUITING
Westchester
Louisiana
Teva Investigational Site 12169
RECRUITING
Shreveport
Massachusetts
Teva Investigational Site 12119
RECRUITING
Boston
Maryland
Teva Investigational Site 12081
COMPLETED
Nottingham
Teva Investigational Site 12106
RECRUITING
Towson
Teva Investigational Site 12157
RECRUITING
White Marsh
Minnesota
Teva Investigational Site 12073
COMPLETED
Minneapolis
Teva Investigational Site 12066
RECRUITING
Richfield
Missouri
Teva Investigational Site 12149
RECRUITING
Columbia
Teva Investigational Site 12089
RECRUITING
St Louis
Teva Investigational Site 12108
RECRUITING
St Louis
North Carolina
Teva Investigational Site 12115
RECRUITING
Charlotte
Teva Investigational Site 12085
RECRUITING
Raleigh
Nebraska
Teva Investigational Site 12158
RECRUITING
Hastings
New Jersey
Teva Investigational Site 12110
RECRUITING
Jersey City
Nevada
Teva Investigational Site 12150
RECRUITING
Las Vegas
Teva Investigational Site 12160
RECRUITING
Las Vegas
New York
Teva Investigational Site 12167
RECRUITING
Buffalo
Ohio
Teva Investigational Site 12063
RECRUITING
Toledo
Oklahoma
Teva Investigational Site 12178
RECRUITING
Oklahoma City
Teva Investigational Site 12155
RECRUITING
Tulsa
Teva Investigational Site 12170
RECRUITING
Tulsa
Oregon
Teva Investigational Site 12117
COMPLETED
Clackamas
Teva Investigational Site 12151
RECRUITING
Portland
Pennsylvania
Teva Investigational Site 12147
COMPLETED
Horsham
Teva Investigational Site 12072
RECRUITING
Philadelphia
Teva Investigational Site 12114
RECRUITING
Pittsburgh
South Carolina
Teva Investigational Site 12067
COMPLETED
Columbia
Teva Investigational Site 12111
COMPLETED
Myrtle Beach
Teva Investigational Site 12112
COMPLETED
North Charleston
Teva Investigational Site 12107
RECRUITING
Rock Hill
Texas
Teva Investigational Site 12060
RECRUITING
Austin
Teva Investigational Site 12083
RECRUITING
Austin
Teva Investigational Site 12077
COMPLETED
Corsicana
Teva Investigational Site 12179
RECRUITING
Cypress
Teva Investigational Site 12090
RECRUITING
Dallas
Teva Investigational Site 12159
RECRUITING
Dallas
Teva Investigational Site 12171
RECRUITING
Dallas
Teva Investigational Site 12143
RECRUITING
El Paso
Teva Investigational Site 12168
RECRUITING
Houston
Teva Investigational Site 12181
RECRUITING
Houston
Teva Investigational Site 12176
RECRUITING
Kerrville
Teva Investigational Site 12080
COMPLETED
Kingwood
Teva Investigational Site 12096
RECRUITING
Mckinney
Teva Investigational Site 12113
RECRUITING
Mesquite
Teva Investigational Site 12166
RECRUITING
Sugar Land
Teva Investigational Site 12084
RECRUITING
Victoria
Utah
Teva Investigational Site 12148
RECRUITING
Pleasant View
Teva Investigational Site 12082
COMPLETED
Salt Lake City
Teva Investigational Site 12153
RECRUITING
South Ogden
Virginia
Teva Investigational Site 12093
COMPLETED
Portsmouth
Wisconsin
Teva Investigational Site 12062
RECRUITING
Greenfield
Other Locations
Argentina
Teva Investigational Site 20154
RECRUITING
Buenos Aires
Teva Investigational Site 20156
RECRUITING
Buenos Aires
Teva Investigational Site 20150
RECRUITING
Córdoba
Teva Investigational Site 20157
RECRUITING
Córdoba
Teva Investigational Site 20160
RECRUITING
Florida
Teva Investigational Site 20145
RECRUITING
Mar Del Plata
Teva Investigational Site 20151
RECRUITING
Mar Del Plata
Teva Investigational Site 20161
RECRUITING
Mendoza
Teva Investigational Site 20146
RECRUITING
Quilmes
Teva Investigational Site 20148
RECRUITING
Rosario
Teva Investigational Site 20155
RECRUITING
Rosario
Teva Investigational Site 20147
RECRUITING
San Juan Bautista
Teva Investigational Site 20149
RECRUITING
San Miguel De Tucumán
Teva Investigational Site 20152
RECRUITING
San Miguel De Tucumán
Teva Investigational Site 20159
RECRUITING
San Miguel De Tucumán
Teva Investigational Site 20158
RECRUITING
Santa Fe
Bulgaria
Teva Investigational Site 59248
RECRUITING
Haskovo
Teva Investigational Site 59251
RECRUITING
Lovech
Teva Investigational Site 59249
RECRUITING
Montana
Teva Investigational Site 59258
RECRUITING
Montana
Teva Investigational Site 59247
