A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD

• Sponsor: Verona Pharma plc (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04535986
• Collaborator: Iqvia Pty Ltd (Industry)
• Enrollment: 800
• Locations: 135
• Arms: 2
• Anticipated Duration (Months): 25.9
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if ensifentrine is safe and effective for the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Ensifentrine; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks (With a 48-week Safety Subset) in Subjects With Moderate to Severe COPD
• Actual Study Start Date: Sep 29, 2020
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Nov 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Ensifentrine Nebulized Suspension; 3 mg BID	Drug: Ensifentrine; • Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily Study to randomize 800 patients in total Subjects randomized to the 24-week subset will enroll 400 patients (1:1 ensifentrine (3 mg): placebo) Subjects randomized to the 48-week subset will enroll approximately 400 patients randomized 3:1 ensifentrine (3 mg): placebo.
Placebo Comparator: Arm 2 Placebo Nebulized BID	Drug: Placebo; • Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily Study to randomize 800 patients in total Subjects randomized to the 24-week subset will enroll 400 patients (1:1 ensifentrine (3 mg): placebo) Subjects randomized to the 48-week subset will enroll approximately 400 patients randomized 3:1 ensifentrine (3 mg): placebo.

Outcome Measures

Primary Outcome Measures

1. Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)0-12h [12 weeks]

   Change from baseline of Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)0-12h

Secondary Outcome Measures

1. Average FEV1 AUC0-4h post-dose at Week 12 [12 weeks]

   Change from baseline of Average FEV1 AUC0-4h post-dose at Week 12

2. Peak FEV1 over 4 hours post dose at Week 12 [12 weeks]

   Change from baseline in Peak FEV1 over 4 hours post dose at Week 12

3. Weekly average of Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 24 [24 weeks]

   Change from baseline as a weekly average of Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 24

4. St. George's Respiratory Questionnaire (SGRQ) total score at Week 24 [24 weeks]

   Change from baseline of SGRQ total score at Week 24

5. Morning trough FEV1 at Week 12 [12 weeks]

   Change from baseline of Morning trough FEV1 at Week 12

6. St. George's Respiratory Questionnaire (SGRQ) [24 weeks]

   The proportion of St. George's Respiratory Questionnaire (SGRQ) responders at Week 24.

7. Rescue medication use at Week 24 [24 weeks]

   Change from baseline of Rescue medication use at Week 24

8. Transitional Dyspnea Index (TDI) at Week 24 [24 weeks]

   Transitional Dyspnea Index (TDI) at Week 24

9. Evening trough FEV1 at Week 12 [12 weeks]

   Change from baseline Evening trough FEV1 at Week 12

10. Peak FEV1 at Week 6 and Week 24 [6 and 24 weeks]

    Change from baseline Peak FEV1

11. Morning trough FEV1 at Week 6 and Week 24 [6 and 24 weeks]

    Change from baseline morning trough FEV1

12. Evening trough FEV1 at Week 6 and Week 24 [6 and 24 weeks]

    Change from baseline evening trough FEV1

13. FEV1 AUC0-4h at Week 6 and Week 24 [6 and 24 weeks]

    Change from baseline FEV1 AUC0-4h

14. Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 6 and Week 12 [6 and 12 weeks]

    Change from baseline E-RS Total Score

15. St. George's Respiratory Questionnaire (SGRQ) responder analysis at Week 6 and Week 12 [6 and 12 weeks]

    Change from baseline SGRQ responder analysis

16. TDI at Week 6 and Week 12 [6 and 12 Weeks]

    Change from baseline TDI

17. St. George's Respiratory Questionnaire (SGRQ) total score at Weeks 6 and 12 [6 Weeks and 12 weeks]

    Change from baseline of SGRQ total score at Weeks 6 and 12

18. Rescue medication use at Weeks 6 and 12 [12 weeks]

    Change from baseline of Rescue medication use at Weeks 6 and 12

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Informed Consent

1. Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form (ICF).

Age and Sex

1. Age: Patient must be 40 to 80 years of age inclusive, at the time of Screening.

2. Sex:

• Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.

