BOREAS: Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation

• Sponsor: Sanofi (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03930732
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 939
• Locations: 287
• Arms: 2
• Anticipated Duration (Months): 48.6
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Primary Objective:

To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by

• Annualized rate of acute moderate and severe COPD exacerbation (AECOPD)

Secondary Objectives:

To evaluate the effect of dupilumab administered every 2 weeks on

• Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo

• Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ)

• Pre-bronchodilator FEV1 over 52 weeks compared to placebo

• Lung function assessments

• Moderate and severe COPD exacerbations

• To evaluate safety and tolerability

• To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies (ADA)

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Dupilumab SAR231893; Drug: Inhaled Corticosteroid; Drug: Inhaled Long-Acting Beta Agonist; Drug: Inhaled Long-Acting Muscarinic Antagonist; Drug: Placebo	Phase 3

Detailed Description

Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up.

Study Design

• Study Type: Interventional
• Actual Enrollment: 939 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation
• Actual Study Start Date: Apr 15, 2019
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: May 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dupilumab Dupilumab administered every 2 weeks	Drug: Dupilumab SAR231893; Pharmaceutical form: Solution for injection Route of administration: Subcutaneous; Other Names: Dupixent ; Drug: Inhaled Corticosteroid; Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation; Drug: Inhaled Long-Acting Beta Agonist; Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation; Drug: Inhaled Long-Acting Muscarinic Antagonist; Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Placebo Comparator: Placebo Placebo dose administered every 2 weeks	Drug: Inhaled Corticosteroid; Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation; Drug: Inhaled Long-Acting Beta Agonist; Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation; Drug: Inhaled Long-Acting Muscarinic Antagonist; Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation; Drug: Placebo; Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Outcome Measures

Primary Outcome Measures

1. Annual rate of acute COPD exacerbation (AECOPD) [Baseline to Week 52]

   Annualized rate of moderate or severe COPD exacerbations over the 52-week treatment period compared to placebo

Secondary Outcome Measures

1. Change in pre-bronchodilator FEV1 [Baseline to Week 12]

   Change in pre-bronchodilator FEV1 from baseline to Week 12 compared to placebo

2. Change in SGRQ [Baseline to Week 52]

   Change from baseline to Week 52 in SGRQ total score compared to placebo

3. Improvement in SGRQ [Baseline to Week 52]

   Proportion of patients with SGRQ improvement ≥4 points at Week 52

4. Change in pre-bronchodilator FEV1 from baseline to Week 52 [Baseline to Week 52]

   Change in pre-bronchodilator FEV1 from baseline to Week 52 compared to placebo

5. Change in pre-bronchodilator FEV1 from baseline to time points up to Week 44 [Baseline to Weeks 2, 4, 8, 24, 36, 44]

   Change in pre-bronchodilator FEV1 from baseline to weeks other than 12 and 52 (i.e. Weeks 2, 4, 8, 24, 36, and 44) compared to placebo

6. Change in post-bronchodilator FEV1 lung function [Baseline to Weeks 2, 4, 8, 12, 24, 36, 52]

   Change in post-bronchodilator FEV1 from baseline at Weeks 2, 4, 8, 12, 24, 36 and 52 compared to placebo

7. Change in forced expiratory flow (FEF) 25-75% [Baseline to Weeks 2, 4, 8, 12, 24, 36, 44, 52]

   Change in FEF 25-75% from baseline to Weeks 2, 4, 8, 12, 24, 36, 44 and 52

8. Annualized rate of severe AECOPD [Baseline through Week 52]

   Annualized rate of severe COPD exacerbations compared to placebo over the 52-week treatment period

9. Time to first AECOPD [Baseline through Week 52]

   Time to first moderate or severe COPD exacerbation compared with placebo during the 52-week treatment period

10. Adverse events [Baseline through Week 64]

    Number of adverse events (AEs)/treatment-emergent adverse events (TEAEs)

11. Potentially clinically significant abnormality (PCSA) in laboratory tests [Baseline through Week 64]

    Percentage of patients with at least one incidence of PCSA

12. Anti-drug antibodies [Baseline to Week 64]

    Incidence of anti-drug antibodies against dupilumab

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Participants with a physician diagnosis of COPD who meet the following criteria at screening:

• Current or former smokers with a smoking history of ≥10 pack-years.

• Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] ratio <0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%).

• Medical Research Council (MRC) Dyspnea Scale grade ≥2.

• Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.

• Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the patient was taking inhaled corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations are recorded by the investigator and defined as acute exacerbation of COPD (AECOPD) that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteroids. Severe exacerbations are recorded by the investigator and defined as AECOPD requiring hospitalization or observation >24 hours in emergency department/urgent care facility.

• Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.

• Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1.

Exclusion criteria:

• COPD diagnosis for less than 12 months prior to randomization.

• A current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.

• Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.

• Cor pulmonale, evidence of right cardiac failure.

• Treatment with oxygen of more than 12 hours per day.

• Hypercapnia requiring Bi-level ventilation.

• AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period.

• Respiratory tract infection within 4 weeks prior to screening, or during the screening period.

• History of, or planned pneumonectomy or lung volume reduction surgery. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program can be included).

• Diagnosis of α-1 anti-trypsin deficiency.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number :8400030	Andalusia	Alabama	United States	36420
2	Investigational Site Number :8400041	Birmingham	Alabama	United States	35209
3	Investigational Site Number :8400013	Birmingham	Alabama	United States	35294
4	Investigational Site Number :8400059	Dothan	Alabama	United States	36303
5	Investigational Site Number :8400057	Mobile	Alabama	United States	36608
6	Investigational Site Number :8400043	Tucson	Arizona	United States	85724
7	Investigational Site Number :8400034	Colorado Springs	Colorado	United States	80907
8	Investigational Site Number :8400010	Clearwater	Florida	United States	33765
9	Investigational Site Number :8400014	Greenacres City	Florida	United States	33467
10	Investigational Site Number :8400023	Miami	Florida	United States	33125
11	Investigational Site Number :8400062	Miami	Florida	United States	33126
12	Investigational Site Number :8400051	Ocala	Florida	United States	34470
13	Investigational Site Number :8400029	Orlando	Florida	United States	32825
14	Investigational Site Number :8400032	Panama City	Florida	United States	32405
15	Investigational Site Number :8400026	Sarasota	Florida	United States	34239
16	Investigational Site Number :8400055	Dacula	Georgia	United States	30019
17	Investigational Site Number :8400020	Decatur	Georgia	United States	30033
18	Investigational Site Number :8400016	Marietta	Georgia	United States	30060
19	Investigational Site Number :8400025	Woodstock	Georgia	United States	30189
20	Investigational Site Number :8400012	Baltimore	Maryland	United States	21224
21	Investigational Site Number :8400038	White Marsh	Maryland	United States	21162
22	Investigational Site Number :8400050	Ann Arbor	Michigan	United States	48109
23	Investigational Site Number :8400065	Rochester	Minnesota	United States	55905
24	Investigational Site Number :8400071	Jackson	Mississippi	United States	39157
25	Investigational Site Number :8400011	Saint Charles	Missouri	United States	63301
26	Investigational Site Number :8400004	Saint Louis	Missouri	United States	63104
27	Investigational Site Number :8400035	Las Vegas	Nevada	United States	89106
28	Investigational Site Number :8400067	Buffalo	New York	United States	14215
