Inhaled SNG001 in COPD patients
A randomised, double-blind, placebo-controlled study, in COPD patients with and without a confirmed respiratory virus infection assessing anti-viral biomarker responses and clinical effects of inhaled SNG001 compared to placebo.
Synairgen Research Limited
Duration of Study in the UK
1 years, 5 months, 0 days
When people with COPD get a respiratory virus such as a cold or flu it often increases COPD symptoms. SNG001 is the study medication, and it contains interferon beta which is a natural antiviral protein. We will test SNG001 to find out if it can boost anti-viral responses and minimise the worsening of COPD symptoms/lung function. Interferon-β is taken by injection by thousands of multiple sclerosis patients. In this study, SNG001 will be inhaled via a nebuliser. Lung cells of COPD patients do not fight the virus very well when they are infected by the common cold virus. When interferon-β is administered to the cells, it is thought that the anti-viral response is restored.
For the main part of the study, interested COPD Patients who consent to take part in the trial will be asked to contact the research team when they experience cold or flu symptoms or a deterioration of their COPD symptoms. At this point, eligible patients will undergo a virus detection test and those that test positive for a virus will be randomised 1:1 to receive 6 MIU SNG001 or placebo once daily for 14 days. Doses will be delivered in the clinic and at home, by a breath-actuated nebuliser. It is important that the first dose of study medication will be administered within 24 hours of the initial onset of upper respiratory virus symptoms or deterioration of COPD symptoms. Subjects will be assessed for changes in anti-viral biomarkers, lung function and COPD symptoms. Efficacy and safety will be monitored until at least 14 days post end of treatment.
Prior to the main part of the trial, 8 COPD patients will take three consecutive daily doses of SNG001 to make sure it is safe in COPD, it has been safely given to about 150 asthma patients up until now.
Summary of Results
Clinical Trial Results Summary Trial Title:
A randomised, double-blind, placebo-controlled trial, in COPD patients with and without a confirmed respiratory virus infection assessing antiviral biomarker responses and clinical effects of inhaled SNG001 compared to placebo.
Trial Number: SG015
This is a summary of the SG015 clinical trial results.
Synairgen Research Ltd is the sponsor of this trial and would like to share the results with the research participants and the public.
Synairgen would like to send a huge thank you to all research participants, as well as their family and friends, for their remarkable contribution to this study. Chronic Obstructive Pulmonary Disease (COPD) can have an impact on quality of life, particularly during a cold or chest infection. Despite that, participants in this study showed an incredible level of engagement and dedication to the trial in undertaking the required research activities.
We hope that this study summary can help all research participants understand and feel proud regarding their participation in research.
This summary is for informational purposes only. If you need medical advice, please contact your doctor. If you participated in this research study and have any questions about the results, please speak with a doctor or nurse at the study site.
Why was the research needed?
COPD is associated with long-term cigarette smoking and can cause symptoms such as cough, excessive sputum production and shortness of breath. Viruses such as flu and the common cold are known to cause a worsening of COPD symptoms (known as an exacerbation) in some individuals. These viruses and consequent exacerbations can severely impact on the patient’s quality of life, often taking weeks to recover and are a major healthcare burden. Exacerbations are often treated with oral corticosteroids and antibiotics.
Recent research suggested that Interferon-β, which is the main compound contained in the study medication, SNG001, might protect the cells in the lungs from cold and flu viruses in people who have COPD.
Researchers wanted to test the study medication to see if it can ‘switch on’ the cells in a way which would help them to fight viruses and to check that it does not affect lung function when inhaled by people with COPD. It is hoped that, one day, SNG001 will be given to people with COPD to treat the viral infection and prevent an exacerbation of COPD.
Who participated in the study?
This study was split in two parts. In Part 1, 13 patients with stable COPD and no infection received either SNG001 or placebo (dummy drug) for 3 days. In Part 2, 109 patients with COPD with a confirmed cold or chest infection caused by a respiratory virus received either SNG001 or placebo for 14 days.
This research took place across 16 research sites in the UK starting February 2018 and finishing May 2020.
The study medication was delivered to the lungs of patients through a handheld nebuliser.
What treatments or interventions did the participants take/receive?
