Actively Recruiting
4-Week Double-Blind Trial of Fluticasone Propionate/Albuterol Sulfate Inhalers Compared to Individual Components or Placebo in Asthma Participants 12 Years and Older
Led by Teva Branded Pharmaceutical Products R&D LLC · Updated on 2026-06-08
724
Participants Needed
175
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered via a multidose dry powder inhaler with an electronic module in people aged 12 years and older who have asthma. The study is designed as a randomized, double-blind, placebo-controlled trial and aims to assess lung function improvements, safety, tolerability, and drug behavior in the body over a four-week period. Secondary goals include evaluating the combination inhaler administered four times daily and understanding the pharmacokinetics of the inhaler components after a single dose. Participants will be randomly assigned to one of four groups receiving either the combination inhaler (Fp/ABS), fluticasone propionate inhaler (Fp), albuterol sulfate inhaler (ABS), or a placebo inhaler, all with integrated electronic modules. Treatments are inhalation powders administered via dry powder inhalers. The study lasts about 10 weeks per participant, including the treatment period of four weeks and follow-up assessments. The trial includes a prescreening visit as an option before formal enrollment. During the study, participants will have their lung function measured through forced expiratory volume in one second (FEV1), asthma control assessed by questionnaires (ACQ-6 and ACT), and blood samples taken to analyze drug levels. Safety is monitored by tracking adverse events and tolerability over the treatment period. The main outcomes focus on changes in lung function at baseline and after four weeks of treatment. Participants are expected to attend multiple visits for these assessments throughout the study duration.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of asthma for at least 6 months
- Currently use a beta-agonist as rescue medication, with or without asthma controller medication
- Female participants must not be pregnant, breastfeeding, or trying to become pregnant for at least 30 days before screening and during the trial, or be of non-childbearing potential
- Aged 12 years or older
You will not qualify if you...
- History of life-threatening asthma requiring intubation or associated with severe complications
- Recent upper or lower respiratory tract infection within 2 weeks or confirmed COVID-19 within 6 weeks before screening
- Current smoker or history of 10 or more pack years of smoking
- Diagnosis of other lung disorders like COPD, chronic bronchitis, emphysema, bronchiectasis requiring treatment, cystic fibrosis, pulmonary fibrosis, or asthma COPD overlap syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive one of the inhalation powder treatments or placebo to manage asthma symptoms.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 175 locations
1
Teva Investigational Site 12087
Phoenix, Arizona, United States, 85015
Actively Recruiting
2
Teva Investigational Site 12144
Phoenix, Arizona, United States, 85020
Completed
3
Teva Investigational Site 12104
Tucson, Arizona, United States, 85715
Completed
4
Teva Investigational Site 12146
Tucson, Arizona, United States, 85741
Actively Recruiting
5
Teva Investigational Site 12102
Little Rock, Arkansas, United States, 72205
Actively Recruiting
6
Teva Investigational Site 12154
Encinitas, California, United States, 92024-2812
Actively Recruiting
7
Teva Investigational Site 12103
Huntington Beach, California, United States, 92647
Actively Recruiting
8
Teva Investigational Site 12068
La Palma, California, United States, 90623
