Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)
Study Details
Study Description
Brief Summary
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) relative to budesonide and formoterol fumarate MDI and Symbicort® pressurized MDI in adult and adolescent participants with inadequately controlled asthma. Approximately 2200 participants will be randomized globally.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) |
Drug: BGF MDI 320/28.8/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
Other Names:
|
Experimental: BGF MDI 320/14.4/9.6 μg BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) |
Drug: BGF MDI 320/14.4/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
Other Names:
|
Active Comparator: Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI) |
Drug: BFF MDI 320/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler
Other Names:
|
Active Comparator: Symbicort® Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg |
Drug: BFF pMDI 320/9 μg
Budesonide/formoterol fumarate pressurized metered dose inhaler
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 [24 Weeks]
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
- Rate of severe asthma exacerbations [Up to 52 Weeks]
Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations
Secondary Outcome Measures
- Change from baseline in morning pre-dose trough FEV1 at Week 24 [24 Weeks]
Change from baseline in morning pre-dose trough FEV1 at Week 24
- Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24 [24 Weeks]
Percentage of responders in ACQ-7 (≥0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008
- Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24 [24 Weeks]
Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008
- Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (≥0.5 increase equals response) at Week 24 [24 Weeks]
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (≥0.5 increase equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008
- Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24 [24 Weeks]
Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24
- Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 [Day 1]
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1
- Time to first severe asthma exacerbation [Up to 52 Weeks]
Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Time to first severe asthma exacerbation
- Rate of moderate/severe asthma exacerbations [Up to 52 Weeks]
Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of moderate/severe asthma exacerbations
- Time to first moderate/severe asthma exacerbation [Up to 52 Weeks]
Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Time to first moderate/severe asthma exacerbation
Eligibility Criteria
Criteria
Inclusion Criteria:
-
12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
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Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
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Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
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ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
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FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)
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Participants > and/or = 18 years of age: < 80%
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Participants 12 to <18 years of age: < 90%
- FEV1 post-albuterol at V2 or V3 (if repeat needed). • Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.
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Participants 12 to <18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3.
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Note: Reversibility testing is still required at Visit 2 and/or Visit 3, even if the patient has documented historical reversibility reported in the 12 months prior to Visit 1.
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Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
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Demonstrate acceptable MDI/pMDI administration technique.
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Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).
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eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).
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No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.
Exclusion Criteria:
- Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.
2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.
2b. Any marketed or investigational biologics within 3 months or 5 halflives of V1, whichever is longer and must not be used during study duration.
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Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
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Current evidence of COPD.
5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.
5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study.
5c. Depot corticosteroid use for any reason within 12 months of V1.
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Use of LAMA, either alone or as part of an inhaled combination therapy, in the 12 weeks prior to Visit 1.
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Use of oral b2-agonist within 3 months of V1.
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Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.
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Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.
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Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
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Hospitalization for asthma within 2 months of Visit 1.
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Known history of drug or alcohol abuse within 12 months of Visit 1.
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Regular use of a nebulizer or a home nebulizer for receiving asthma medications.
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Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration.
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Participation in another clinical study with an Investigational Product.
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Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI.
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Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
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For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.