29	Investigational Site Number :8400070	New York	New York	United States	10036
30	Investigational Site Number :8400019	Chapel Hill	North Carolina	United States	27514
31	Investigational Site Number :8400061	Charlotte	North Carolina	United States	28277
32	Investigational Site Number :8400064	Durham	North Carolina	United States	27705
33	Investigational Site Number :8400052	Wilmington	North Carolina	United States	28401
34	Investigational Site Number :8400060	Winston-Salem	North Carolina	United States	27103-4027
35	Investigational Site Number :8400031	Cleveland	Ohio	United States	44195
36	Investigational Site Number :8400040	Dayton	Ohio	United States	45459
37	Investigational Site Number :8400024	Dublin	Ohio	United States	43016
38	Investigational Site Number :8400005	Edmond	Oklahoma	United States	73034
39	Investigational Site Number :8400001	Medford	Oregon	United States	97504
40	Investigational Site Number :8400037	Clairton	Pennsylvania	United States	15025
41	Investigational Site Number :8400009	Philadelphia	Pennsylvania	United States	19140
42	Investigational Site Number :8400033	Pittsburgh	Pennsylvania	United States	15213
43	Investigational Site Number :8400063	Wyomissing	Pennsylvania	United States	19610
44	Investigational Site Number :8400022	Easley	South Carolina	United States	29640
45	Investigational Site Number :8400047	Gaffney	South Carolina	United States	29340
46	Investigational Site Number :8400007	Greenville	South Carolina	United States	29615
47	Investigational Site Number :8400044	Mount Pleasant	South Carolina	United States	29464
48	Investigational Site Number :8400046	Rock Hill	South Carolina	United States	29732
49	Investigational Site Number :8400048	Spartanburg	South Carolina	United States	29303
50	Investigational Site Number :8400073	Franklin	Tennessee	United States	37067
51	Investigational Site Number :8400002	Galveston	Texas	United States	77555
52	Investigational Site Number :8400018	Houston	Texas	United States	77030
53	Investigational Site Number :8400021	McKinney	Texas	United States	75069
54	Investigational Site Number :8400027	Sherman	Texas	United States	75092
55	Investigational Site Number :8400036	Tacoma	Washington	United States	98405
56	Investigational Site Number :8400008	Greenfield	Wisconsin	United States	53228
57	Investigational Site Number :0320011	Caba	Buenos Aires	Argentina	1430
58	Investigational Site Number :0320002	Caba	Buenos Aires	Argentina	C1414AIF
59	Investigational Site Number :0320003	Caba	Buenos Aires	Argentina	C1425BEN
60	Investigational Site Number :0320004	Caba	Buenos Aires	Argentina	C1425FVH
61	Investigational Site Number :0320012	La Plata	Buenos Aires	Argentina	B1900BNN
62	Investigational Site Number :0320007	Quilmes	Ciudad De Buenos Aires	Argentina	B1878FNR
63	Investigational Site Number :0320006	Rosario	Santa Fe	Argentina	S2000DBS
64	Investigational Site Number :0320009	San Miguel de Tucumán	Tucumán	Argentina	T4000IAR
65	Investigational Site Number :0320001	Buenos Aires		Argentina	C1121ABE
66	Investigational Site Number :0320005	Buenos Aires		Argentina
67	Investigational Site Number :0320008	Mar Del Plata		Argentina	B7600
68	Investigational Site Number :0320010	Mendoza		Argentina	5500
69	Investigational Site Number :1001004	Haskovo		Bulgaria	6305
70	Investigational Site Number :1001003	Montana		Bulgaria	3400
71	Investigational Site Number :1001006	Ruse		Bulgaria	7002
72	Investigational Site Number :1001009	Sofia		Bulgaria	1202
73	Investigational Site Number :1001002	Sofia		Bulgaria	1233
74	Investigational Site Number :1001001	Sofia		Bulgaria	1680
75	Investigational Site Number :1001005	Stara Zagora		Bulgaria	6001
76	Investigational Site Number :1001010	Troyan		Bulgaria	5600
77	Investigational Site Number :1240021	Edmonton	Alberta	Canada	T5H4B9
