Comparing efficacy and safety of inhaled SNG001 to placebo
A randomised, double-blind, placebo-controlled Phase II study, comparing the efficacy and safety of inhaled SNG001 to placebo administered to asthmatic subjects after the onset of a respiratory viral infection for the prevention or attenuation of asthma symptoms caused by respiratory viruses
Synairgen Research Limited
When people with asthma get a respiratory virus such as a cold or flu it often increases asthma symptoms. We will test the study medication to find out if it can prevent the virus spreading from the nose to the lungs.
SNG001 contains Interferon-ß (an antiviral protein) that occurs naturally in the body. Interferon-ß is taken by injection by thousands of multiple sclerosis patients. In this study, SNG001 will be given by a nebuliser.
Asthmatic lung cells do not make enough interferon-ß when they are infected by the common cold virus. When normal amounts of interferon-ß are added to the asthma cells they mount an anti-viral response.
Asthmatic subjects (with a history of exacerbations caused by viruses) will be recruited from databases, and through advertising. Eligible subjects will wait (maybe for months) until they start to develop cold or flu symptoms. Treatment with placebo or interferon-ß will start within 24 hours of virus symptoms developing. To see if the therapy is working, subjects will answer daily questions about their symptoms by text message, and once weekly by phone. Subjects will also visit the study sites (5-10 specialist respiratory centers, mostly in the UK), where they will do lung function tests (blowing tests). Samples from the nose (snot), phlegm from the lungs, and blood will be taken.
It will take approximately 9 to 15 months for the whole study to be completed. Subjects will take the medication for 14 days, and will be monitored for a further 2 weeks following the completion of the treatment. 120 subjects need to complete the trial, however because not everyone will get a cold during the trial period, and not everyone will be able to get to a trial centre quickly enough when they do get a cold, approximately 300 subjects will start the study.
South Central - Hampshire A Research Ethics Committee
Date of REC Opinion
3 Mar 2010
Further Information Favourable Opinion