Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 21.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Verona Pharma PLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) and in this protocol. 2. Patient must be 40 to 80 years of age inclusive, at the time of Screening. 3. Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance (Section 11.8) 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: a) Not a woman of childbearing potential (WOCBP) as defined in the protocol Or b) A WOCBP who agrees to follow the contraceptive guidance in Section 11.8 of the protocol from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication. 4. 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. 5. 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. 6. COPD Symptoms: A score of =2 on the Modified Medical Research Council (mMRC) Dyspnea Scale. 7. COPD Severity: a. Pre- and Post-albuterol/salbutamol FEV1/FVC ratio of =65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: 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, sleep apnea, known alpha-1 antitrypsin deficiency, core pulmonale, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of ensifentrine on lung function compared to placebo over a 12-hour dosing interval in patients with moderate to severe chronic obstructive pulmonary disease (COPD).;Secondary Objective: ? To evaluate the effect of ensifentrine on other lung function parameters. ? To evaluate the effect of ensifentrine on COPD symptoms. ? To evaluate the effect of ensifentrine on health-related quality of life.;Primary end point(s): Average forced expiratory volume in 1 second (FEV1) ara under the curve (AUC)0-12h post-dose at Week 12 (change from baseline);Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Peak FEV1 over 4 hours post-dose at Week 12 (change from baseline). • Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 24 (change from baseline as a weekly average). • SGRQ total score at Week 24 (change from baseline). • Morning trough FEV1 at Week 12 (change from baseline). • Average FEV1 AUC0-4h post-dose at Week 12 (change from baseline). • The proportion of St. George’s Respiratory Questionnaire (SGRQ) responders at Week 24. • Rescue medication use at Week 24 (change from baseline). • Transitional Dyspnea Index (TDI) at Week 24. • Evening trough FEV1 at Week 12 (change from baseline). • Peak FEV1, morning and evening trough FEV1, FEV1 AUC0-4h, E-RS Total Score, SGRQ responder analysis, and TDI at other Study Visits (change from baseline). • SGRQ total score at Weeks 6 and 12 (change from baseline). • Rescue medication use at Weeks 6 and 12 (change from baseline).;Timepoint(s) of evaluation of this end point: as specified above | — |
Countries
Belgium, Bulgaria, Canada, Denmark, Estonia, Hungary, Poland, Slovakia, Spain, United States
Contacts
Public ContactInformation Desk
Verona Pharma PLC
Outcome results
None listed