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

Sponsor
Verona Pharma plc (Industry)
Overall Status
Completed
CT.gov ID
NCT04542057
Collaborator
Iqvia Pty Ltd (Industry)
808
Enrollment
141
Locations
2
Arms
21.4
Actual Duration (Months)
5.7
Patients Per Site
0.3
Patients Per Site Per Month

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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
808 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 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Actual Study Start Date :
Sep 22, 2020
Actual Primary Completion Date :
May 3, 2022
Actual Study Completion Date :
Jul 6, 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 24-week study that will enroll 800 patients and be randomized 5:3 to ensifentrine (3 mg): placebo
Placebo Comparator: Arm 2

Placebo Nebulized BID

Drug: Placebo
Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily 24-week study that will enroll 800 patients and be randomized 5:3 to 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 of Peak FEV1 over 4 hours post-dose at Week 12

  3. 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) responders at Week 24 [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 or 24 weeks]

    Change from baseline Peak FEV1

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

    Change from baseline morning trough FEV1

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

    Change from baseline evening trough FEV1

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

    Change from baseline FEV1 AUC0-4h

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

    Change from baseline E-RS Total Score

  15. SGRQ responder analysis at Week 6 and Week 12 [6 or 12 weeks]

    Change from baseline SGRQ responder analysis

  16. TDI at Week 6 and Week 12 [6 or 12 weeks]

    Change from baseline TDI

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

    Change from baseline of SGRQ total score

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

    Change from baseline of Rescue medication use

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). 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 (Celli BR, 2004) 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.

Randomization Criteria Criteria for Inclusion at Randomization

  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.

  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 trial 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 trial 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.

Criteria for Exclusion from Randomization

  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.

