A Study to Test a Potential New Treatment for COPD Patients Suffering From the Common Cold or Inf⦠(NCT03570359) | Clinical Trial Compass
CompletedPhase 2
A Study to Test a Potential New Treatment for COPD Patients Suffering From the Common Cold or Influenza
United Kingdom122 participantsStarted 2018-01-29
Plain-language summary
The aim of the study is to assess the safety of inhaled SNG001 and the ability of inhaled SNG001 to 'switch on' the cells' anti-viral defences in patients with chronic obstructive pulmonary disease (COPD). The study consist of two parts.
Part 1 will assess the safety of inhaled SNG001 in ten patients with stable COPD.
Part 2 will assess efficacy and safety of inhaled SNG001 in 120 patients with COPD with a cold or COPD exacerbation.
Who can participate
Age range40 Years β 85 Years
SexALL
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Inclusion criteria
β. Male or female, between and including 40-75 years of age, at the time of the screening visit.
β. A confirmed physician diagnosis of COPD or a medical history consistent with a diagnosis of COPD for at least 12 months prior to the screening visit.
β. Post-bronchodilator FEV1 β₯40% of predicted and FEV1/FVC ratio \<0.7 (at screening).
β. FEV1 β₯30% of predicted (at Visit 2, pre-dose).
β. Should have stable COPD, having no symptoms of an exacerbation and/or respiratory tract infection currently and/or within the past 6 weeks of screening and/or randomisation.
β. Should be prescribed and taking regularly one or more long acting bronchodilators (e.g. long acting Ξ²2 agonist \[LABA\], long acting muscarinic antagonist \[LAMA\]) with or without an inhaled corticosteroid maintenance therapy for their COPD.
β. Patients who produce sputum most days.
β. Provide written informed consent.
Exclusion criteria
β. Any condition, including findings in the medical history or in the pre-randomisation assessments that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation.
β. Current treatment or treatment within the past 6 weeks with oral corticosteroids.
β
What they're measuring
1
Forced Expiratory Volume in 1 second (FEV1)
Timeframe: from Baseline (pre-treatment on day 1) to day 3
2
Peak Expiratory Flow Rate (PEFR)
Timeframe: from Baseline (pre-treatment on day 1) to day 3
3
Anti-viral IFN-stimulated genes in cells from expectorated sputum.
Timeframe: from Baseline (pre-treatment on day 1) to day 13
4
CXCL10 in blood samples.
Timeframe: from Baseline (pre-treatment on day 1) to day 13
β. Patients who require any form of oxygen therapy or non-invasive ventilation.
β. The patient has received live/attenuated vaccines in the past six weeks prior to randomisation or inactivated/killed, subunit or conjugate vaccines in the past two weeks prior to randomisation.
β. Current or previous participation in another clinical trial where the patient has received a dose of an investigational medicinal product (IMP) containing small molecules within 12 weeks prior to entry into this study or containing biologicals within 12 months prior to entry into this study.
β. Active interstitial lung disease or past history of lung cancer not considered cured, significant bronchiectasis, cystic fibrosis, alpha-1 antitrypsin deficiency or a history of significant chronic asthma.
β. Patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact the interpretation of results (e.g. non respiratory infections, haematological disease, malignancy, renal disease, hepatic disease, coronary heart disease or other cardiovascular disease \[including arrhythmias\], endocrine or gastrointestinal disease).