• Females are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions apply:

1. Not a woman of childbearing potential (WOCBP) as defined in Or

2. A WOCBP who agrees to follow the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.

Smoking History

1. Smoking History: Current or former cigarette smokers with a history of cigarette smoking ≥10 pack years at Screening (Visit 0) [number of pack years = (number of cigarettes per day / 20) × number of years smoked (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 0. Smoking cessation programs are permitted during the study.

COPD Diagnosis, Symptoms, Severity and Maintenance Therapy

1. COPD Diagnosis: Patients with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD.

2. COPD Symptoms: A score of ≥2 on the Modified Medical Research Council (mMRC) Dyspnea Scale.

3. COPD Severity:

4. Pre- and Post-albuterol/salbutamol FEV1/FVC ratio of <0.70.

5. Post-albuterol/salbutamol FEV1 ≥30 % and ≤70% of predicted normal calculated using the National Health and Nutrition Examination Survey III.

6. Maintenance Therapy: Patients on no maintenance/background therapy or patients on stable maintenance LAMA or LABA therapy are eligible. Patients taking maintenance LAMA or LABA therapy must demonstrate stable use of the maintenance LAMA or LABA therapy for at least 3 months prior to Screening and agree to continue use for the duration of the study. Background maintenance LAMA or LABA bronchodilator therapy will be capped at 50% of patients.

Other Requirements for Inclusion

1. Capable of withholding SABAs for 4 hours prior to initiation of any spirometry. Patients in the maintenance LAMA or LABA therapy stratum must be capable of withholding Twice-Daily maintenance LAMA or LABA for 24 hours and Once-Daily maintenance LAMA or LABA for 48 hours prior to initiation of any spirometry.

2. Capable of using the study nebulizer correctly and complying with all study restrictions and procedures.

3. Ability to perform acceptable spirometry in accordance with ATS/ERS guidelines.

Inclusion Criteria at Randomization (RPL554-CO-301)

1. Symptoms of COPD: A score of ≥2 on the mMRC Dyspnea Scale.

2. Completion of the e-Diary at least 5 of the last 7 days of the Run-in period.

Exclusion Criteria:

Current Condition or Medical History

1. History of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.

2. Hospitalizations for COPD, pneumonia, or Corona Virus Disease 2019 (COVID-19) in the 12 weeks prior to Screening and/or a positive COVID-19 test result indicating an active infection at Screening. Patients with COVID-19 antibodies from a previous exposure with no active infection are not excluded.

3. COPD exacerbation requiring oral or parenteral steroids within 3 months of Screening.

4. Previous lung resection or lung reduction surgery within 1-year of Screening.

5. Long term oxygen use defined as oxygen therapy prescribed for greater than 12 hours per day. As needed oxygen use (≤12 hours per day) is not exclusionary.

6. Pulmonary rehabilitation, unless such treatment has been in a stable maintenance phase for 4 weeks prior to Visit 1 and remains stable during the study.

7. Lower respiratory tract infection within 6 weeks of Screening.

8. Other respiratory disorders including, but not limited to, a current diagnosis of asthma, active tuberculosis, lung cancer, sarcoidosis, lung fibrosis, interstitial lung diseases, unstable sleep apnea, known alpha-1 antitrypsin deficiency, core pulmonale, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary diseases.

9. Major surgery (requiring general anesthesia) in the 6 weeks prior to Screening, lack of full recovery from surgery at Screening, or planned surgery through the end of the study.

10. Historical or current evidence of clinically significant cardiovascular disease defined as any disease that in the opinion of the Investigator would put the safety of the patient at risk through participation or which could affect the efficacy or safety analysis if the disease/condition were to exacerbate during the study, including, but not limited to:

• Myocardial infarction or unstable angina within 6 months prior to Screening.

• Unstable or life-threatening cardiac arrhythmia requiring intervention within 3 months prior to Screening.

• Diagnosis of New York Heart Association Class III and Class IV heart failure.

1. Chronic uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric, or ophthalmic diseases that the Investigator believes are clinically significant.

2. Unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).

3. History of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin.

4. Findings on physical examination that an investigator considers to be clinically significant at Screening.

Prior/Concomitant Therapy

1. Use of prohibited medications within the time intervals.

History or Suspicion of Drug or Alcohol Abuse

1. Current or history of past drug or alcohol abuse within the past 5 years.

Laboratory and Other Diagnostic Parameters

1. Glomerular Filtration Rate (eGFR) <30 mL/min. The Chronic Kidney Disease Epidemiology Collaboration Creatinine (2009) calculation will be used (Levey, 2009).

2. Alanine aminotransferase (ALT) ≥ 2 x upper limit of normal (ULN), alkaline phosphatase and/or bilirubin > 1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

3. Hepatitis B antibody:

• Positive findings for both Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (anti-HBc) are excluded, as this indicates acute or chronic infection.

• Negative findings for HBsAg and Hepatitis B surface antibody (anti-HBs) but positive findings for anti-HBc are excluded as this may indicate current or resolving infection.

• Positive findings for anti-HBc and anti-HBs but negative findings for HBsAg are not excluded, as this indicates immunity due to natural infection.

• Positive findings for anti-HBs but negative findings for HBsAg and anti-HBc are not excluded, as this indicates immunity due to hepatitis B vaccination.

1. Hepatitis C antibody positive.

2. Any other abnormal hematology, biochemistry, or viral serology deemed by an investigator to be clinically significantly abnormal. Abnormal chemistry and/or hematology may be repeated during Screening.

3. Chest X-ray (CXR; posterior-anterior) at Screening, or in the 12 months prior to Screening with clinically significant abnormalities not attributable to COPD. If a CXR within the past 12 months is not available but a computerized tomography (CT) scan within the same time period is available, the CT scan may be reviewed in place of a CXR. For subjects in Germany, if a CXR or CT scan is not available in the 12 months prior to Screening, the subject is not eligible for the study.

4. Electrocardiogram (ECG) finding that is significantly abnormal on the 12-lead ECG obtained at Screening.

Other Exclusions

1. Use of an experimental drug within 30 days or 5 half-lives of Screening, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical study within 30 days prior to Screening.

2. Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical study within 30 days prior to Screening.

3. Intolerance or hypersensitivity to albuterol/salbutamol or ensifentrine (RPL554) or any of its excipients/components.

4. Prior receipt of blinded study medication in an ensifentrine (RPL554) study.

5. Affiliation with the investigator site, including an Investigator, Sub-Investigator, study coordinator, study nurse, other employee of participating investigator or study site or a family member of the aforementioned.

6. Inability to read, understand, and/or complete questionnaires (in the opinion of the Investigator).

7. A disclosed history or one known to the Investigator of significant non-compliance in previous investigational studies or with prescribed medications.

8. Any other reason that the Investigator considers makes the patient unsuitable to participate.

Exclusion Criteria at Randomization (RPL554-CO-301)

1. COPD exacerbation or lower respiratory tract infection between Screening and Randomization (defined as use of any additional treatment other than current treatment and rescue medication and/or emergency department or hospital visit). Patients with a severe COPD exacerbation that requires hospitalization may not be rescreened.

2. Positive COVID-19 result at Screening or between Screening and Randomization.

3. Prohibited medication use between Screening Visit 0 and Visit 1.

4. Significantly abnormal ECG finding on the 12-lead ECG obtained at Screening as assessed by the investigator or site medical doctor/medically qualified person or on the pre-dose (prior to randomization) ECG obtained at Visit 1.

In the event that the central ECG reviewer discovers a significant ECG abnormality on the Visit 1 ECG, the patient will be discontinued.