During Part 1 of the study, patients with stable COPD (without a respiratory virus) received either SNG001 or placebo for 3 days. Patients were monitored for changes in their lung function and the study visits included lung function testing, vital signs, blood and sputum samples, adverse events, and changes in medication. All doses were given to patients once a day at the study site.
For Part 2, patients were asked to complete a daily questionnaire regarding their symptoms and use of medication. Their lung function was also monitored using a handheld device. When patients developed symptoms of a cold or chest infection or their COPD got worse, they were invited to attend for a study visit where they were tested for the presence of a respiratory virus. If the respiratory virus test was positive and the patient met all the study criteria, they were eligible to receive the study medication (SNG001 or placebo) once a day for 14 days.
Study visits occurred at Consent/Screening and on Days 1, 4, 7, 10, 13, 17 and 28. Patients could also be contacted by telephone on Day 56 (Visit 9) to gather information about their COPD. The study visits included lung function testing, vital signs (blood pressure, temperature and breathing rate), blood and sputum samples (at some study sites), adverse events and changes in medication.
What medical problems (adverse reactions) did the participants have?
For Part 1, there were a small number of medical events that were assessed by the study doctors to be related to SNG001 (3 out of 10) and placebo (2 out of 3). There were no events defined as serious during Part 1.
For Part 2, 9 patients out of 57 (16%) taking SNG001 had a medical event that was assessed by the study doctors to be related to SNG001 and 13 patients out of 52 (25%) that had a medical event assessed by the study doctors to be related to placebo.
Overall, for Part 2, 1 patient out of 57 (2%) had a medical event that was assessed by the study doctors to be serious and 3 patients out of 52 (6%) taking placebo had a medical event that was assessed by the study doctors to be serious.
The results showed the study medication was well tolerated by patients with COPD with a cold or chest infection, raising no safety concerns.
What were the results of this study?
This is a summary of the main results from this study. These are the results from all the participants combined. The individual results of each participant might be different and are not in this summary.
Deciding which treatments work best usually takes results from several studies. Other studies may provide new information or different results. Always talk to a doctor before making any treatment decisions.
The results showed that SNG001 (the study medication) was well tolerated by patients with COPD with a cold or chest infection, raising no safety concerns.
The study medication had a positive effect on one measurement of the lung function (a measurement of how well patients can breathe) for patients whose COPD had got worse and needed extra treatment. This was shown by improving their ability to breathe out quickly when compared to placebo. There was no difference between SNG001 and placebo in the patients with a virus whose COPD had not got worse, or bad enough to require extra treatment.
There was no difference between the study medication and the placebo in the patients’ symptoms, use of reliever medication and the time patients took to return to normal.
Of the patients who, at baseline, were positive for rhinovirus (a virus that causes the common cold), only a small number were able to provide sputum samples to measure how much virus was in the lungs. However, in these patients where sputum samples were provided there was a suggestion that viral clearance was faster in patients treated with SNG001 than placebo.
How has this research helped patients and researchers?
The results of this research have helped researchers understand more about how SNG001 might be able to be used to help patients with COPD that suffer from colds or chest infections. Further research is required to understand more about the use of the SNG001 in patients with a respiratory viral infection.
Where can I learn more about the study?
If you want to learn more about this study or about Synairgen Research, please use the link below:
• Synairgen Research Ltd: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbdEgv2L958AjlohfERqZQ10d59GVnjQYAFOW41MaKJSVs5BQ_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLqh3RMZ1uvP0RTe5XuFa8SqcvrqYsUT-2FrMoO73MgVLnagPPjFqGpi8pNsrk5HKDPaYq0a9BJkY6l7-2B35Z3-2BJcZaneSzNXI29RanhZnMiFHU4kNkGzCrBr5fTBRHMqRFNmgdsWAtEbPDZHuwXYe0Ukpd-2B6N3TI4HXQUnB4kGYhwxA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cb30877083fe048e2940008db26f09bfb%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638146587070957002%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Ucs9TGmVmoottJob2IaGvVGQzG3kZwdrGXi1O%2BiBUks%3D&reserved=0
Synairgen plc / Synairgen Research Ltd, Mailpoint 810, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, United Kingdom, Tel: +44 (0) 23 8051 2800
South Central - Hampshire A Research Ethics Committee
Date of REC Opinion
1 Dec 2017
Further Information Favourable Opinion