78	Investigational Site Number :1240015	Edmonton	Alberta	Canada	T6G 2G3
79	Investigational Site Number :1240016	Sherwood Park	Alberta	Canada	T8H 0N2
80	Investigational Site Number :1240017	Vancouver	British Columbia	Canada	V5Z 1M9
81	Investigational Site Number :1240007	Vancouver	British Columbia	Canada	V6Z 1Y6
82	Investigational Site Number :1240002	Burlington	Ontario	Canada	L7N 3V2
83	Investigational Site Number :1240012	Toronto	Ontario	Canada	M5T 3A9
84	Investigational Site Number :1240013	Windsor	Ontario	Canada	N8X 5A6
85	Investigational Site Number :1240009	Montreal	Quebec	Canada	H1M 1B1
86	Investigational Site Number :1240003	Montreal	Quebec	Canada	H1T 1C8
87	Investigational Site Number :1240001	Montreal	Quebec	Canada	H4A 3J1
88	Investigational Site Number :1240010	Sherbrooke	Quebec	Canada	J1H 5N4
89	Investigational Site Number :1240011	Sherbrooke	Quebec	Canada	J1L 0H8
90	Investigational Site Number :1240006	St-charles Borrommee	Quebec	Canada	J6E 2B4
91	Investigational Site Number :1240008	Trois-Rivieres	Quebec	Canada	G8T 7A1
92	Investigational Site Number :1240020	Victoriaville	Quebec	Canada	G6P 6P6
93	Investigational Site Number :1240014	Saskatoon	Saskatchewan	Canada	S7N 0W8
94	Investigational Site Number :1240005	Quebec		Canada	G1V 4G5
95	Investigational Site Number :1240004	Quebec		Canada	G1V 4W2
96	Investigational Site Number :1240019	Quebec		Canada	G3K 2P8
97	Investigational Site Number :1240018	Quebec		Canada	GIS 2L6
98	Investigational Site Number :1520006	Curicó	Maule	Chile	3341643
99	Investigational Site Number :1520001	Talca	Maule	Chile
100	Investigational Site Number :1520009	Santiago	Reg Metropolitana De Santiago	Chile	7500587
101	Investigational Site Number :1520003	Santiago	Reg Metropolitana De Santiago	Chile	7500692
102	Investigational Site Number :1520005	Santiago	Reg Metropolitana De Santiago	Chile	7500698
103	Investigational Site Number :1520008	Santiago	Reg Metropolitana De Santiago	Chile	8380453
104	Investigational Site Number :1520002	Santiago	Reg Metropolitana De Santiago	Chile	8910131
105	Investigational Site Number :1520004	Quillota	Valparaíso	Chile	2260877
106	Investigational Site Number :1560037	Baotou		China	014010
107	Investigational Site Number :1560006	Beijing		China
108	Investigational Site Number :1560003	Changchun		China	130021
109	Investigational Site Number :1560022	Changsha		China	410011
110	Investigational Site Number :1560021	Changsha		China	410013
111	Investigational Site Number :1560001	Chengdu		China	610041
112	Investigational Site Number :1560017	Chengdu		China	611130
113	Investigational Site Number :1560012	Chongqing		China	400037
114	Investigational Site Number :1560005	Chongqing		China	400038
115	Investigational Site Number :1560053	Fuzhou		China	350001
116	Investigational Site Number :1560019	Guangzhou		China	510120
117	Investigational Site Number :1560036	Guangzhou		China	510150
118	Investigational Site Number :1560045	Haikou		China	570216
119	Investigational Site Number :1560018	Haikou		China	570311
120	Investigational Site Number :1560046	Hangzhou		China	310009
121	Investigational Site Number :1560009	Hefei		China	230022
122	Investigational Site Number :1560041	Hefei		China
123	Investigational Site Number :1560015	Hohhot		China	010017
124	Investigational Site Number :1560008	Hohhot		China	010050
125	Investigational Site Number :1560027	Nanchang		China	330006
126	Investigational Site Number :1560034	Nanjing		China	210009
127	Investigational Site Number :1560032	Shanghai		China	200025
128	Investigational Site Number :1560013	Shanghai		China	200080
129	Investigational Site Number :1560007	Shanghai		China	200433
130	Investigational Site Number :1560014	Shenyang		China	110001
