deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT03570359

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.

Updated 8 times since 2018 Last updated: Jan 3, 2023 Started: Jan 29, 2018 Primary completion: May 5, 2020 Completion: May 5, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jul 2018 – ~Jan 2019 · 6 months · monthly snapshotActive Not Recruiting~Jan 2019 – ~Jun 2019 · 5 months · monthly snapshotRecruiting~Jun 2019 – ~Jan 2021 · 19 months · monthly snapshotRecruiting~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotRecruiting~Oct 2021 – ~Feb 2023 · 16 months · monthly snapshotUnknown Status~Feb 2023 – ~Jul 2024 · 17 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Feb 2023 — Jul 2024 [monthly]

    Completed PHASE2

    Status: Unknown StatusCompleted

  4. Oct 2021 — Feb 2023 [monthly]

    Unknown Status PHASE2

    Status: RecruitingUnknown Status

  5. Jan 2021 — Oct 2021 [monthly]

    Recruiting PHASE2

Show 3 earlier versions
  1. Jun 2019 — Jan 2021 [monthly]

    Recruiting PHASE2

  2. Jan 2019 — Jun 2019 [monthly]

    Recruiting PHASE2

    Status: Active Not RecruitingRecruiting

  3. 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

Sponsor contact:
  • Synairgen Research Ltd.
Data source: Synairgen Research Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .