Actively Recruiting

Phase 3
Age: 12Years +
All Genders
NCT06664619

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

Led by Teva Branded Pharmaceutical Products R&D LLC · Updated on 2026-05-12

724

Participants Needed

163

Research Sites

76 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of asthma for at least 6 months
  • Currently using a beta-agonist (e.g., albuterol) as rescue medication with or without asthma controller medication
  • If female, not pregnant, breastfeeding, or attempting to become pregnant for at least 30 days before screening and during the trial, or is of non-childbearing potential
Not Eligible

You will not qualify if you...

  • History of life-threatening asthma requiring intubation or associated with severe complications
  • Upper or lower respiratory tract infection within 2 weeks before screening or confirmed COVID-19 within 6 weeks before screening
  • Current smoker or history of 10 or more pack years of smoking, including use of any tobacco or inhaled products in past 6 months
  • Diagnosis of other lung disorders such as COPD, chronic bronchitis, emphysema, bronchiectasis needing 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

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Trial Site Locations

Total: 163 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 12155

Tulsa, Oklahoma, United States, 74133

Actively Recruiting

56

Teva Investigational Site 12170

Tulsa, Oklahoma, United States, 74136

Actively Recruiting

57

Teva Investigational Site 12117

Clackamas, Oregon, United States, 97015

Completed

58

Teva Investigational Site 12151

Portland, Oregon, United States, 97202

Actively Recruiting

59

Teva Investigational Site 12147

Horsham, Pennsylvania, United States, 19044

Completed

60

Teva Investigational Site 12072

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

61

Teva Investigational Site 12114

Pittsburgh, Pennsylvania, United States, 15241

Actively Recruiting

62

Teva Investigational Site 12067

Columbia, South Carolina, United States, 29204

Completed

63

Teva Investigational Site 12111

Myrtle Beach, South Carolina, United States, 29572

Completed

64

Teva Investigational Site 12112

North Charleston, South Carolina, United States, 29420

Completed

65

Teva Investigational Site 12107

Rock Hill, South Carolina, United States, 29732

Actively Recruiting

66

Teva Investigational Site 12083

Austin, Texas, United States, 78744

Actively Recruiting

67

Teva Investigational Site 12060

Austin, Texas, United States, 78759

Actively Recruiting

68

Teva Investigational Site 12077

Corsicana, Texas, United States, 75110-2471

Completed

69

Teva Investigational Site 12159

Dallas, Texas, United States, 75225-6301

Actively Recruiting

70

Teva Investigational Site 12171

Dallas, Texas, United States, 75235

Actively Recruiting

71

Teva Investigational Site 12090

Dallas, Texas, United States, 75243

Actively Recruiting

72

Teva Investigational Site 12143

El Paso, Texas, United States, 79912

Actively Recruiting

73

Teva Investigational Site 12168

Houston, Texas, United States, 77018

Actively Recruiting

74

Teva Investigational Site 12176

Kerrville, Texas, United States, 78028

Actively Recruiting

75

Teva Investigational Site 12080

Kingwood, Texas, United States, 77339

Completed

76

Teva Investigational Site 12096

McKinney, Texas, United States, 75069

Actively Recruiting

77

Teva Investigational Site 12113

Mesquite, Texas, United States, 75150

Actively Recruiting

78

Teva Investigational Site 12166

Sugar Land, Texas, United States, 77479

Actively Recruiting

79

Teva Investigational Site 12084

Victoria, Texas, United States, 77901

Actively Recruiting

80

Teva Investigational Site 12148