131	Investigational Site Number :1560004	Shenyang		China	110004
132	Investigational Site Number :1560051	Shenzhen		China	518020
133	Investigational Site Number :1560016	Shijiazhuang		China	050000
134	Investigational Site Number :1560024	Taiyuan		China	030001
135	Investigational Site Number :1560010	Tianjin		China	300052
136	Investigational Site Number :1560028	Urumchi		China	830054
137	Investigational Site Number :1560052	Wuhan		China	430014
138	Investigational Site Number :1560020	Xi'An		China	710061
139	Investigational Site Number :1560054	Xuzhou		China	221002
140	Investigational Site Number :1560011	Yangzhou		China	225001
141	Investigational Site Number :1560047	Yinchuan		China	750004
142	Investigational Site Number :1560031	Zhanjiang		China	524001
143	Investigational Site Number :1560002	Zhengzhou		China	450003
144	Investigational Site Number :2030002	Jindrichuv Hradec III		Czechia	37701
145	Investigational Site Number :2030005	Karlovy Vary		Czechia	36017
146	Investigational Site Number :2030009	Miroslav		Czechia	67172
147	Investigational Site Number :2030001	Novy Bor		Czechia	47301
148	Investigational Site Number :2030003	Praha 4		Czechia	14059
149	Investigational Site Number :2030008	Praha 6 - Brevnov		Czechia	16900
150	Investigational Site Number :2030004	Rokycany		Czechia	33722
151	Investigational Site Number :2030006	Strakonice		Czechia	38601
152	Investigational Site Number :2080001	Copenhagen Nv		Denmark	2400
153	Investigational Site Number :2080008	Hellerup		Denmark	2900
154	Investigational Site Number :2080002	Hvidovre		Denmark	2650
155	Investigational Site Number :2080006	Naestved		Denmark	4700
156	Investigational Site Number :2080005	Odense C		Denmark	5000
157	Investigational Site Number :2080004	Roskilde		Denmark	4000
158	Investigational Site Number :2080007	Vejle		Denmark	7100
159	Investigational Site Number :2080003	Ålborg		Denmark	9100
160	Investigational Site Number :2460003	Pori		Finland	28500
161	Investigational Site Number :2460002	Tampere		Finland	33520
162	Investigational Site Number :2460001	Turku		Finland	20520
163	Investigational Site Number :2760006	Berlin		Germany	10787
164	Investigational Site Number :2760009	Frankfurt am Main		Germany	60596
165	Investigational Site Number :2760002	Hamburg		Germany	20354
166	Investigational Site Number :2760007	Koblenz		Germany	56068
167	Investigational Site Number :2760011	Leipzig		Germany	04347
168	Investigational Site Number :2760010	Lübeck		Germany	23552
169	Investigational Site Number :2760008	Marburg		Germany	35043
170	Investigational Site Number :3480007	Balassagyarmat		Hungary	2660
171	Investigational Site Number :3480011	Budapest		Hungary	1122
172	Investigational Site Number :3480008	Edelény		Hungary	3780
173	Investigational Site Number :3480001	Gödöllö		Hungary	2100
174	Investigational Site Number :3480010	Hajdunánás		Hungary	4080
175	Investigational Site Number :3480002	Komarom		Hungary	2900
176	Investigational Site Number :3480003	Makó		Hungary	6900
177	Investigational Site Number :3480006	Mohács		Hungary	7700
178	Investigational Site Number :3480012	Püspökladány		Hungary	4150
179	Investigational Site Number :3480005	Szombathely		Hungary	9700
180	Investigational Site Number :3480004	Százhalombatta		Hungary	2440
181	Investigational Site Number :3760006	Ashkelon		Israel	78278
182	Investigational Site Number :3760007	Beer Sheva		Israel	84101
183	Investigational Site Number :3760003	Haifa		Israel	34362
184	Investigational Site Number :3760005	Jerusalem		Israel	91031
185	Investigational Site Number :3760004	Jerusalem		Israel	91120
186	Investigational Site Number :3760001	Petah-Tikva		Israel	49100
187	Investigational Site Number :3760002	Rehovot		Israel	76100
188	Investigational Site Number :3800004	Cona	Ferrara	Italy	44124