1. Did not meet one or more of the Inclusion Criteria or met one or more of the Exclusion Criteria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Medical Group	Peoria	Arizona	United States	85381
2	AMR Tempe	Tempe	Arizona	United States	85281
3	Beach Physicians Medical Group	Huntington Beach	California	United States	92647
4	Downtown LA Research Center, Inc.	Los Angeles	California	United States	90017
5	Clinical Research of West Florida, Inc.	Clearwater	Florida	United States	33765
6	St. Francis Medical Institute	Clearwater	Florida	United States	33765
7	Qway Research, LLC	Hialeah	Florida	United States	33010
8	Multi-Specialty Research Associates, Inc.	Lake City	Florida	United States	32055
9	Elite Clinical Research	Miami	Florida	United States	33144
10	Global Research Solutions Corp	Miami	Florida	United States	33144
11	Phoenix Medical Research	Miami	Florida	United States	33165
12	Florida Institute for Clinical Research	Orlando	Florida	United States	32825
13	Precision Clinical Research	Sunrise	Florida	United States	33351
14	Clinical Research of West Florida, Inc.	Tampa	Florida	United States	33606
15	iResearch Atlanta, LLC	Decatur	Georgia	United States	30030
16	In-Quest Medical Research, LLC	Peachtree Corners	Georgia	United States	30071
17	IACT Health	Rincon	Georgia	United States	31326
18	John Hopkins University School of Medicine	Baltimore	Maryland	United States	21224
19	Pulmonary Research Institute of SE Michigan	Farmington Hills	Michigan	United States	48336
20	Midwest Chest Consultants	Saint Charles	Missouri	United States	63301
21	The Clinical Research Center, LLC	Saint Louis	Missouri	United States	63141
22	Sierra Clinical Research	Las Vegas	Nevada	United States	89106
23	Alliance for Multispecialty Research, LLC	Las Vegas	Nevada	United States	89119
24	IMA Clinical Research, LLC	New York	New York	United States	10036
25	Monroe Biomedical Research	Monroe	North Carolina	United States	28112
26	Remington Davis Clinical Research	Columbus	Ohio	United States	43215
27	Crisor, LLC - Grants Pass	Grants Pass	Oregon	United States	97527
28	Clinical Research Associates of Central PA, LLC	DuBois	Pennsylvania	United States	15801
29	University of Pittsburgh Physicians, Emphysema/COPD Research Center	Pittsburgh	Pennsylvania	United States	15213
30	Safe Harbor Clinical Research	North Smithfield	Rhode Island	United States	02896
31	Medtrial	Columbia	South Carolina	United States	29204
32	MDFirst Research	Lancaster	South Carolina	United States	29720
33	Chattanooga Research & Medicine (CHARM)	Chattanooga	Tennessee	United States	37404
34	MultiSpecialty Clinical Research, Inc.	Johnson City	Tennessee	United States	37601
35	New Phase Research Development	Knoxville	Tennessee	United States	37909
36	West Houston Clinical Research Services	Houston	Texas	United States	77055
37	LinQ Research, LLC	Pearland	Texas	United States	77584
38	Sherman Clinical Research	Sherman	Texas	United States	75092
39	Pulmonary Research of Abingdon, LLC	Abingdon	Virginia	United States	24210
40	TPMG Clinical Research Williamsburg	Williamsburg	Virginia	United States	23188
41	SHATPPD - Haskovo, EOOD	Haskovo		Bulgaria	6300
42	Medical center Medconsult Pleven OOD	Pleven		Bulgaria	5800
43	UMHAT-Plovdiv AD	Plovdiv		Bulgaria	4003
44	Medical Center Hera EOOD	Sofia		Bulgaria	1510
45	MC "Sv. Ivan Rilski", OOD	Vidin		Bulgaria	3700
46	MUDr. I. Cierna Peterova s.r.o.	Brandýs Nad Labem		Czechia	25001