Pleasant View, Utah, United States, 84404-4791

Actively Recruiting

81

Teva Investigational Site 12082

Salt Lake City, Utah, United States, 84123

Completed

82

Teva Investigational Site 12153

South Ogden, Utah, United States, 84405

Actively Recruiting

83

Teva Investigational Site 12093

Portsmouth, Virginia, United States, 23703

Completed

84

Teva Investigational Site 12062

Greenfield, Wisconsin, United States, 53228

Actively Recruiting

85

Teva Investigational Site 20154

Buenos Aires, Argentina, C1426ABP

Actively Recruiting

86

Teva Investigational Site 20156

Buenos Aires, Argentina, S2013DTC

Actively Recruiting

87

Teva Investigational Site 20157

Córdoba, Argentina, X5003DCE

Actively Recruiting

88

Teva Investigational Site 20150

Córdoba, Argentina, X5014AKM

Actively Recruiting

89

Teva Investigational Site 20145

Mar del Plata, Argentina, 7600

Actively Recruiting

90

Teva Investigational Site 20151

Mar del Plata, Argentina, B7612ENA

Actively Recruiting

91

Teva Investigational Site 20161

Mendoza, Argentina, 5500

Actively Recruiting

92

Teva Investigational Site 20146

Quilmes, Argentina, 1878

Actively Recruiting

93

Teva Investigational Site 20148

Rosario, Argentina, 2013

Actively Recruiting

94

Teva Investigational Site 20155

Rosario, Argentina, S2000DEJ

Actively Recruiting

95

Teva Investigational Site 20147

San Juan Bautista, Argentina, B1853AIK

Actively Recruiting

96

Teva Investigational Site 20152

San Miguel de Tucumán, Argentina, 4000

Actively Recruiting

97

Teva Investigational Site 20149

San Miguel de Tucumán, Argentina, T4000IFL

Actively Recruiting

98

Teva Investigational Site 59248

Haskovo, Bulgaria, 6305

Actively Recruiting

99

Teva Investigational Site 59251

Lovech, Bulgaria, 5500

Actively Recruiting

100

Teva Investigational Site 59249

Montana, Bulgaria, 3400

Actively Recruiting

101

Teva Investigational Site 59247

Pleven, Bulgaria, 5800

Completed

102

Teva Investigational Site 59256

Sliven, Bulgaria, 8800

Actively Recruiting

103

Teva Investigational Site 59246

Sofia, Bulgaria, 1142

Actively Recruiting

104

Teva Investigational Site 59252

Sofia, Bulgaria, 1233

Actively Recruiting

105

Teva Investigational Site 59257

Sofia, Bulgaria, 1421

Actively Recruiting

106

Teva Investigational Site 59253

Sofia, Bulgaria, 5400

Completed

107

Teva Investigational Site 59245

Stara Zagora, Bulgaria, 6000

Actively Recruiting

108

Teva Investigational Site 59254

Veliko Tarnovo, Bulgaria, 5000

Actively Recruiting

109

Teva Investigational Site 59250

Vratsa, Bulgaria, 3000

Actively Recruiting

110

Teva Investigational Site 54245

Jindřichův Hradec, Czechia, 37738

Actively Recruiting

111

Teva Investigational Site 54244

Teplice, Czechia, 41501

Actively Recruiting

112

Teva Investigational Site 54243

Varnsdorf, Czechia, 40747

Actively Recruiting

113

Teva Investigational Site 32881

Ahrensburg, Germany, 22926

Actively Recruiting

114

Teva Investigational Site 32880

Bendorf, Germany, 56170

Actively Recruiting

115

Teva Investigational Site 32884

Berlin, Germany, 10717

Actively Recruiting

116

Teva Investigational Site 32886

Berlin, Germany, 10787

Actively Recruiting

117

Teva Investigational Site 32893

Delitzsch, Germany, 04509

Actively Recruiting

118

Teva Investigational Site 32879

Frankfurt, Germany, 60596

Actively Recruiting

119

Teva Investigational Site 32892

Frankfurt, Germany, 60596

Actively Recruiting

120

Teva Investigational Site 32887

Leipzig, Germany, 04177

Actively Recruiting

121

Teva Investigational Site 32876

Leipzig, Germany, 04207

Actively Recruiting

122

Teva Investigational Site 32883

Leipzig - Nordost, Germany, 04347

Completed

123