189	Investigational Site Number :3800003	Rozzano	Milano	Italy	20089
190	Investigational Site Number :3800006	Bologna		Italy	40138
191	Investigational Site Number :3800002	Catania		Italy	95123
192	Investigational Site Number :3800007	Pisa		Italy	56124
193	Investigational Site Number :3800001	Reggio Emilia		Italy	42123
194	Investigational Site Number :3800005	Roma		Italy	00133
195	Investigational Site Number :3920013	Kasuga-shi	Fukuoka	Japan	816-0813
196	Investigational Site Number :3920011	Himeji-shi	Hyogo	Japan	670-0849
197	Investigational Site Number :3920023	Higashiibaraki-gun	Ibaraki	Japan	311-3193
198	Investigational Site Number :3920014	Naka-gun	Ibaraki	Japan	319-1113
199	Investigational Site Number :3920019	Takamatsu-shi	Kagawa	Japan	761-8073
200	Investigational Site Number :3920027	Yokohama-shi	Kanagawa	Japan	223-0059
201	Investigational Site Number :3920003	Joyo-shi	Kyoto	Japan	610-0113
202	Investigational Site Number :3920017	Kyoto-shi	Kyoto	Japan	612-8555
203	Investigational Site Number :3920006	Ueda-shi	Nagano	Japan
204	Investigational Site Number :3920029	Urasoe-shi	Okinawa	Japan	901-2121
205	Investigational Site Number :3920018	Kawachinagano-shi	Osaka	Japan	586-8521
206	Investigational Site Number :3920001	Kishiwada-shi	Osaka	Japan	596-8501
207	Investigational Site Number :3920028	Osaka-shi	Osaka	Japan	531-0073
208	Investigational Site Number :3920012	Sakai-shi	Osaka	Japan	591-8555
209	Investigational Site Number :3920021	Hamamatsu-shi	Shizuoka	Japan	434-8511
210	Investigational Site Number :3920008	Chuo-ku	Tokyo	Japan	103-0022
211	Investigational Site Number :3920030	Chuo-ku	Tokyo	Japan	103-0028
212	Investigational Site Number :3920005	Chuo-ku	Tokyo	Japan	104-0031
213	Investigational Site Number :3920015	Kokubunji-shi	Tokyo	Japan	185-0014
214	Investigational Site Number :3920016	Shinagawa-ku	Tokyo	Japan	140-8522
215	Investigational Site Number :3920004	Toshima-ku	Tokyo	Japan	170-0003
216	Investigational Site Number :3920026	Toshima-ku	Tokyo	Japan	1710014
217	Investigational Site Number :4100003	Wonju	Gangwon-do	Korea, Republic of	26426
218	Investigational Site Number :4100004	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620
219	Investigational Site Number :4100008	Incheon	Incheon-gwangyeoksi	Korea, Republic of	21431
220	Investigational Site Number :4100001	Seoul	Seoul-teukbyeolsi	Korea, Republic of	03080
221	Investigational Site Number :4100009	Seoul	Seoul-teukbyeolsi	Korea, Republic of	03312
222	Investigational Site Number :4100007	Seoul	Seoul-teukbyeolsi	Korea, Republic of	05505
223	Investigational Site Number :4840002	Guadalajara	Jalisco	Mexico	44100
224	Investigational Site Number :4840004	Chihuahua		Mexico	31000
225	Investigational Site Number :4840003	Durango		Mexico	34080
226	Investigational Site Number :4840006	Mexico Distrito Federal		Mexico	06700
227	Investigational Site Number :4840001	Monterrey		Mexico	64460
228	Investigational Site Number :4840007	Oaxaca		Mexico	68000
229	Investigational Site Number :4840005	Veracruz		Mexico	91910
230	Investigational Site Number :6160009	Grudziadz	Kujawsko-pomorskie	Poland	86-300
231	Investigational Site Number :6160007	Krakow	Malopolskie	Poland	31-559
232	Investigational Site Number :6160015	Grodzisk Mazowiecki	Mazowieckie	Poland	05-825
233	Investigational Site Number :6160012	Warszawa	Mazowieckie	Poland	01-456
234	Investigational Site Number :6160008	Bialystok	Podlaskie	Poland	15-044
235	Investigational Site Number :6160014	Elblag	Pomorskie	Poland	82-300
236	Investigational Site Number :6160011	Katowice	Slaskie	Poland	40-648
237	Investigational Site Number :6160016	Poznan	Wielkopolskie	Poland	60-214
238	Investigational Site Number :6160006	Poznan	Wielkopolskie	Poland	61-578