Actively Recruiting
9
Teva Investigational Site 12152
Laguna Niguel, California, United States, 92677
Actively Recruiting
10
Teva Investigational Site 12145
Long Beach, California, United States, 90815
Actively Recruiting
11
Teva Investigational Site 12088
Los Angeles, California, United States, 90048
Actively Recruiting
12
Teva Investigational Site 12094
Los Angeles, California, United States, 93551
Actively Recruiting
13
Teva Investigational Site 12161
Northridge, California, United States, 91324
Actively Recruiting
14
Teva Investigational Site 12105
Oxnard, California, United States, 93030-5822
Actively Recruiting
15
Teva Investigational Site 12101
Sacramento, California, United States, 95821
Actively Recruiting
16
Teva Investigational Site 12064
San Jose, California, United States, 95117
Actively Recruiting
17
Teva Investigational Site 12109
Upland, California, United States, 91786
Completed
18
Teva Investigational Site 12070
Vista, California, United States, 92083
Completed
19
Teva Investigational Site 12091
Walnut Creek, California, United States, 94598
Actively Recruiting
20
Teva Investigational Site 12142
Lakewood, Colorado, United States, 80228
Actively Recruiting
21
Teva Investigational Site 12098
Lake City, Florida, United States, 32055-4880
Completed
22
Teva Investigational Site 12118
Lake Worth, Florida, United States, 33460-4400
Completed
23
Teva Investigational Site 12079
Melbourne, Florida, United States, 32934
Actively Recruiting
24
Teva Investigational Site 12071
Miami, Florida, United States, 33126
Actively Recruiting
25
Teva Investigational Site 12074
Miami, Florida, United States, 33135
Actively Recruiting
26
Teva Investigational Site 12086
Miami, Florida, United States, 33173
Actively Recruiting
27
Teva Investigational Site 12061
Miami, Florida, United States, 33174
Completed
28
Teva Investigational Site 12097
Miami, Florida, United States, 33175
Actively Recruiting
29
Teva Investigational Site 12092
Miami Lakes, Florida, United States, 33014
Completed
30
Teva Investigational Site 12076
North Miami Beach, Florida, United States, 33169
Completed
31
Teva Investigational Site 12095
Palmetto Bay, Florida, United States, 33157
Actively Recruiting
32
Teva Investigational Site 12075
Pompano Beach, Florida, United States, 33064
Actively Recruiting
33
Teva Investigational Site 12078
Tampa, Florida, United States, 33607
Actively Recruiting
34
Teva Investigational Site 12175
Conyers, Georgia, United States, 30012
Actively Recruiting
35
Teva Investigational Site 12156
Boise, Idaho, United States, 83706
Actively Recruiting
36
Teva Investigational Site 12162
Westchester, Illinois, United States, 60154
Actively Recruiting
37
Teva Investigational Site 12169
Shreveport, Louisiana, United States, 71105
Actively Recruiting
38
Teva Investigational Site 12081
Nottingham, Maryland, United States, 21236
Completed
39
Teva Investigational Site 12106
Towson, Maryland, United States, 21204
Actively Recruiting
40
Teva Investigational Site 12157
White Marsh, Maryland, United States, 21162-5503
Actively Recruiting
41
Teva Investigational Site 12119
Boston, Massachusetts, United States, 02115
Actively Recruiting
42
Teva Investigational Site 12073
Minneapolis, Minnesota, United States, 55402-2606
Completed
43
Teva Investigational Site 12066
Richfield, Minnesota, United States, 55423
Actively Recruiting
44
Teva Investigational Site 12149
Columbia, Missouri, United States, 65203
Actively Recruiting
45
Teva Investigational Site 12108
St Louis, Missouri, United States, 63110
Actively Recruiting
46
Teva Investigational Site 12089
St Louis, Missouri, United States, 63141
Actively Recruiting
47
Teva Investigational Site 12158
Hastings, Nebraska, United States, 68901