Please refer to the study protocol for the complete inclusion and exclusion criteria list
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Research Site | Muscle Shoals | Alabama | United States | 35661 |
2 | Research Site | Chandler | Arizona | United States | 85224 |
3 | Research Site | Phoenix | Arizona | United States | 85051 |
4 | Research Site | Tucson | Arizona | United States | 85741 |
5 | Research Site | Conway | Arkansas | United States | 72032 |
6 | Research Site | Hot Springs National Park | Arkansas | United States | 71913 |
7 | Research Site | Little Rock | Arkansas | United States | 72205 |
8 | Research Site | Little Rock | Arkansas | United States | 72212 |
9 | Research Site | North Little Rock | Arkansas | United States | 72117 |
10 | Research Site | Anaheim | California | United States | 92805 |
11 | Research Site | Bakersfield | California | United States | 93301 |
12 | Research Site | Carlsbad | California | United States | 92009 |
13 | Research Site | Escondido | California | United States | 92025 |
14 | Research Site | Huntington Beach | California | United States | 92647 |
15 | Research Site | Huntington Beach | California | United States | 92647 |
16 | Research Site | Inglewood | California | United States | 90303 |
17 | Research Site | Lancaster | California | United States | 93534 |
18 | Research Site | Long Beach | California | United States | 90806 |
19 | Research Site | Long Beach | California | United States | 90806 |
20 | Research Site | Los Angeles | California | United States | 90033 |
21 | Research Site | Los Angeles | California | United States | 90048 |
22 | Research Site | Mission Viejo | California | United States | 92691 |
23 | Research Site | North Hollywood | California | United States | 91606 |
24 | Research Site | Northridge | California | United States | 91324 |
25 | Research Site | Orange | California | United States | 92868 |
26 | Research Site | Palmdale | California | United States | 93550 |
27 | Research Site | Sacramento | California | United States | 95825 |
28 | Research Site | San Diego | California | United States | 92103 |
29 | Research Site | San Diego | California | United States | 92120 |
30 | Research Site | San Jose | California | United States | 95117 |
31 | Research Site | Colorado Springs | Colorado | United States | 80910 |
32 | Research Site | Newark | Delaware | United States | 19713 |
33 | Research Site | Boca Raton | Florida | United States | 33487 |
34 | Research Site | Clearwater | Florida | United States | 33756 |
35 | Research Site | Clearwater | Florida | United States | 33765 |
36 | Research Site | Davenport | Florida | United States | 33896 |
37 | Research Site | Kissimmee | Florida | United States | 34746 |
38 | Research Site | Lakeland | Florida | United States | 33813 |
39 | Research Site | North Port | Florida | United States | 34287 |
40 | Research Site | Orlando | Florida | United States | 32807 |
41 | Research Site | Saint Petersburg | Florida | United States | 33704 |
42 | Research Site | Tampa | Florida | United States | 33615 |
43 | Research Site | Acworth | Georgia | United States | 30101 |
44 | Research Site | Alpharetta | Georgia | United States | 30022 |
45 | Research Site | Atlanta | Georgia | United States | 30322 |
46 | Research Site | Atlanta | Georgia | United States | 30342 |
47 | Research Site | Buford | Georgia | United States | 30518 |
48 | Research Site | Fayetteville | Georgia | United States | 30214 |
49 | Research Site | Hinesville | Georgia | United States | 31313 |
50 | Research Site | Newnan | Georgia | United States | 30265 |
51 | Research Site | Peachtree City | Georgia | United States | 30269 |
52 | Research Site | Snellville | Georgia | United States | 30078 |
53 | Research Site | Stone Mountain | Georgia | United States | 30083 |
