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 (111) 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
RECRUITING
Phoenix
Teva Investigational Site 12104
RECRUITING
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 12145
RECRUITING
Long Beach
Teva Investigational Site 12088
RECRUITING
Los Angeles
Teva Investigational Site 12094
RECRUITING
Los Angeles
Teva Investigational Site 12105
RECRUITING
Oxnard
Teva Investigational Site 12101
RECRUITING
Sacramento
Teva Investigational Site 12064
RECRUITING
San Jose
Teva Investigational Site 12109
RECRUITING
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
RECRUITING
Lake City
Teva Investigational Site 12118
RECRUITING
Lake Worth
Teva Investigational Site 12079
RECRUITING
Melbourne
Teva Investigational Site 12061
RECRUITING
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
Idaho
Teva Investigational Site 12156
RECRUITING
Boise
Massachusetts
Teva Investigational Site 12119
RECRUITING
Boston
Maryland
Teva Investigational Site 12081
RECRUITING
Nottingham
Teva Investigational Site 12106
RECRUITING
Towson
Teva Investigational Site 12157
RECRUITING
White Marsh
Minnesota
Teva Investigational Site 12073
RECRUITING
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
New Jersey
Teva Investigational Site 12110
RECRUITING
Jersey City
Nevada
Teva Investigational Site 12150
RECRUITING
Las Vegas
Teva Investigational Site 12160
RECRUITING
Las Vegas
Ohio
Teva Investigational Site 12063
RECRUITING
Toledo
Oklahoma
Teva Investigational Site 12155
RECRUITING
Tulsa
Oregon
Teva Investigational Site 12117
RECRUITING
Clackamas
Teva Investigational Site 12151
RECRUITING
Portland
Pennsylvania
Teva Investigational Site 12147
RECRUITING
Horsham
Teva Investigational Site 12072
RECRUITING
Philadelphia
Teva Investigational Site 12114
RECRUITING
Pittsburgh
South Carolina
Teva Investigational Site 12067
RECRUITING
Columbia
Teva Investigational Site 12111
RECRUITING
Myrtle Beach
Teva Investigational Site 12112
RECRUITING
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
RECRUITING
Corsicana
Teva Investigational Site 12090
RECRUITING
Dallas
Teva Investigational Site 12143
RECRUITING
El Paso
Teva Investigational Site 12080
RECRUITING
Kingwood
Teva Investigational Site 12096
RECRUITING
Mckinney
Teva Investigational Site 12113
RECRUITING
Mesquite
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
RECRUITING
Portsmouth
Wisconsin
Teva Investigational Site 12062
RECRUITING
Greenfield
Other Locations
Argentina
Teva Investigational Site 20154
RECRUITING
Buenos Aires
Teva Investigational Site 20155
RECRUITING
Rosario
Teva Investigational Site 20149
RECRUITING
San Miguel De Tucumán
Teva Investigational Site 20152
RECRUITING
San Miguel De Tucumán
Bulgaria
Teva Investigational Site 59248
RECRUITING
Haskovo
Teva Investigational Site 59251
RECRUITING
Lovech
Teva Investigational Site 59249
RECRUITING
Montana
Teva Investigational Site 59247
RECRUITING
Pleven
Teva Investigational Site 59246
RECRUITING
Sofia
Teva Investigational Site 59252
RECRUITING
Sofia
Teva Investigational Site 59253
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 32879
RECRUITING
Frankfurt
Teva Investigational Site 32876
RECRUITING
Leipzig
Teva Investigational Site 32883
RECRUITING
Leipzig
Teva Investigational Site 32877
RECRUITING
Magdeburg
Teva Investigational Site 32878
RECRUITING
Mainz A. Rhein
Teva Investigational Site 32882
RECRUITING
Rheine
Israel
Teva Investigational Site 80207
RECRUITING
Be’er Ya‘aqov
Teva Investigational Site 80206
RECRUITING
Haifa
Teva Investigational Site 80208
RECRUITING
Jerusalem
Poland
Teva Investigational Site 53578
RECRUITING
Gdansk
Teva Investigational Site 53575
RECRUITING
Lodz
Teva Investigational Site 53576
RECRUITING
Lodz
Teva Investigational Site 53574
RECRUITING
Tarnów
Teva Investigational Site 53577
RECRUITING
Wroclaw
Romania
Teva Investigational Site 52147
RECRUITING
Oradea
Teva Investigational Site 52145
RECRUITING
Timișoara
Slovakia
Teva Investigational Site 62102
RECRUITING
Košice
Teva Investigational Site 62103
RECRUITING
Martin
Teva Investigational Site 62101
RECRUITING
Spišská Nová Ves
Turkey
Teva Investigational Site 82089
RECRUITING
Adana
Teva Investigational Site 82085
RECRUITING
Kırıkkale
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: 2026-05-31
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, Inc.

This content was sourced from clinicaltrials.gov

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