Actively Recruiting
48
Teva Investigational Site 12160
Las Vegas, Nevada, United States, 89113
Actively Recruiting
49
Teva Investigational Site 12150
Las Vegas, Nevada, United States, 89119
Actively Recruiting
50
Teva Investigational Site 12110
Jersey City, New Jersey, United States, 07306
Actively Recruiting
51
Teva Investigational Site 12167
Buffalo, New York, United States, 14203
Actively Recruiting
52
Teva Investigational Site 12115
Charlotte, North Carolina, United States, 28207
Actively Recruiting
53
Teva Investigational Site 12085
Raleigh, North Carolina, United States, 27607-6689
Actively Recruiting
54
Teva Investigational Site 12063
Toledo, Ohio, United States, 43617
Actively Recruiting
55
Teva Investigational Site 12178
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
56
Teva Investigational Site 12155
Tulsa, Oklahoma, United States, 74133
Actively Recruiting
57
Teva Investigational Site 12170
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
58
Teva Investigational Site 12117
Clackamas, Oregon, United States, 97015
Completed
59
Teva Investigational Site 12151
Portland, Oregon, United States, 97202
Actively Recruiting
60
Teva Investigational Site 12147
Horsham, Pennsylvania, United States, 19044
Completed
61
Teva Investigational Site 12072
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
62
Teva Investigational Site 12114
Pittsburgh, Pennsylvania, United States, 15241
Actively Recruiting
63
Teva Investigational Site 12067
Columbia, South Carolina, United States, 29204
Completed
64
Teva Investigational Site 12111
Myrtle Beach, South Carolina, United States, 29572
Completed
65
Teva Investigational Site 12112
North Charleston, South Carolina, United States, 29420
Completed
66
Teva Investigational Site 12107
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
67
Teva Investigational Site 12083
Austin, Texas, United States, 78744
Actively Recruiting
68
Teva Investigational Site 12060
Austin, Texas, United States, 78759
Actively Recruiting
69
Teva Investigational Site 12077
Corsicana, Texas, United States, 75110-2471
Completed
70
Teva Investigational Site 12159
Dallas, Texas, United States, 75225-6301
Actively Recruiting
71
Teva Investigational Site 12171
Dallas, Texas, United States, 75235
Actively Recruiting
72
Teva Investigational Site 12090
Dallas, Texas, United States, 75243
Actively Recruiting
73
Teva Investigational Site 12143
El Paso, Texas, United States, 79912
Actively Recruiting
74
Teva Investigational Site 12168
Houston, Texas, United States, 77018
Actively Recruiting
75
Teva Investigational Site 12176
Kerrville, Texas, United States, 78028
Actively Recruiting
76
Teva Investigational Site 12080
Kingwood, Texas, United States, 77339
Completed
77
Teva Investigational Site 12096
McKinney, Texas, United States, 75069
Actively Recruiting
78
Teva Investigational Site 12113
Mesquite, Texas, United States, 75150
Actively Recruiting
79
Teva Investigational Site 12166
Sugar Land, Texas, United States, 77479
Actively Recruiting
80
Teva Investigational Site 12084
Victoria, Texas, United States, 77901
Actively Recruiting
81
Teva Investigational Site 12148
Pleasant View, Utah, United States, 84404-4791
Actively Recruiting
82
Teva Investigational Site 12082
Salt Lake City, Utah, United States, 84123
Completed
83
Teva Investigational Site 12153
South Ogden, Utah, United States, 84405
Actively Recruiting
84
Teva Investigational Site 12093
Portsmouth, Virginia, United States, 23703
Completed
85
Teva Investigational Site 12062
Greenfield, Wisconsin, United States, 53228
Actively Recruiting
86
Teva Investigational Site 20154
Buenos Aires, Argentina, C1426ABP
Actively Recruiting
87
Teva Investigational Site 20156