Teva Investigational Site 32877

Magdeburg, Germany, 39120

Actively Recruiting

124

Teva Investigational Site 32878

Mainz A. Rhein, Germany, 55128

Actively Recruiting

125

Teva Investigational Site 32888

Neu-Isenburg, Germany, 63263

Actively Recruiting

126

Teva Investigational Site 32890

Peine, Germany, 31224

Actively Recruiting

127

Teva Investigational Site 32882

Rheine, Germany, 48431

Actively Recruiting

128

Teva Investigational Site 32889

Witten, Germany, 58452

Actively Recruiting

129

Teva Investigational Site 80207

Be’er Ya‘aqov, Israel, 70300

Completed

130

Teva Investigational Site 80206

Haifa, Israel, 3109601

Actively Recruiting

131

Teva Investigational Site 80208

Jerusalem, Israel, 91240

Actively Recruiting

132

Teva Investigational Site 21133

Chihuahua City, Mexico, 31203

Actively Recruiting

133

Teva Investigational Site 21134

Mexico City, Mexico, 14090

Actively Recruiting

134

Teva Investigational Site 21137

Morelia, Mexico, 58260

Actively Recruiting

135

Teva Investigational Site 21136

Tlalnepantla, Mexico, 54055

Actively Recruiting

136

Teva Investigational Site 21135

Zapopan, Mexico, 45138

Actively Recruiting

137

Teva Investigational Site 53582

Bialystok, Poland, 15-010

Actively Recruiting

138

Teva Investigational Site 53580

Bialystok, Poland, 15-430

Actively Recruiting

139

Teva Investigational Site 53578

Gdansk, Poland, 84-230

Completed

140

Teva Investigational Site 53575

Lodz, Poland, 90-127

Actively Recruiting

141

Teva Investigational Site 53576

Lodz, Poland, 95-002

Completed

142

Teva Investigational Site 53581

Maków Podhalański, Poland, 34-220

Actively Recruiting

143

Teva Investigational Site 53579

Poznan, Poland, 60-309

Actively Recruiting

144

Teva Investigational Site 53574

Tarnów, Poland, 70-332

Actively Recruiting

145

Teva Investigational Site 53577

Wroclaw, Poland, 50-381

Actively Recruiting

146

Teva Investigational Site 52148

Craiova, Romania, 410169

Actively Recruiting

147

Teva Investigational Site 52147

Oradea, Romania, 410169

Actively Recruiting

148

Teva Investigational Site 52145

Timișoara, Romania, 2447

Actively Recruiting

149

Teva Investigational Site 61090

Belgrade, Serbia, 11000

Actively Recruiting

150

Teva Investigational Site 61093

Belgrade, Serbia, 11000

Actively Recruiting

151

Teva Investigational Site 61092

Belgrade, Serbia, 11070

Actively Recruiting

152

Teva Investigational Site 61088

Belgrade, Serbia, 11080

Actively Recruiting

153

Teva Investigational Site 61094

Kragujevac, Serbia, 34000

Actively Recruiting

154

Teva Investigational Site 61095

Novi Sad, Serbia, 21000

Actively Recruiting

155

Teva Investigational Site 61091

Užice, Serbia, 501715

Actively Recruiting

156

Teva Investigational Site 62102

Košice, Slovakia, 04022

Actively Recruiting

157

Teva Investigational Site 62103

Martin, Slovakia, 03601

Completed

158

Teva Investigational Site 62104

Slovakia, Slovakia, 06224

Actively Recruiting

159

Teva Investigational Site 62101

Spišská Nová Ves, Slovakia, 05201

Actively Recruiting

160

Teva Investigational Site 82089

Adana, Turkey (Türkiye), 1330

Actively Recruiting

161

Teva Investigational Site 82085

Kirikkale, Turkey (Türkiye), 71450

Actively Recruiting

162

Teva Investigational Site 82088

Kocaeli, Turkey (Türkiye), 41140

Actively Recruiting

163

Teva Investigational Site 82087

Mersin, Turkey (Türkiye), 33343

Actively Recruiting

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Research Team

T

Teva U.S. Medical Information

CONTACT

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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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 | DecenTrialz