RECRUITING
Pleven
Teva Investigational Site 59259
RECRUITING
Rousse
Teva Investigational Site 59256
RECRUITING
Sliven
Teva Investigational Site 59246
RECRUITING
Sofia
Teva Investigational Site 59252
RECRUITING
Sofia
Teva Investigational Site 59253
COMPLETED
Sofia
Teva Investigational Site 59257
RECRUITING
Sofia
Teva Investigational Site 59245
RECRUITING
Stara Zagora
Teva Investigational Site 59254
RECRUITING
Veliko Tarnovo
Teva Investigational Site 59250
RECRUITING
Vratsa
Germany
Teva Investigational Site 32881
RECRUITING
Ahrensburg
Teva Investigational Site 32880
RECRUITING
Bendorf
Teva Investigational Site 32884
RECRUITING
Berlin
Teva Investigational Site 32886
RECRUITING
Berlin
Teva Investigational Site 32893
RECRUITING
Delitzsch
Teva Investigational Site 32879
RECRUITING
Frankfurt
Teva Investigational Site 32892
RECRUITING
Frankfurt
Teva Investigational Site 32876
RECRUITING
Leipzig
Teva Investigational Site 32883
COMPLETED
Leipzig
Teva Investigational Site 32887
RECRUITING
Leipzig
Teva Investigational Site 32877
RECRUITING
Magdeburg
Teva Investigational Site 32878
RECRUITING
Mainz
Teva Investigational Site 32888
RECRUITING
Neu-isenburg
Teva Investigational Site 32890
RECRUITING
Peine
Teva Investigational Site 32882
RECRUITING
Rheine
Teva Investigational Site 32889
RECRUITING
Witten
Israel
Teva Investigational Site 80207
COMPLETED
Be'er Yaakov
Teva Investigational Site 80206
RECRUITING
Haifa
Teva Investigational Site 80208
RECRUITING
Jerusalem
Mexico
Teva Investigational Site 21133
RECRUITING
Chihuahua City
Teva Investigational Site 21134
RECRUITING
Mexico City
Teva Investigational Site 21137
RECRUITING
Morelia
Teva Investigational Site 21136
RECRUITING
Tlalnepantla
Teva Investigational Site 21135
RECRUITING
Zapopan
Poland
Teva Investigational Site 53580
RECRUITING
Bialystok
Teva Investigational Site 53582
RECRUITING
Bialystok
Teva Investigational Site 53578
COMPLETED
Gdansk
Teva Investigational Site 53575
RECRUITING
Lodz
Teva Investigational Site 53576
COMPLETED
Lodz
Teva Investigational Site 53581
RECRUITING
Maków Podhalański
Teva Investigational Site 53579
RECRUITING
Poznan
Teva Investigational Site 53574
RECRUITING
Tarnów
Teva Investigational Site 53577
RECRUITING
Wroclaw
Romania
Teva Investigational Site 52149
RECRUITING
Bucharest
Teva Investigational Site 52148
RECRUITING
Craiova
Teva Investigational Site 52147
RECRUITING
Oradea
Teva Investigational Site 52145
RECRUITING
Timișoara
Serbia
Teva Investigational Site 61088
RECRUITING
Belgrade
Teva Investigational Site 61089
RECRUITING
Belgrade
Teva Investigational Site 61090
RECRUITING
Belgrade
Teva Investigational Site 61092
RECRUITING
Belgrade
Teva Investigational Site 61093
RECRUITING
Belgrade
Teva Investigational Site 61094
RECRUITING
Kragujevac
Teva Investigational Site 61096
RECRUITING
Niš
Teva Investigational Site 61095
RECRUITING
Novi Sad
Teva Investigational Site 61091
RECRUITING
Užice
Slovakia
Teva Investigational Site 62102
RECRUITING
Košice
Teva Investigational Site 62103
COMPLETED
Martin
Teva Investigational Site 62101
RECRUITING
Spišská Nová Ves
South Africa
Teva Investigational Site 90099
RECRUITING
Bellville
Turkey
Teva Investigational Site 82089
RECRUITING
Adana
Teva Investigational Site 82085
RECRUITING
Kirikkale
Teva Investigational Site 82088
RECRUITING
Kocaeli
Teva Investigational Site 82087
RECRUITING
Mersin
Contact Information
Primary
Teva U.S. Medical Information
USMedInfo@tevapharm.com
1-888-483-8279
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2026-09-19
Participants
Target number of participants: 724
Treatments
Experimental: Fp/ABS eMDPI
Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module
Active_comparator: Fp eMDPI
Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)
Active_comparator: ABS eMDPI
Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)
Placebo_comparator: Placebo eMDPI
Related Therapeutic Areas
Sponsors
Leads: Teva Branded Pharmaceutical Products R&D LLC

This content was sourced from clinicaltrials.gov

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