Buenos Aires, Argentina, S2013DTC
Actively Recruiting
88
Teva Investigational Site 20157
Córdoba, Argentina, X5003DCE
Actively Recruiting
89
Teva Investigational Site 20150
Córdoba, Argentina, X5014AKM
Actively Recruiting
90
Teva Investigational Site 20160
Florida, Vicente Lopez, Argentina, B1602DQD
Actively Recruiting
91
Teva Investigational Site 20145
Mar del Plata, Argentina, 7600
Actively Recruiting
92
Teva Investigational Site 20151
Mar del Plata, Argentina, B7612ENA
Actively Recruiting
93
Teva Investigational Site 20161
Mendoza, Argentina, 5500
Actively Recruiting
94
Teva Investigational Site 20146
Quilmes, Argentina, 1878
Actively Recruiting
95
Teva Investigational Site 20148
Rosario, Argentina, 2013
Actively Recruiting
96
Teva Investigational Site 20155
Rosario, Argentina, S2000DEJ
Actively Recruiting
97
Teva Investigational Site 20147
San Juan Bautista, Argentina, B1853AIK
Actively Recruiting
98
Teva Investigational Site 20152
San Miguel de Tucumán, Argentina, 4000
Actively Recruiting
99
Teva Investigational Site 20159
San Miguel de Tucumán, Argentina, 4000
Actively Recruiting
100
Teva Investigational Site 20149
San Miguel de Tucumán, Argentina, T4000IFL
Actively Recruiting
101
Teva Investigational Site 20158
Santa Fe, Argentina, S3000ASF
Actively Recruiting
102
Teva Investigational Site 59248
Haskovo, Bulgaria, 6305
Actively Recruiting
103
Teva Investigational Site 59251
Lovech, Bulgaria, 5500
Actively Recruiting
104
Teva Investigational Site 59249
Montana, Bulgaria, 3400
Actively Recruiting
105
Teva Investigational Site 59258
Montana, Bulgaria, 3400
Actively Recruiting
106
Teva Investigational Site 59247
Pleven, Bulgaria, 5800
Actively Recruiting
107
Teva Investigational Site 59259
Rousse, Bulgaria, 7002
Actively Recruiting
108
Teva Investigational Site 59256
Sliven, Bulgaria, 8800
Actively Recruiting
109
Teva Investigational Site 59246
Sofia, Bulgaria, 1142
Actively Recruiting
110
Teva Investigational Site 59252
Sofia, Bulgaria, 1233
Actively Recruiting
111
Teva Investigational Site 59257
Sofia, Bulgaria, 1421
Actively Recruiting
112
Teva Investigational Site 59253
Sofia, Bulgaria, 5400
Completed
113
Teva Investigational Site 59245
Stara Zagora, Bulgaria, 6000
Actively Recruiting
114
Teva Investigational Site 59254
Veliko Tarnovo, Bulgaria, 5000
Actively Recruiting
115
Teva Investigational Site 59250
Vratsa, Bulgaria, 3000
Actively Recruiting
116
Teva Investigational Site 54248
Brno, Czechia, 618 00
Actively Recruiting
117
Teva Investigational Site 54245
Jindřichův Hradec, Czechia, 37738
Actively Recruiting
118
Teva Investigational Site 54246
Prague, Czechia, 148 00
Actively Recruiting
119
Teva Investigational Site 54249
Prague, Czechia, 190 00
Actively Recruiting
120
Teva Investigational Site 54244
Teplice, Czechia, 41501
Actively Recruiting
121
Teva Investigational Site 54243
Varnsdorf, Czechia, 40747
Actively Recruiting
122
Teva Investigational Site 32881
Ahrensburg, Germany, 22926
Actively Recruiting
123
Teva Investigational Site 32880
Bendorf, Germany, 56170
Actively Recruiting
124
Teva Investigational Site 32884
Berlin, Germany, 10717
Actively Recruiting
125
Teva Investigational Site 32886
Berlin, Germany, 10787
Actively Recruiting
126
Teva Investigational Site 32893
Delitzsch, Germany, 04509
Actively Recruiting
127
Teva Investigational Site 32879
Frankfurt, Germany, 60596
Actively Recruiting
128
Teva Investigational Site 32892
Frankfurt, Germany, 60596
Actively Recruiting
129
Teva Investigational Site 32887
Leipzig, Germany, 04177
Actively Recruiting
130
Teva Investigational Site 32876
Leipzig, Germany, 04207
Actively Recruiting
131
Teva Investigational Site 32883
Leipzig - Nordost, Germany, 04347