54 | Research Site | Boise | Idaho | United States | 83706 |
55 | Research Site | Chicago | Illinois | United States | 60621 |
56 | Research Site | Chicago | Illinois | United States | 60641 |
57 | Research Site | Normal | Illinois | United States | 61761 |
58 | Research Site | Evansville | Indiana | United States | 47715 |
59 | Research Site | Marrero | Louisiana | United States | 70072 |
60 | Research Site | Zachary | Louisiana | United States | 70791 |
61 | Research Site | Baltimore | Maryland | United States | 21224 |
62 | Research Site | White Marsh | Maryland | United States | 21162 |
63 | Research Site | Fall River | Massachusetts | United States | 02723 |
64 | Research Site | North Dartmouth | Massachusetts | United States | 02747 |
65 | Research Site | Caro | Michigan | United States | 48723 |
66 | Research Site | Farmington Hills | Michigan | United States | 48336 |
67 | Research Site | Rochester | Michigan | United States | 48307 |
68 | Research Site | Troy | Michigan | United States | 48085 |
69 | Research Site | Chesterfield | Missouri | United States | 63017 |
70 | Research Site | Saint Louis | Missouri | United States | 63141 |
71 | Research Site | Warrensburg | Missouri | United States | 64093 |
72 | Research Site | Brick | New Jersey | United States | 08724 |
73 | Research Site | Albuquerque | New Mexico | United States | 87102 |
74 | Research Site | Bronx | New York | United States | 10459 |
75 | Research Site | Bronx | New York | United States | 10461 |
76 | Research Site | Bronx | New York | United States | 10468 |
77 | Research Site | Brooklyn | New York | United States | 11236 |
78 | Research Site | Corning | New York | United States | 14830 |
79 | Research Site | New York | New York | United States | 10036 |
80 | Research Site | North Massapequa | New York | United States | 11758 |
81 | Research Site | Port Jefferson | New York | United States | 11766 |
82 | Research Site | Rochester | New York | United States | 14642 |
83 | Research Site | Charlotte | North Carolina | United States | 28210 |
84 | Research Site | Elizabeth City | North Carolina | United States | 27909 |
85 | Research Site | Greensboro | North Carolina | United States | 27408 |
86 | Research Site | High Point | North Carolina | United States | 27262 |
87 | Research Site | Huntersville | North Carolina | United States | 28078 |
88 | Research Site | Monroe | North Carolina | United States | 28112 |
89 | Research Site | Oklahoma City | Oklahoma | United States | 73106 |
90 | Research Site | Portland | Oregon | United States | 97202 |
91 | Research Site | Jenkintown | Pennsylvania | United States | 19046 |
92 | Research Site | Philadelphia | Pennsylvania | United States | 19107 |
93 | Research Site | Philadelphia | Pennsylvania | United States | 19140 |
94 | Research Site | Pittsburgh | Pennsylvania | United States | 15212 |
95 | Research Site | Johnston | Rhode Island | United States | 02919 |
96 | Research Site | Rock Hill | South Carolina | United States | 29732 |
97 | Research Site | Spartanburg | South Carolina | United States | 29303 |
98 | Research Site | Hendersonville | Tennessee | United States | 37075 |
99 | Research Site | Knoxville | Tennessee | United States | 37909 |
100 | Research Site | Cedar Park | Texas | United States | 78613 |
101 | Research Site | Conroe | Texas | United States | 77384 |
102 | Research Site | Corsicana | Texas | United States | 75110 |
103 | Research Site | Dallas | Texas | United States | 75230 |
104 | Research Site | Denison | Texas | United States | 75020 |
105 | Research Site | Denison | Texas | United States | 75020 |
106 | Research Site | Houston | Texas | United States | 77004 |
107 | Research Site | Houston | Texas | United States | 77074 |
108 | Research Site | Lewisville | Texas | United States | 75067 |
