A Study to Test a Potential New Treatment for COPD Patients Suffering From the Common Cold or Influenza
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
Sponsor: Synairgen Research Ltd.
Listed as NCT03570359, this PHASE2 trial focuses on Chronic Obstructive Pulmonary Disease (COPD) and remains completed. Sponsored by Synairgen Research Ltd., it has been updated 8 times since 2018, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)When people with COPD get a respiratory virus such as a cold or flu it often increases their COPD symptoms, leading them to require treatment with either antibiotics or oral steroids and severely affecting their quality of life. SNG001 is the study medication, and it contains interferon beta (interferon-β) which is a natural antiviral protein. In this study we will look to see whether inhaled SNG001 can boost anti-viral responses and minimise the worsening of COPD symptoms/lung function when patients have a confirmed respiratory virus. In Part 1 ten COPD patients without a respiratory virus will be randomised to receive three days of SNG001 or placebo. The aim of this part of the study is to assess safety of SNG001 in COPD patients. In Part 2 COPD patients will 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 SNG001 or placebo once daily for 14 days. The first dose of study medication will be administered within 48 hours. Other assessments will be performed during the 14...
When people with COPD get a respiratory virus such as a cold or flu it often increases their COPD symptoms, leading them to require treatment with either antibiotics or oral steroids and severely affecting their quality of life. SNG001 is the study medication, and it contains interferon beta (interferon-β) which is a natural antiviral protein. In this study we will look to see whether inhaled SNG001 can boost anti-viral responses and minimise the worsening of COPD symptoms/lung function when patients have a confirmed respiratory virus.
In Part 1 ten COPD patients without a respiratory virus will be randomised to receive three days of SNG001 or placebo. The aim of this part of the study is to assess safety of SNG001 in COPD patients.
In Part 2 COPD patients will 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 SNG001 or placebo once daily for 14 days. The first dose of study medication will be administered within 48 hours. Other assessments will be performed during the 14 days of treatment to look for changes in anti-viral biomarkers, lung function and COPD symptoms. Patients will also be followed up 14 days post end of treatment.
Status Flow
Change History
8 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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Feb 2023 — Jul 2024 [monthly]
Completed PHASE2
Status: Unknown Status → Completed
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Oct 2021 — Feb 2023 [monthly]
Unknown Status PHASE2
Status: Recruiting → Unknown Status
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Jan 2021 — Oct 2021 [monthly]
Recruiting PHASE2
▶ Show 3 earlier versions
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Jun 2019 — Jan 2021 [monthly]
Recruiting PHASE2
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Jan 2019 — Jun 2019 [monthly]
Recruiting PHASE2
Status: Active Not Recruiting → Recruiting
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Jul 2018 — Jan 2019 [monthly]
Active Not Recruiting PHASE2
First recorded
Jan 2018
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Synairgen Research Ltd.
For direct contact, visit the study record on ClinicalTrials.gov .