Completed
132
Teva Investigational Site 32877
Magdeburg, Germany, 39120
Actively Recruiting
133
Teva Investigational Site 32878
Mainz A. Rhein, Germany, 55128
Actively Recruiting
134
Teva Investigational Site 32888
Neu-Isenburg, Germany, 63263
Actively Recruiting
135
Teva Investigational Site 32890
Peine, Germany, 31224
Actively Recruiting
136
Teva Investigational Site 32882
Rheine, Germany, 48431
Actively Recruiting
137
Teva Investigational Site 32889
Witten, Germany, 58452
Actively Recruiting
138
Teva Investigational Site 80207
Be’er Ya‘aqov, Israel, 70300
Completed
139
Teva Investigational Site 80206
Haifa, Israel, 3109601
Actively Recruiting
140
Teva Investigational Site 80208
Jerusalem, Israel, 91240
Actively Recruiting
141
Teva Investigational Site 21133
Chihuahua City, Mexico, 31203
Actively Recruiting
142
Teva Investigational Site 21134
Mexico City, Mexico, 14090
Actively Recruiting
143
Teva Investigational Site 21137
Morelia, Mexico, 58260
Actively Recruiting
144
Teva Investigational Site 21136
Tlalnepantla, Mexico, 54055
Actively Recruiting
145
Teva Investigational Site 21135
Zapopan, Mexico, 45138
Actively Recruiting
146
Teva Investigational Site 53582
Bialystok, Poland, 15-010
Actively Recruiting
147
Teva Investigational Site 53580
Bialystok, Poland, 15-430
Actively Recruiting
148
Teva Investigational Site 53578
Gdansk, Poland, 84-230
Completed
149
Teva Investigational Site 53575
Lodz, Poland, 90-127
Actively Recruiting
150
Teva Investigational Site 53576
Lodz, Poland, 95-002
Completed
151
Teva Investigational Site 53581
Maków Podhalański, Poland, 34-220
Actively Recruiting
152
Teva Investigational Site 53579
Poznan, Poland, 60-309
Actively Recruiting
153
Teva Investigational Site 53574
Tarnów, Poland, 70-332
Actively Recruiting
154
Teva Investigational Site 53577
Wroclaw, Poland, 50-381
Actively Recruiting
155
Teva Investigational Site 52149
Bucharest, Romania, 077025
Actively Recruiting
156
Teva Investigational Site 52148
Craiova, Romania, 410169
Actively Recruiting
157
Teva Investigational Site 52147
Oradea, Romania, 410169
Actively Recruiting
158
Teva Investigational Site 52145
Timișoara, Romania, 2447
Actively Recruiting
159
Teva Investigational Site 61089
Belgrade, Serbia, 11000
Actively Recruiting
160
Teva Investigational Site 61090
Belgrade, Serbia, 11000
Actively Recruiting
161
Teva Investigational Site 61093
Belgrade, Serbia, 11000
Actively Recruiting
162
Teva Investigational Site 61092
Belgrade, Serbia, 11070
Actively Recruiting
163
Teva Investigational Site 61088
Belgrade, Serbia, 11080
Actively Recruiting
164
Teva Investigational Site 61094
Kragujevac, Serbia, 34000
Actively Recruiting
165
Teva Investigational Site 61096
Niš, Serbia, 18 000
Actively Recruiting
166
Teva Investigational Site 61095
Novi Sad, Serbia, 21000
Actively Recruiting
167
Teva Investigational Site 61091
Užice, Serbia, 501715
Actively Recruiting
168
Teva Investigational Site 62102
Košice, Slovakia, 04022
Actively Recruiting
169
Teva Investigational Site 62103
Martin, Slovakia, 03601
Completed
170
Teva Investigational Site 62104
Slovakia, Slovakia, 06224
Actively Recruiting
171
Teva Investigational Site 62101
Spišská Nová Ves, Slovakia, 05201
Actively Recruiting
172
Teva Investigational Site 82089
Adana, Turkey (Türkiye), 1330
Actively Recruiting
173
Teva Investigational Site 82085
Kirikkale, Turkey (Türkiye), 71450
Actively Recruiting
174
Teva Investigational Site 82088
Kocaeli, Turkey (Türkiye), 41140
Actively Recruiting
175
Teva Investigational Site 82087
Mersin, Turkey (Türkiye), 33343
Actively Recruiting
Research Team
T
Teva U.S. Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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