239	Investigational Site Number :6420001	Bucharest		Romania	011461
240	Investigational Site Number :6420009	Bucuresti		Romania	030303
241	Investigational Site Number :6420008	Bucuresti		Romania	050159
242	Investigational Site Number :6420003	Cluj-Napoca		Romania	400371
243	Investigational Site Number :6420004	Cluj-Napoca		Romania	400371
244	Investigational Site Number :6420007	Constanta		Romania	900002
245	Investigational Site Number :6420006	Timisoara		Romania	300310
246	Investigational Site Number :6420010	Timisoara		Romania	300310
247	Investigational Site Number :6430003	Chelyabinsk		Russian Federation	454091
248	Investigational Site Number :6430004	Kazan		Russian Federation	420008
249	Investigational Site Number :6430006	Moscow		Russian Federation	105077
250	Investigational Site Number :6430001	Moscow		Russian Federation	115093
251	Investigational Site Number :6430005	Moscow		Russian Federation	115280
252	Investigational Site Number :6430008	Moscow		Russian Federation	115682
253	Investigational Site Number :6430002	Moscow		Russian Federation	117546
254	Investigational Site Number :6430009	Moscow		Russian Federation	125284
255	Investigational Site Number :6430007	St-Petersburg		Russian Federation	193231
256	Investigational Site Number :7030007	Banska Bystrica		Slovakia	97517
257	Investigational Site Number :7030006	Humenne		Slovakia	066 01
258	Investigational Site Number :7030003	Levice		Slovakia	93401
259	Investigational Site Number :7030001	Poprad		Slovakia	058 01
260	Investigational Site Number :7030002	Spisska Nova Ves		Slovakia	05201
261	Investigational Site Number :7240096	Santiago de Compostela	A Coruña [La Coruña]	Spain	15706
262	Investigational Site Number :7240002	Barcelona	Barcelona [Barcelona]	Spain	08035
263	Investigational Site Number :7240007	Sant Boi de Llobregat	Barcelona [Barcelona]	Spain	08830
264	Investigational Site Number :7240005	Mérida / Badajoz	Extremadura	Spain	06800
265	Investigational Site Number :7240006	Pozuelo de Alarcón	Madrid	Spain	28223
266	Investigational Site Number :7240003	Madrid		Spain	28007
267	Investigational Site Number :7240001	Málaga		Spain	29010
268	Investigational Site Number :7240010	Palma de Mallorca		Spain	07120
269	Investigational Site Number :7240004	Valencia		Spain	46015
270	Investigational Site Number :7520001	Lund		Sweden	221 85
271	Investigational Site Number :7520002	Stockholm		Sweden	114 46
272	Investigational Site Number :7520003	Örebro		Sweden	701 85
273	Investigational Site Number :7920004	Ankara		Turkey	06100
274	Investigational Site Number :7920001	Istanbul		Turkey	34098
275	Investigational Site Number :7920006	Izmir		Turkey	35040
276	Investigational Site Number :7920007	Izmir		Turkey	35110
277	Investigational Site Number :7920008	Kirikkale		Turkey	71450
278	Investigational Site Number :7920005	Manisa		Turkey	45000
279	Investigational Site Number :7920002	Mersin		Turkey	33070
280	Investigational Site Number :8040003	Chernivtsi		Ukraine	58001
281	Investigational Site Number :8040001	Ivano-Frankivsk		Ukraine	76018
282	Investigational Site Number :8040006	Kharkiv		Ukraine	61166
283	Investigational Site Number :8040004	Kyiv		Ukraine	02125
284	Investigational Site Number :8040009	Odesa		Ukraine	65025
285	Investigational Site Number :8040002	Ternopil		Ukraine	46000
286	Investigational Site Number :8040005	Vinnytsya		Ukraine	21001
287	Investigational Site Number :8040007	Zhytomyr		Ukraine	10002

Sponsors and Collaborators

• Sanofi
• Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT03930732
• Other Study ID Numbers: EFC15804; 2018-001953-28; U1111-1211-8804
• First Posted: Apr 29, 2019
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammation; Cholinergic Agents; Muscarinic Antagonists

Study Results

No Results Posted as of May 12, 2022