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
Start Date
12/12/2024
Completion Date
9/19/2026
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 Criteria
Age Range: 12 years to No maximum
Interventions
Fp/ABS
FP
ABS
Placebo
Conditions
Locations
Teva Investigational Site 12087
Phoenix, Arizona 85015
United States
Teva Investigational Site 12144
Phoenix, Arizona 85020
United States
Teva Investigational Site 12104
Tucson, Arizona 85715
United States
Teva Investigational Site 12146
Tucson, Arizona 85741
United States
Teva Investigational Site 12102
Little Rock, Arkansas 72205
United States
Teva Investigational Site 12154
Encinitas, California 92024-2812
United States
Teva Investigational Site 12103
Huntington Beach, California 92647
United States
Teva Investigational Site 12068
La Palma, California 90623
United States
Teva Investigational Site 12152
Laguna Niguel, California 92677
United States
Teva Investigational Site 12145
Long Beach, California 90815
United States
Teva Investigational Site 12088
Los Angeles, California 90048
United States
Teva Investigational Site 12094
Los Angeles, California 93551
United States
Teva Investigational Site 12161
Northridge, California 91324
United States
Teva Investigational Site 12105
Oxnard, California 93030-5822
United States
Teva Investigational Site 12101
Sacramento, California 95821
United States
Teva Investigational Site 12064
San Jose, California 95117
United States
Teva Investigational Site 12109
Upland, California 91786
United States
Teva Investigational Site 12070
Vista, California 92083
United States
Teva Investigational Site 12091
Walnut Creek, California 94598
United States
Teva Investigational Site 12142
Lakewood, Colorado 80228
United States
Teva Investigational Site 12098
Lake City, Florida 32055-4880
United States
Teva Investigational Site 12118
Lake Worth, Florida 33460-4400
United States
Teva Investigational Site 12079
Melbourne, Florida 32934
United States
Teva Investigational Site 12071
Miami, Florida 33126
United States
Teva Investigational Site 12074
Miami, Florida 33135
United States
Teva Investigational Site 12086
Miami, Florida 33173
United States
Teva Investigational Site 12061
Miami, Florida 33174
United States
Teva Investigational Site 12097
Miami, Florida 33175
United States
Teva Investigational Site 12092
Miami Lakes, Florida 33014
United States
Teva Investigational Site 12076
North Miami Beach, Florida 33169
United States
Teva Investigational Site 12095
Palmetto Bay, Florida 33157
United States
Teva Investigational Site 12075
Pompano Beach, Florida 33064
United States
Teva Investigational Site 12078
Tampa, Florida 33607
United States
Teva Investigational Site 12175
Conyers, Georgia 30012
United States
Teva Investigational Site 12156
Boise, Idaho 83706
United States
Teva Investigational Site 12162
Westchester, Illinois 60154
United States
Teva Investigational Site 12169
Shreveport, Louisiana 71105
United States
Teva Investigational Site 12081
Nottingham, Maryland 21236
United States
Teva Investigational Site 12106
Towson, Maryland 21204
United States
Teva Investigational Site 12157
White Marsh, Maryland 21162-5503
United States
Teva Investigational Site 12119
Boston, Massachusetts 02115
United States
Teva Investigational Site 12182
South Dartmouth, Massachusetts 02747
United States
Teva Investigational Site 12073
Minneapolis, Minnesota 55402-2606
United States
Teva Investigational Site 12066
Richfield, Minnesota 55423
United States
Teva Investigational Site 12149
Columbia, Missouri 65203
United States
Teva Investigational Site 12108
St Louis, Missouri 63110
United States
Teva Investigational Site 12089
St Louis, Missouri 63141
United States
Teva Investigational Site 12158
Hastings, Nebraska 68901
United States
Teva Investigational Site 12160
Las Vegas, Nevada 89113
United States
Teva Investigational Site 12150
Las Vegas, Nevada 89119
United States
Teva Investigational Site 12110
Jersey City, New Jersey 07306
United States
Teva Investigational Site 12167
Buffalo, New York 14203
United States