47	Fakultni nemocnice Brno, Dept of Klinika nemoci plicnich a tuberkulozy	Brno		Czechia	625 00
48	EDUMED s.r.o.	Broumov		Czechia	550 01
49	MUDr. Petr Pravda	Hlučín		Czechia	74801
50	MediTrial s.r.o.	Jindřichův Hradec		Czechia	377 01
51	Plicni ambulance Kralupy s.r.o.	Kralupy Nad Vltavou		Czechia	278 01
52	CEFISPIRO s.r.o.	Lovosice		Czechia	41002
53	Odborná plicní ambulance Opava s.r.o.	Opava		Czechia	74601
54	DAWON spol. s.r.o., Plicni ambulance	Praha 4		Czechia	149 00
55	Plicni centrum s.r.o.	Praha 5		Czechia	15300
56	MUDr. Josef Veverka, Plicni ambulacne	Rokycany		Czechia	33701
57	Plicni stredisko Teplice s.r.o.	Teplice		Czechia	41501
58	Nemocnice Trebic p.o., Dept of Plicni ambulance	Třebíč		Czechia	674 01
59	Praxis Dr. Junggeburth	Bad Wörishofen	Bayern	Germany	86825
60	MECS GmbH Cottbus	Cottbus	Brandenburg	Germany	03050
61	Clinical Studies Pankow Dr Dr Evelin Liefring/Ishak Teber	Berlin	Bremen	Germany	13187
62	IKF Pneumologie GmbH & Co. KG	Frankfurt am Main	Hessen	Germany	60596
63	Praxis Dr. Keller	Frankfurt	Hessen	Germany	60389
64	Dr. Christian Schlenska	Peine	Niedersachsen	Germany	31224
65	Zentrum fur Klinische Forschung	Koeln	Nordrhein Westfalen	Germany	51069
66	Framol-med GmbH, Pneumologische Gemeinschaftspraxis Rheine	Rheine	Nordrhein Westfalen	Germany	48431
67	SMO.MD GmbH	Magdeburg	Sachsen Anhalt	Germany	39120
68	Pneumologische Praxis Dr. Falk Brunner	Leipzig	Sachsen	Germany	04157
69	Salvus-Klinische Studien GmbH.	Leipzig	Sachsen	Germany	04207
70	POIS Leipzig GbR, Pneumo-/onkologisch/internistisches Studienzentrum	Leipzig	Sachsen	Germany	04357
71	PRI Pulmonary Research Institute, Pneumologisches Forschungsinstitut GmbH	Großhansdorf	Schleswig Holstein	Germany	22927
72	KLB Gesundheitsforschung Luebeck GmbH; Praxis Dr. med. Jens Becker	Luebeck	Schleswig Holstein	Germany	23552
73	Studienpraxis Berlin-Brandenburg	Berlin		Germany	10119
74	Praxis an der Oper.	Berlin		Germany	10625
75	Ballenberger, Freytag, Wenisch Institut für klinische Forschung	Neu Isenburg		Germany	63263
76	General Hospital of Athens Laiko	Athens		Greece	11527
77	General Hospital of Athens of Chest Diseases "SOTIRIA", 7th Respiratory Clinic	Athens		Greece	11527
78	University General Hospital of Heraklion, Pulmonary Clinic	Heraklion		Greece	71110
79	University General Hospital of Ioannina, University Respiratory Clinic	Ioánnina		Greece	45500
80	University General Hospital of Larissa, University Pulmonary Clinic	Larissa		Greece	41110
81	Clinexpert Kft.	Budapest		Hungary	1033
82	Szalay János Rendelőintézet Tüdőgyógyászati Szakrendelés	Hajdúnánás		Hungary	4080
83	Lumniczer Sandor Kórház és Rendelőintézet Tüdőgondozó	Kapuvár		Hungary	9330
84	Bajcsy-Zsilinszky Kórház és Rendelőintézet Monori Rendelőintézete	Monor		Hungary	2200
85	Karolina Kórház-Rendelőintézet, Tüdőgyógyászat	Mosonmagyaróvár		Hungary	9200
86	Püspökladányi Egészségügyi Szolgáltató Nonprofit Kft.	Püspökladány		Hungary	4150
87	Markusovszky Egyetemi Oktatókórház Tüdőgondozó	Szombathely		Hungary	9700
88	Yonsei University Wonju Severance Christian Hospital	Wŏnju	Gangwon-do	Korea, Republic of	26426
89	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620
90	Yeungnam University Hospital	Daegu		Korea, Republic of	42415
91	Kyung Hee University Hospital	Seoul		Korea, Republic of	02447
92	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
93	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
94	Asan Medical Center	Seoul		Korea, Republic of	05505
