Do you suffer from chronic obstructive pulmonary disease (COPD)?
This clinical research study is looking at the safety and effectiveness of an experimental medication for people with COPD. COPD is a lung condition associated with blockage of the airways due to mucus accumulation and swelling, and/or damage to tiny air sacks in the lungs. This makes it very hard to breathe, affecting one’s overall quality of life. This particular study is looking for volunteers who are current or former smokers.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow up of your COPD to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others with COPD, and whether it will be made widely available to all Canadians with COPD. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are 40 to 85 years of age inclusive.
- Are a current or former cigarette smoker with a history of smoking greater than or equal to 10 pack years. If you wish to calculate your pack-years, please use this website: https://www.smokingpackyears.com/
- For former smokers: participants who report that they are not currently smoking, smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.
- For current smokers: participants who report that they are currently smoking tobacco (participant smoked at least 1 cigarette per day on average during the past 7 days) at Screening (Visit 1A) and who are not currently participating in or planning to initiate a smoking cessation intervention at Screening (Visit 1A) or during Screening period.
- Have a physician diagnosis of COPD for at least 1 year
- Have participant-reported history of signs and symptoms of chronic bronchitis
- Have a documented history of high exacerbation risk defined as having had ≥2 moderate or ≥1 severe exacerbations within the year prior to Screening (Visit 1A), with at least 1 exacerbation treated with systemic corticosteroids. At least one exacerbation must have occurred while participants were on their current controller therapy.
- Have had standard of care controller therapy, for ≥3 months prior to Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month prior to the Screening, including either: inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA) + LABA or LAMA + LABA + ICS.
- Have a body mass index (BMI) ≥18.0 kg/m^2
- If female, participant is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- not a women of child-bearing potential (WOCBP) OR
- a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention
You may not qualify to participate if you:
- Have a current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma unless asthma resolved before 18 years of age and has not recurred.
- For former smokers: Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [THC]) within 6 months prior to Screening
- For current smokers: vaping of any products (eg, nicotine, THC) within 6 months prior to Screening
- Have a clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening (Visit 1A).
- Have any clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of α-1 anti-trypsin deficiency, or another diagnosed pulmonary disease.
- Have a diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension.
- Have hypercapnia requiring bilevel positive airway pressure (BiPAP).
- Have a moderate or severe exacerbation of COPD (AECOPD) within 4 weeks prior to Screening (Visit 1A).
- Have any prior history of / planned: lung pneumonectomy for any reason, or lung volume reduction procedures (including bronchoscopic volume reduction) for COPD. Note: Surgical biopsy, or segmentectomy, or wedge resection, or lobectomy for other diseases would not be excluded.
- Have unstable ischemic heart disease, including acute myocardial infarction within the past 1 year prior to Screening, or unstable angina in the 6 months prior to Screening (Visit 1A).
- Have cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation.
- Have uncontrolled hypertension (ie, systolic blood pressure [BP] >180 mm Hg or diastolic BP >110 mm Hg with or without use of anti-hypertensive therapy).
- Have active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI), or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A).
- Have a history of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening (Visit 1A).
- Have any suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or in contact with known exposure to COVID-19 at Screening (Visit 1A); known history of COVID-19 infection within 4 weeks prior to Screening (Visit 1A); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening (Visit 1A); participants who have had a COVID-19 infection prior Screening (Visit 1A) who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
- Have any evidence of acute or chronic infection requiring systemic treatment with antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 4 weeks before Screening (Visit 1A), significant viral infections within 4 weeks before Screening (Visit 1A) that may not have been treated with antiviral treatment (eg, influenza receiving only symptomatic treatment).
- Have active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis.
- Have any history of malignancy within 5 years before Screening (Visit 1A), except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.