109 | Research Site | McAllen | Texas | United States | 78504 |
110 | Research Site | McKinney | Texas | United States | 75069 |
111 | Research Site | McKinney | Texas | United States | 75071 |
112 | Research Site | McKinney | Texas | United States | 75071 |
113 | Research Site | Mesquite | Texas | United States | 75149 |
114 | Research Site | North Richland Hills | Texas | United States | 76180 |
115 | Research Site | Pearland | Texas | United States | 77584 |
116 | Research Site | Pflugerville | Texas | United States | 78660 |
117 | Research Site | Pharr | Texas | United States | 78577 |
118 | Research Site | Plano | Texas | United States | 75093 |
119 | Research Site | San Antonio | Texas | United States | 78229 |
120 | Research Site | Sugar Land | Texas | United States | 77478 |
121 | Research Site | Sugar Land | Texas | United States | 77479 |
122 | Research Site | Abingdon | Virginia | United States | 24210 |
123 | Research Site | Burke | Virginia | United States | 22015 |
124 | Research Site | Williamsburg | Virginia | United States | 23188 |
125 | Research Site | Milwaukee | Wisconsin | United States | 53226 |
126 | Research Site | Milwaukee | Wisconsin | United States | 53228 |
127 | Research Site | Bludenz | Austria | 6700 | |
128 | Research Site | Feldbach | Austria | A-8330 | |
129 | Research Site | Linz | Austria | 4020 | |
130 | Research Site | Thalheim | Austria | 4600 | |
131 | Research Site | Botucatu | Brazil | 18618-970 | |
132 | Research Site | Porto Alegre | Brazil | 9002-060 | |
133 | Research Site | Porto Alegre | Brazil | 90430-001 | |
134 | Research Site | Porto Alegre | Brazil | 90610-000 | |
135 | Research Site | Porto Alegre | Brazil | 91350-200 | |
136 | Research Site | Santo Andre | Brazil | 09080-110 | |
137 | Research Site | Sorocaba | Brazil | 18040-425 | |
138 | Research Site | São Paulo | Brazil | 05403-000 | |
139 | Research Site | Uberlandia | Brazil | 38411-186 | |
140 | Research Site | Anhui | China | 230061 | |
141 | Research Site | Baotou | China | 014010 | |
142 | Research Site | Beijing | China | 100020 | |
143 | Research Site | Beijing | China | ||
144 | Research Site | Changchun | China | ||
145 | Research Site | Changsha | China | 410005 | |
146 | Research Site | Changsha | China | 410008 | |
147 | Research Site | Changsha | China | 430033 | |
148 | Research Site | Chongqing | China | 400010 | |
149 | Research Site | Chongqing | China | 400038 | |
150 | Research Site | Fuzhou | China | 350025 | |
151 | Research Site | Gongguan | China | ||
152 | Research Site | Guangzhou | China | 510062 | |
153 | Research Site | Guangzhou | China | 510120 | |
154 | Research Site | Guangzhou | China | 510180 | |
155 | Research Site | Guangzhou | China | 510280 | |
156 | Research Site | Guangzhou | China | 510630 | |
157 | Research Site | Guangzhou | China | ||
158 | Research Site | Guiyang | China | 550002 | |
159 | Research Site | Haikou | China | 570208 | |
160 | Research Site | Haikou | China | 570311 | |
161 | Research Site | Hangzhou | China | 310005 | |
162 | Research Site | Hangzhou | China | 310006 | |
163 | Research Site | Hangzhou | China | 310009 | |
164 | Research Site | Hefei | China | 230000 | |
165 | Research Site | Hefei | China | 230022 | |
166 | Research Site | Hohhot | China | 010017 | |
167 | Research Site | Huai'an | China | 223300 | |
168 | Research Site | Huizhou | China | 516001 | |
169 | Research Site | Jinan | China | 250001 | |
170 | Research Site | Jinan | China | 250021 | |
171 | Research Site | Jinan | China | 250117 | |
172 | Research Site | Jinhua | China | 321000 | |
173 | Research Site | Kunming | China | 650032 | |
174 | Research Site | Lanzhou | China | 730000 | |
175 | Research Site | Luoyang | China | 471003 | |
176 | Research Site | Nan Chong | China | 637000 | |