Teva Investigational Site 12115
Charlotte, North Carolina 28207
United States
Teva Investigational Site 12085
Raleigh, North Carolina 27607-6689
United States
Teva Investigational Site 12063
Toledo, Ohio 43617
United States
Teva Investigational Site 12178
Oklahoma City, Oklahoma 73120
United States
Teva Investigational Site 12155
Tulsa, Oklahoma 74133
United States
Teva Investigational Site 12170
Tulsa, Oklahoma 74136
United States
Teva Investigational Site 12117
Clackamas, Oregon 97015
United States
Teva Investigational Site 12151
Portland, Oregon 97202
United States
Teva Investigational Site 12147
Horsham, Pennsylvania 19044
United States
Teva Investigational Site 12072
Philadelphia, Pennsylvania 19107
United States
Teva Investigational Site 12114
Pittsburgh, Pennsylvania 15241
United States
Teva Investigational Site 12067
Columbia, South Carolina 29204
United States
Teva Investigational Site 12111
Myrtle Beach, South Carolina 29572
United States
Teva Investigational Site 12112
North Charleston, South Carolina 29420
United States
Teva Investigational Site 12107
Rock Hill, South Carolina 29732
United States
Teva Investigational Site 12083
Austin, Texas 78744
United States
Teva Investigational Site 12060
Austin, Texas 78759
United States
Teva Investigational Site 12077
Corsicana, Texas 75110-2471
United States
Teva Investigational Site 12179
Cypress, Texas 77429
United States
Teva Investigational Site 12159
Dallas, Texas 75225-6301
United States
Teva Investigational Site 12171
Dallas, Texas 75235
United States
Teva Investigational Site 12090
Dallas, Texas 75243
United States
Teva Investigational Site 12143
El Paso, Texas 79912
United States
Teva Investigational Site 12181
Houston, Texas 77008-1528
United States
Teva Investigational Site 12168
Houston, Texas 77018
United States
Teva Investigational Site 12176
Kerrville, Texas 78028
United States
Teva Investigational Site 12080
Kingwood, Texas 77339
United States
Teva Investigational Site 12096
McKinney, Texas 75069
United States
Teva Investigational Site 12113
Mesquite, Texas 75150
United States
Teva Investigational Site 12166
Sugar Land, Texas 77479
United States
Teva Investigational Site 12084
Victoria, Texas 77901
United States
Teva Investigational Site 12148
Pleasant View, Utah 84404-4791
United States
Teva Investigational Site 12082
Salt Lake City, Utah 84123
United States
Teva Investigational Site 12153
South Ogden, Utah 84405
United States
Teva Investigational Site 12093
Portsmouth, Virginia 23703
United States
Teva Investigational Site 12062
Greenfield, Wisconsin 53228
United States
Teva Investigational Site 20154
Buenos Aires, C1426ABP
Argentina
Teva Investigational Site 20156
Buenos Aires, S2013DTC
Argentina
Teva Investigational Site 20157
Córdoba, X5003DCE
Argentina
Teva Investigational Site 20150
Córdoba, X5014AKM
Argentina
Teva Investigational Site 20160
Florida, B1602DQD
Argentina
Teva Investigational Site 20145
Mar del Plata, 7600
Argentina
Teva Investigational Site 20151
Mar del Plata, B7612ENA
Argentina
Teva Investigational Site 20161
Mendoza, 5500
Argentina
Teva Investigational Site 20146
Quilmes, 1878
Argentina
Teva Investigational Site 20148
Rosario, 2013
Argentina
Teva Investigational Site 20155
Rosario, S2000DEJ
Argentina
Teva Investigational Site 20147
San Juan Bautista, B1853AIK
Argentina
Teva Investigational Site 20152
San Miguel de Tucumán, 4000
Argentina
Teva Investigational Site 20159
San Miguel de Tucumán, 4000
Argentina
Teva Investigational Site 20149
San Miguel de Tucumán, T4000IFL
Argentina
Teva Investigational Site 20158
Santa Fe, S3000ASF
Argentina
Teva Investigational Site 59248
Haskovo, 6305
Bulgaria
Teva Investigational Site 59251
Lovech, 5500
Bulgaria
Teva Investigational Site 59249
Montana, 3400
Bulgaria
Teva Investigational Site 59258
Montana, 3400
Bulgaria
Teva Investigational Site 59247
Pleven, 5800
Bulgaria
Teva Investigational Site 59259
Rousse, 7002
Bulgaria
Teva Investigational Site 59256
Sliven, 8800
Bulgaria
Teva Investigational Site 59246
Sofia, 1142
Bulgaria