95	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
96	The Catholic University of Korea, Yeouido St.Mary's Hospital	Seoul		Korea, Republic of	07345
97	NZOZ Centrum Medyczne KERmed	Bydgoszcz		Poland	85-231
98	Uniwersyteckie Centrum Kliniczne	Gdańsk		Poland	80-214
99	NZOZ Alergopneuma Sp. J. Marek Michnar I Wspólnicy	Lublin		Poland	20-089
100	Centrum Alergologii Sp. z o. o.	Lublin		Poland	20-552
101	Centrum Medyczne Grunwald	Poznań		Poland	60-369
102	ETG Siedlce	Siedlce		Poland	08-110
103	NASZ LEKARZ Ośrodek Badań Klinicznych	Toruń		Poland	87-100
104	ETG Warszawa	Warsaw		Poland	02-793
105	S.C Centrul Medical Unirea S.R.L, Campus Medical Brasov	Braşov		Romania	500091
106	S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L	Braşov		Romania	500283
107	Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca	Braşov		Romania	500366
108	Quantum Medical Center S.R.L.	Bucuresti		Romania	012071
109	Institutul de Pneumoftiziologie "Marius Nasta"	Bucuresti		Romania	050159
110	S.C Cardiomed S.R.L	Cluj-Napoca		Romania	400371
111	Cabinet Pneumologie Dr. Bogdan Mincu	Cluj-Napoca		Romania	400379
112	Impatiens SRL	Codlea		Romania	505100
113	Fundatia Cardioprevent	Timişoara		Romania	300134
114	Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara	Timişoara		Romania	300310
115	NSHI "Departmental CH on St. Barnaul of JSCO "Russian Railways"	Barnaul		Russian Federation	656038
116	SBHI "Regional Clinical Hospital #3"	Chelyabinsk		Russian Federation	454091
117	LLC MA New Hospital	Ekaterinburg		Russian Federation	620109
118	City Hospital #6	Ekaterinburg		Russian Federation	620149
119	FSBI "Scientific-research Institute for Complex Problems of cardiovascular disease"	Kemerovo		Russian Federation	650002
120	LLC "Novosibirsk GastroCenter"	Novosibirsk		Russian Federation	630007
121	SBIH of Novosibirsk Region "Clinical Emergency Hospital #2"	Novosibirsk		Russian Federation	630008
122	City Clinical Hospital #25	Novosibirsk		Russian Federation	630075
123	SPb SBHI "Vvedenskaya hospital"	Saint Petersburg		Russian Federation	191180
124	"LEC at the LLC "LLC "Energiy Zdorovya"	Saint Petersburg		Russian Federation	194156
125	LLC "Institute of Medical Examinations"	Saint Petersburg		Russian Federation	196084
126	Research center Eco-safety, LLC	Saint Petersburg		Russian Federation	196143
127	Pavlov First Saint Petersburg State Medical University	Saint Petersburg		Russian Federation	197022
128	SPb SBIH "City Hospital # 40 of Kurortnyi region"	Sestroretsk		Russian Federation	197706
129	SBHI of Yaroslavl Region "Clinical Hospital # 2"	Yaroslavl		Russian Federation	1500030
130	SBHI of Yaroslavl Region "Clinical Hospital # 2"	Yaroslavl		Russian Federation	150010
131	SBHI Outpatient 2	Yaroslavl		Russian Federation	150047
132	Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov	Bardejov		Slovakia	08501
133	Inspiro, s.r.o.	Humenné		Slovakia	06601
134	Plucna ambulancia Hrebenar, s.r.o.	Spišská Nová Ves		Slovakia	05201
135	Respiratory Clinical Trials Ltd	London	Greater London	United Kingdom	W1T6AH

Sponsors and Collaborators

• Verona Pharma plc
• Iqvia Pty Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Verona Pharma plc
• ClinicalTrials.gov Identifier: NCT04535986
• Other Study ID Numbers: RPL554-CO-301
• First Posted: Sep 2, 2020
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Verona Pharma plc: COPD
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jul 12, 2022