177 | Research Site | Nanchang | China | 330006 | |
178 | Research Site | Nanjing | China | 210006 | |
179 | Research Site | Nanjing | China | 210008 | |
180 | Research Site | Nanjing | China | 210009 | |
181 | Research Site | Nanjing | China | 210029 | |
182 | Research Site | Nanning | China | 530021 | |
183 | Research Site | Qingdao | China | 266000 | |
184 | Research Site | Shanghai | China | 2000127 | |
185 | Research Site | Shanghai | China | 200025 | |
186 | Research Site | Shanghai | China | 200032 | |
187 | Research Site | Shanghai | China | 200065 | |
188 | Research Site | Shanghai | China | 200080 | |
189 | Research Site | Shanghai | China | 200092 | |
190 | Research Site | Shanghai | China | 200233 | |
191 | Research Site | Shanghai | China | 200240 | |
192 | Research Site | Shanghai | China | 200433 | |
193 | Research Site | Shanghai | China | 201199 | |
194 | Research Site | Shangrao | China | 334000 | |
195 | Research Site | Shantou | China | 515041 | |
196 | Research Site | Shaoxing | China | 312000 | |
197 | Research Site | Shengyang | China | 110004 | |
198 | Research Site | Shenyang | China | 110001 | |
199 | Research Site | Shenyang | China | 110015 | |
200 | Research Site | Shenzhen | China | 518020 | |
201 | Research Site | Shenzhen | China | 518036 | |
202 | Research Site | Shenzhen | China | 518039 | |
203 | Research Site | Shihezi | China | 830000 | |
204 | Research Site | Shijiazhuang | China | 50051 | |
205 | Research Site | Tai'an | China | 271000 | |
206 | Research Site | Taiyuan | China | 030001 | |
207 | Research Site | Taizhou | China | 318020 | |
208 | Research Site | Urumqi | China | 830054 | |
209 | Research Site | Wenzhou | China | 325027 | |
210 | Research Site | Wuhan | China | 430010 | |
211 | Research Site | Wuhan | China | 430030 | |
212 | Research Site | Wuhu | China | 241000 | |
213 | Research Site | Xi'an | China | 710004 | |
214 | Research Site | Xian | China | 710061 | |
215 | Research Site | Xuzhou | China | 221000 | |
216 | Research Site | Xuzhou | China | 221009 | |
217 | Research Site | Xuzhou | China | ||
218 | Research Site | Yangzhou | China | 225001 | |
219 | Research Site | Yinchuan | China | 750001 | |
220 | Research Site | Yinchuan | China | 750004 | |
221 | Research Site | Zhanjiang | China | 524001 | |
222 | Research Site | Zhengzhou City | China | 450000 | |
223 | Research Site | Zhengzhou | China | 450000 | |
224 | Research Site | Zhuji | China | ||
225 | Research Site | Bogota | Colombia | 110221 | |
226 | Research Site | Cartagena | Colombia | 130013 | |
227 | Research Site | Manizales | Colombia | 17001 | |
228 | Research Site | Medellin | Colombia | 050034 | |
229 | Research Site | Rionegro | Colombia | 54040 | |
230 | Research Site | San Gil | Colombia | 684031 | |
231 | Research Site | San José | Costa Rica | 10103 | |
232 | Research Site | Santa Ana | Costa Rica | 10903 | |
233 | Research Site | Brandys nad Labem | Czechia | 250 01 | |
234 | Research Site | Jindrichuv Hradec | Czechia | 377 01 | |
235 | Research Site | Liberec | Czechia | 460 01 | |
236 | Research Site | Lovosice | Czechia | 410 02 | |
237 | Research Site | Mlada Boleslav | Czechia | 293 01 | |
238 | Research Site | Novy Bor | Czechia | 473 01 | |
239 | Research Site | Praha 9 | Czechia | 190 00 | |
240 | Research Site | Rokycany | Czechia | 337 22 | |
241 | Research Site | Strakonice | Czechia | 38601 | |
242 | Research Site | Teplice | Czechia | 415 01 | |
243 | Research Site | Varnsdorf | Czechia | 407 47 | |
244 | Research Site | Bamberg | Germany | 96049 | |
245 | Research Site | Berlin | Germany | 10119 | |
246 | Research Site | Berlin | Germany | 10367 | |
247 | Research Site | Berlin | Germany | 10717 | |
248 | Research Site | Berlin | Germany | 12159 | |
249 | Research Site | Berlin | Germany | 12203 | |