  5. 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 Wright Clinical Research, LLC Alabaster Alabama United States 35007
2 SEC Clinical Research Andalusia Alabama United States 36420
3 Jasper Summit Research LLC Jasper Alabama United States 35501
4 Pulmonary Associates Clinical Trials Phoenix Arizona United States 85006
5 Elite Clinical Studies LLC Phoenix Arizona United States 85018
6 Clinical Research Institute of Arizona, LLC Sun City West Arizona United States 85375
7 Premier Medical Group Bakersfield California United States 93309
8 Antelope Valley Clinical Trials Lancaster California United States 93534
9 Downtown LA Research Center, Inc. Los Angeles California United States 90017
10 UCLA Medical Center Los Angeles California United States 90095
11 California Medical Research Associates Northridge California United States 91324
12 Center for Clinical Trials of Sacramento, Inc. Sacramento California United States 95823
13 Integrated Research Center San Diego California United States 92117
14 Institute of HealthCare Assessment, Inc. San Diego California United States 92120
15 Alpine Clinical Research Center Boulder Colorado United States 80301
16 Innovative Research of West Florida Clearwater Florida United States 33756
17 Clinical Research of West Florida, Inc. Clearwater Florida United States 33765
18 Omega Research Consultants DeBary Florida United States 32713
19 Accel Research Sites - DeLand Clinical Research Unit DeLand Florida United States 32720
20 Riverside Clinical Research Edgewater Florida United States 32132
21 Medical Research of Central Florida Leesburg Florida United States 34748
22 Axcess Medical Research Loxahatchee Groves Florida United States 13005
23 ProCare Clinical Research Miami Gardens Florida United States 33014
24 Research Institute of South Florida Miami Florida United States 33173
25 Advanced Medical Research Institute Miami Florida United States 33174
26 Clinical Trials of Florida. LLC Miami Florida United States 33186
27 South Medical Research Group, Inc. Miami Florida United States 33186
28 HMD Research, LLC Orlando Florida United States 32819
29 Florida Institute for Clinical Research Orlando Florida United States 32825
30 Coastal Pulmonary Critical Care Saint Petersburg Florida United States 33704
31 Pasadena Center for Medical Research, LLC Saint Petersburg Florida United States 33707
32 Sarasota Clinical Research Sarasota Florida United States 34239
33 Clinical Research of West Florida, Inc. Tampa Florida United States 33606
34 Clinical Research Trials of Florida, Inc. Tampa Florida United States 33607
35 Florida Pulmonary Research Institute, LLC Winter Park Florida United States 32789
36 Genesis Clin RES& Consulting Fall River Massachusetts United States 02723
37 Minnesota Lung Center Edina Minnesota United States 55435
38 Minnesota Lung Center Woodbury Minnesota United States 55125
39 Midwest Chest Consultants Saint Charles Missouri United States 63301
40 Montana Medical Research Inc. Missoula Montana United States 59808
41 CHEAR Center LLC Bronx New York United States 10455
42 Pulmonary Health Physicians, P.C. Liverpool New York United States 13088
43 Mid Hudson Medical Research New Windsor New York United States 12553
44 Carolina Clinical Research Charlotte North Carolina United States 28273
45 American Health Research Charlotte North Carolina United States 28277
46 Clinical Research of Gastonia Gastonia North Carolina United States 28054
47 PharmQuest LLC Greensboro North Carolina United States 27408
48 Monroe Biomedical Research Monroe North Carolina United States 28112
49 Clinical Research of Lake Norman Mooresville North Carolina United States 28117
50 Carolina Research Center, Inc. Shelby North Carolina United States 28150
51 Aventiv Research Inc. Columbus Ohio United States 43213
52 Remington Davis Clinical Research Columbus Ohio United States 43215
53 Aventiv Research Dublin Ohio United States 43106
54 OK Clinical Research, LLC Edmond Oklahoma United States 73034
55 Velocity Clinical Research, Medford (Crisor, LLC) Medford Oregon United States 97504
56 Safe Harbor Clinical Research East Providence Rhode Island United States 02914
57 VitaLink Research Anderson Anderson South Carolina United States 29621
58 Lowcountry Lung and Critical Care, P.A. Charleston South Carolina United States 29406
59 VitaLink Research Columbia Columbia South Carolina United States 29204
60 Piedmont Research Partners Fort Mill South Carolina United States 29707
61 VitaLink Research Gaffney Gaffney South Carolina United States 29340
62 VitaLink Research - Greenville Greenville South Carolina United States 29615
63 Clinical Research of Rock Hill Rock Hill South Carolina United States 29732
64 Spartanburg Medical Research Spartanburg South Carolina United States 29303
65 VitaLink Research Spartanburg Spartanburg South Carolina United States 29303
66 CU Pharmaceutical Research Union South Carolina United States 29379