Teva Investigational Site 59252
Sofia, 1233
Bulgaria
Teva Investigational Site 59257
Sofia, 1421
Bulgaria
Teva Investigational Site 59253
Sofia, 5400
Bulgaria
Teva Investigational Site 59245
Stara Zagora, 6000
Bulgaria
Teva Investigational Site 59254
Veliko Tarnovo, 5000
Bulgaria
Teva Investigational Site 59250
Vratsa, 3000
Bulgaria
Teva Investigational Site 54247
Brandýs nad Labem, 25001
Czechia
Teva Investigational Site 54248
Brno, 618 00
Czechia
Teva Investigational Site 54245
Jindřichův Hradec, 37738
Czechia
Teva Investigational Site 54246
Prague, 148 00
Czechia
Teva Investigational Site 54249
Prague, 190 00
Czechia
Teva Investigational Site 54244
Teplice, 41501
Czechia
Teva Investigational Site 54243
Varnsdorf, 40747
Czechia
Teva Investigational Site 32881
Ahrensburg, 22926
Germany
Teva Investigational Site 32880
Bendorf, 56170
Germany
Teva Investigational Site 32884
Berlin, 10717
Germany
Teva Investigational Site 32886
Berlin, 10787
Germany
Teva Investigational Site 32893
Delitzsch, 04509
Germany
Teva Investigational Site 32879
Frankfurt, 60596
Germany
Teva Investigational Site 32892
Frankfurt, 60596
Germany
Teva Investigational Site 32887
Leipzig, 04177
Germany
Teva Investigational Site 32876
Leipzig, 04207
Germany
Teva Investigational Site 32883
Leipzig, 04347
Germany
Teva Investigational Site 32877
Magdeburg, 39120
Germany
Teva Investigational Site 32878
Mainz, 55128
Germany
Teva Investigational Site 32888
Neu-Isenburg, 63263
Germany
Teva Investigational Site 32890
Peine, 31224
Germany
Teva Investigational Site 32882
Rheine, 48431
Germany
Teva Investigational Site 32889
Witten, 58452
Germany
Teva Investigational Site 80207
Be'er Yaakov, 70300
Israel
Teva Investigational Site 80206
Haifa, 3109601
Israel
Teva Investigational Site 80208
Jerusalem, 91240
Israel
Teva Investigational Site 21133
Chihuahua City, 31203
Mexico
Teva Investigational Site 21134
Mexico City, 14090
Mexico
Teva Investigational Site 21137
Morelia, 58260
Mexico
Teva Investigational Site 21136
Tlalnepantla, 54055
Mexico
Teva Investigational Site 21135
Zapopan, 45138
Mexico
Teva Investigational Site 53582
Bialystok, 15-010
Poland
Teva Investigational Site 53580
Bialystok, 15-430
Poland
Teva Investigational Site 53578
Gdansk, 84-230
Poland
Teva Investigational Site 53575
Lodz, 90-127
Poland
Teva Investigational Site 53576
Lodz, 95-002
Poland
Teva Investigational Site 53581
Maków Podhalański, 34-220
Poland
Teva Investigational Site 53579
Poznan, 60-309
Poland
Teva Investigational Site 53574
Tarnów, 70-332
Poland
Teva Investigational Site 53577
Wroclaw, 50-381
Poland
Teva Investigational Site 52149
Bucharest, 077025
Romania
Teva Investigational Site 52148
Craiova, 410169
Romania
Teva Investigational Site 52147
Oradea, 410169
Romania
Teva Investigational Site 52145
Timișoara, 2447
Romania
Teva Investigational Site 61089
Belgrade, 11000
Serbia
Teva Investigational Site 61090
Belgrade, 11000
Serbia
Teva Investigational Site 61093
Belgrade, 11000
Serbia
Teva Investigational Site 61092
Belgrade, 11070
Serbia
Teva Investigational Site 61088
Belgrade, 11080
Serbia
Teva Investigational Site 61094
Kragujevac, 34000
Serbia
Teva Investigational Site 61096
Niš, 18 000
Serbia
Teva Investigational Site 61095
Novi Sad, 21000
Serbia
Teva Investigational Site 61091
Užice, 501715
Serbia
Teva Investigational Site 62102
Košice, 04022
Slovakia
Teva Investigational Site 62103
Martin, 03601
Slovakia
Teva Investigational Site 62101
Spišská Nová Ves, 05201
Slovakia
Teva Investigational Site 90099
Bellville, 7530
South Africa
Teva Investigational Site 90096
Pietermaritzburg, 944
South Africa
Teva Investigational Site 90098
Pretoria, 0157
South Africa
Teva Investigational Site 90105
Pretoria, 204
South Africa
Teva Investigational Site 90097
Vhembe, 1685
South Africa
Teva Investigational Site 82089
Adana, 1330
Turkey (Türkiye)
Teva Investigational Site 82085
Kirikkale, 71450
Turkey (Türkiye)
Teva Investigational Site 82088
Kocaeli, 41140
Turkey (Türkiye)
Teva Investigational Site 82087
Mersin, 33343
Turkey (Türkiye)