250 | Research Site | Berlin | Germany | 13057 | |
251 | Research Site | Berlin | Germany | 13187 | |
252 | Research Site | Berlin | Germany | 13187 | |
253 | Research Site | Darmstadt | Germany | 64283 | |
254 | Research Site | Duisburg | Germany | 47057 | |
255 | Research Site | Frankfurt am Main | Germany | 60596 | |
256 | Research Site | Frankfurt/Main | Germany | 60389 | |
257 | Research Site | Frankfurt | Germany | 60596 | |
258 | Research Site | Geesthacht | Germany | 21502 | |
259 | Research Site | Hannover | Germany | D-30173 | |
260 | Research Site | Koblenz | Germany | 56068 | |
261 | Research Site | Leipzig | Germany | 04103 | |
262 | Research Site | Leipzig | Germany | 04207 | |
263 | Research Site | Leipzig | Germany | 04299 | |
264 | Research Site | Leipzig | Germany | 04357 | |
265 | Research Site | Mainz | Germany | 55128 | |
266 | Research Site | Marburg | Germany | 35037 | |
267 | Research Site | München-Pasing | Germany | 81241 | |
268 | Research Site | Alexandroupolis | Greece | 68100 | |
269 | Research Site | Athens | Greece | 11525 | |
270 | Research Site | Athens | Greece | 11527 | |
271 | Research Site | Athens | Greece | 11527 | |
272 | Research Site | Athens | Greece | 12462 | |
273 | Research Site | Athens | Greece | 17562 | |
274 | Research Site | Exohi Thessaloniki | Greece | 57010 | |
275 | Research Site | Heraklion | Greece | 71110 | |
276 | Research Site | Ioannina | Greece | 45500 | |
277 | Research Site | Patras | Greece | 26500 | |
278 | Research Site | Thessaloniki | Greece | 56429 | |
279 | Research Site | Thessaloniki | Greece | 57010 | |
280 | Research Site | Ashqelon | Israel | 7830604 | |
281 | Research Site | Beer Sheva | Israel | 84101 | |
282 | Research Site | Haifa | Israel | 31096 | |
283 | Research Site | Haifa | Israel | 34362 | |
284 | Research Site | Jerusalem | Israel | 9103102 | |
285 | Research Site | Jerusalem | Israel | 9112001 | |
286 | Research Site | Kfar Saba | Israel | 4428164 | |
287 | Research Site | Petach-Tikva | Israel | 4920235 | |
288 | Research Site | Petah Tikva | Israel | 4920235 | |
289 | Research Site | Ramat-Gan | Israel | 52621 | |
290 | Research Site | Rehovot | Israel | 76100 | |
291 | Research Site | Tel Aviv | Israel | 6423906 | |
292 | Research Site | Ciudad de Mexico | Mexico | 6700 | |
293 | Research Site | Culiacán | Mexico | 80200 | |
294 | Research Site | Durango | Mexico | 43080 | |
295 | Research Site | Guadalajara | Mexico | 44200 | |
296 | Research Site | Mazatlán | Mexico | 82000 | |
297 | Research Site | Monterrey | Mexico | 64620 | |
298 | Research Site | Monterrey | Mexico | 64710 | |
299 | Research Site | Monterrey | Mexico | 64718 | |
300 | Research Site | Puebla | Mexico | 72190 | |
301 | Research Site | Veracruz | Mexico | 91910 | |
302 | Research Site | Villahermosa | Mexico | 86035 | |
303 | Research Site | Amadora | Portugal | 2720-276 | |
304 | Research Site | Barcelos | Portugal | 4750-333 | |
305 | Research Site | Braga | Portugal | 4710 | |
306 | Research Site | Guarda | Portugal | 6300-035 | |
307 | Research Site | Guimaraes | Portugal | 4835-044 | |
308 | Research Site | Lisboa | Portugal | 1998-018 | |
309 | Research Site | Matosinhos | Portugal | 4454-509 | |
310 | Research Site | Vila Nova de Gaia | Portugal | 4434-502 | |
311 | Research Site | Ponce | Puerto Rico | 00717 | |
312 | Research Site | Ponce | Puerto Rico | 00780 | |
313 | Research Site | Chelyabinsk | Russian Federation | 454106 | |
314 | Research Site | Izhevsk | Russian Federation | 426035 | |
315 | Research Site | Kazan | Russian Federation | 420008 | |
316 | Research Site | Kemerovo | Russian Federation | 650002 | |
317 | Research Site | Kirov | Russian Federation | 610014 | |
318 | Research Site | Moscow | Russian Federation | 115522 | |