67 MultiSpecialty Clinical Research, Inc. Johnson City Tennessee United States 37601
68 New Phase Research Development Knoxville Tennessee United States 37909
69 PnP Research Amarillo Texas United States 79106
70 TTS Research Boerne Texas United States 78006
71 Corsicana Medical Research, PLLC Corsicana Texas United States 75110
72 Houston Pulmonary and Sleep Allergy and Asthma Associates Cypress Texas United States 77429
73 Biopharma Informatic, Inc. Research Center Houston Texas United States 77084
74 Metroplex Pulmonary and Sleep Center McKinney Texas United States 75069
75 Diagnostics Research Group San Antonio Texas United States 78229
76 Element Research Group San Antonio Texas United States 78258
77 Sherman Clinical Research Sherman Texas United States 75092
78 DM Clinical Research Tomball Texas United States 77375
79 Crescent Health Clinical Weatherford Texas United States 76086
80 Manassas Clinical Research Center Manassas Virginia United States 20110
81 UZA Edegem Belgium 2650
82 C.H.R. de la Citadelle Liège Belgium 4000
83 AZ Sint-Maarten Mechelen Belgium 2800
84 Private Practice RESPISOM Namur Namur Belgium 5101
85 AZ Delta Roeselare Belgium 8800
86 MHAT 'Puls' AD Blagoevgrad Bulgaria 2700
87 Medical Centre "Asklepii", OOD Dupnitsa Bulgaria 2600
88 MHAT 'Dr. Stamen Iliev', AD Montana Bulgaria 3400
89 SHATPPD - Pazardzhik, EOOD Pazardzhik Bulgaria 4400
90 SHATPD Pernik Pernik Bulgaria 2305
91 Medical Center- Prolet Ltd Ruse Bulgaria 7000
92 SHATPPD-Ruse EOOD Ruse Bulgaria 7002
93 University First MHAT-Sofia, "St. Joan Krastitel" EAD Sofia Bulgaria 1142
94 SHATPPD - Sofia District EOOD Sofia Bulgaria 1202
95 Fifth MHAT - Sofia EAD Sofia Bulgaria 1233
96 NMTH "Tsar Boris III" Sofia Bulgaria 1233
97 MHAT "Lyulin", EAD Sofia Bulgaria 1336
98 DCC "Alexandrovska", EOOD Sofia Bulgaria 1431
99 Diagnostic Consultation Center CONVEX EOOD Sofia Bulgaria 1680
100 Medical Center "Nov Rehabilitatsionen Tsentar", EOOD Stara Zagora Bulgaria 6000
101 SHATPD - Troyan EOOD Troyan Bulgaria 5600
102 Medical Center "ResearchExpert", OOD Varna Bulgaria 9000
103 MC "Tara", OOD Veliko Tarnovo Bulgaria 5000
104 SHATPPD "Dr. Treyman" EOOD Veliko Tarnovo Bulgaria 5000
105 SHATPPD - Vratsa, EOOD Vratsa Bulgaria 3000
106 ALTA Clinical Research Inc. Edmonton Alberta Canada T5A 4L8
107 Synergy Respiratory Care Sherwood Park Alberta Canada T8H 0N2
108 Dynamic Drug Advancement Ajax Ontario Canada LIS 2J5
109 Respirology and Rheumatology Associates Windsor Ontario Canada N8X 1T3
110 C.I.C. Mauricie Inc. Trois-Rivières Quebec Canada G8T 7A1
111 Hvidovre Hospital Hvidovre Denmark 2650
112 Odense Universitetshospital Odense C Denmark 5000
113 Zealand University Hospital, Roskilde Roskilde Denmark 4000
114 North Estonia Medical Centre Foundation Tallinn Estonia 13419
115 Tartu University Hospital, Lung Clinic Tartu Estonia 50411
116 Dr. Kenessey Albert Kórház-Rendelőintézet, Pulmonológiai Osztály Balassagyarmat Hungary 2660
117 Komlói Egészségcentrum, Bányászati Utókezelő és Éjjeli Szanatórium Egészségügyi Központ Komló Hungary 7300
118 Da Vinci Klinika Infer-Med Kft. Tüdőgyógyászat Pécs Hungary 7634
119 Szarvasi Tüdőgyógyász Kft Szarvas Hungary 5540
120 Csanád-Csongrád Megyei Mellkasi Betegségek Szakkórháza, Tüdőgondozó Intézet Szeged Hungary 6722
121 Szent Borbála Kórház, Tüdőgyógyászat Tatabánya Hungary 2800
122 Centrum Medyczne All-Med Kraków Poland 30-033
123 Małopolskie Centrum Alergologii Kraków Poland 31-624
124 Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik Ostrowiec Świętokrzyski Poland 27-400
125 Prywatny Gabinet Lekarski Rzeszów Poland 35-051
126 Gabinet Pulmonologii i Diagnostyki Chorób Alergicznych Szczecin Poland 70-111
127 "Alergo-Med" Specjalistyczna Przychodnia Lekarska Sp. Z O. O. Tarnów Poland 33-100
128 Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska Wrocław Poland 51-162
129 "ALL-MED" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Wrocław Poland 53-201
130 ETG Łódź Łódź Poland 90-302
131 Pneumologicko-ftizeologická ambulancia, Pneumomed, s.r.o Bratislava Slovakia 851 01
132 Zeleznicna nemocnica s poliklinikou Košice Slovakia 04001
133 Ambulancia pneumologie a ftizeologie, ZAPA JJ, s.r.o. Levice Slovakia 93401
134 Univerzitna nemocnica Martin, Klinika pneumologie a ftizeologie Martin Slovakia 03659
135 PNEUMO-MED s.r.o. Prievidza Slovakia 97101
136 Hospital Vithas Internacional Xanit Benalmádena Málaga Spain 29631
137 Hospital Universitario Puerta del Mar Cadiz Spain 11009
138 Institut Catala de Serveis Medics Girona Spain 17005
139 Hospital Universitario Virgen de las Nieves Granada Spain 18014
140 Hospital Clinico Universitario Virgen de la Victoria Málaga Spain 29010
141 Hospital Clinico Universitario de Valencia Valencia Spain 45010

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:
NCT04542057
Other Study ID Numbers:
  • RPL554-CO-302
First Posted:
Sep 9, 2020
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Aug 16, 2022