Prevention or attenuation of COPD symptoms caused by respiratory viruses
Conditions
Interventions
Product Name: interferon beta-1a (IFN-ß1a)
Product Code: SGN001
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: interferon beta-1a
Concentration unit: million IU million international uni
Sponsors
Synairgen Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Male or female, over 40 years of age. 2)A confirmed diagnosis of COPD or a medical history consistent with a diagnosis of COPD. 3)FEV1 > 20% of predicted and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)Any condition, including findings in the medical history that, in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct or evaluation. 2)Patients who have a current moderate or severe exacerbation of COPD. 3)Oxygen saturation of less than 92% (taken on air, unless the subject is routinely prescribed oxygen when they are stable). 4)Current participation in an interventional trial. 5)Patients who have received a dose of a test product (IMP) within 12 weeks prior to entry into the study for small molecules and within 6 months prior to entry into the study for biologicals. 6)Patients who have had a COPD exacerbation and/or upper or lower respiratory tract infection that resolved less than 4 weeks ago. 7)Patients who are currently taking, or have taken oral steroids or antibiotics within the last four weeks. 8)Active interstitial lung disease or past history of lung cancer not considered cured, significant bronchiectasis, cystic fibrosis or a history of significant chronic asthma. 9)Patients with serious underlying medical conditions that could impact interpretation of results should be excluded (e.g. infection, haematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease, including arrhythmias, endocrinological or gastrointestinal disease). 10)History of hypersensitivity to natural or recombinant IFN-ß or to any of the drug preparation excipients. 11)Patients with current severe depression and/or suicidal ideation. 12)History of epilepsy or seizures after the age of 5 years. 13)Recent history of drug or alcohol abuse. 14)Female who is breast-feeding, pregnant or intends to become pregnant. 15)Patients who require more than 12 hours’ oxygen therapy per day. 16)Patients who are currently in a pulmonary rehabilitation programme.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a Phase II study in which we are trying to see if SNG001 is better than placebo at controlling COPD symptoms during common cold infections. SNG001 is given by a nebulizer, and the solution contains interferon-ß, which is an antiviral protein (which we all have). We believe there is a deficiency of this protein in COPD patients when respiratory viruses are present. This may explain why COPD patients suffer an exacerbation (deterioration) of their symptoms when they get a cold (or flu). We will test the drug by looking to see if their COPD symptom (EXACT-Pro) peak score is lower in the SNG001 treated subjects compared to the placebo treated group between day 3 and day 14. The COPD score is a score calculated daily and consists of questions regarding the subjects COPD symptoms. We will have 83 subjects in each group. This has been calculated to be enough subjects to make a meaningful statistical comparison. ;Secondary Objective: This is the first time that a drug like SNG001 has been used to treat COPD subjects during common cold infections. As such the research team (led by experienced statisticians) will analyse data from a variety of other measurements made during the study. These will be: a) The same as the primary objective but looking at the per protocol population rather than the modified intention to treat population. b) To look at the EXACT-PRO scores in a number of different ways; specifically the peak score between days 3 and 28; to see if the area under the curve is lower in the SNG001 treated subjects compared to the placebo treated group between day 3 and day 7 and day 3 and day 28; and to look at the peak rolling day average between days 3 and 7 and days 3 and 28. c) To look at the effect of inhaled SNG001 to placebo on FEV1 between day 1 and 28. d) To compare the effect of inhaled SNG001 to placebo on the reduction of viral load on days 4 and 7 in sputum. e) To compare the effec;Primary end point(s): The primary e | — |
Countries
United Kingdom
Outcome results
None listed