319 | Research Site | Moscow | Russian Federation | 125284 | |
320 | Research Site | Omsk | Russian Federation | 644033 | |
321 | Research Site | Penza | Russian Federation | 440067 | |
322 | Research Site | Perm | Russian Federation | 614000 | |
323 | Research Site | Saint Petersburg | Russian Federation | 194354 | |
324 | Research Site | Saint Petersburg | Russian Federation | 195257 | |
325 | Research Site | Saratov | Russian Federation | 410012 | |
326 | Research Site | Saratov | Russian Federation | 410028 | |
327 | Research Site | Saratov | Russian Federation | 410053 | |
328 | Research Site | Tomsk | Russian Federation | 634050 | |
329 | Research Site | Ulyanovsk | Russian Federation | 432009 | |
330 | Research Site | Ar Riyāḑ | Saudi Arabia | 11426 | |
331 | Research Site | Jeddah | Saudi Arabia | 21423 | |
332 | Research Site | Jeddah | Saudi Arabia | 22252 | |
333 | Research Site | Makkah | Saudi Arabia | 24246 | |
334 | Research Site | Riyadh | Saudi Arabia | 1121 | |
335 | Research Site | Riyadh | Saudi Arabia | 12231 | |
336 | Research Site | Riyadh | Saudi Arabia | 12233 | |
337 | Research Site | Riyadh | Saudi Arabia | 12713 | |
338 | Research Site | Bojnice | Slovakia | 972 01 | |
339 | Research Site | Kezmarok | Slovakia | 060 01 | |
340 | Research Site | Kosice | Slovakia | 04022 | |
341 | Research Site | Levice | Slovakia | 934 01 | |
342 | Research Site | Nove Zamky | Slovakia | 940 01 | |
343 | Research Site | Nove Zamky | Slovakia | 94001 | |
344 | Research Site | Poprad | Slovakia | 058 01 | |
345 | Research Site | Ruzomberok | Slovakia | 034 26 | |
346 | Research Site | Surany | Slovakia | 94201 | |
347 | Research Site | Topolcany | Slovakia | 95501 | |
348 | Research Site | Bellville | South Africa | 7530 | |
349 | Research Site | Bloemfontein | South Africa | 9301 | |
350 | Research Site | Cape Town | South Africa | 7570 | |
351 | Research Site | Cape Town | South Africa | 7700 | |
352 | Research Site | Cape Town | South Africa | 7764 | |
353 | Research Site | Durban | South Africa | 4001 | |
354 | Research Site | Durban | South Africa | 4091 | |
355 | Research Site | Durban | South Africa | 4093 | |
356 | Research Site | Durban | South Africa | 4450 | |
357 | Research Site | Johannesburg | South Africa | 2001 | |
358 | Research Site | Johannesburg | South Africa | 2013 | |
359 | Research Site | Lenasia Ext8 | South Africa | 1820 | |
360 | Research Site | Lenasia South | South Africa | 1835 | |
361 | Research Site | Panorama | South Africa | 7500 | |
362 | Research Site | Pretoria | South Africa | 0186 | |
363 | Research Site | Umkomaas | South Africa | 4170 | |
364 | Research Site | Lund | Sweden | 222 22 | |
365 | Research Site | Stockholm | Sweden | 111 20 | |
366 | Research Site | Uppsala | Sweden | 75237 | |
367 | Research Site | Adana | Turkey | 01330 | |
368 | Research Site | Ankara | Turkey | 06280 | |
369 | Research Site | Ankara | Turkey | 06 | |
370 | Research Site | Istanbul | Turkey | 34010 | |
371 | Research Site | Istanbul | Turkey | 34098 | |
372 | Research Site | İstanbul | Turkey | 34844 | |
373 | Research Site | Izmir | Turkey | 35110 | |
374 | Research Site | Manisa | Turkey | 45030 | |
375 | Research Site | Mersin | Turkey | 33079 | |
376 | Research Site | Pamukkale | Turkey | 20070 | |
377 | Research Site | Blackpool | United Kingdom | FY3 7EN | |
378 | Research Site | Bradford | United Kingdom | BD9 6RJ | |
379 | Research Site | Corby | United Kingdom | NN17 2UR | |
380 | Research Site | Hull | United Kingdom | HU16 5JQ | |
381 | Research Site | Leicester | United Kingdom | LE5 4LJ | |
382 | Research Site | Rhyl | United Kingdom | LL18 1DA |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Principal Investigator: Robert Wise, MD, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D5982C00008
- 2020-001521-31