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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Synairgen Research Ltd. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess the safety of inhaled SNG001 and the ability of inhaled SNG001 to 'switch on' the cells' anti-viral defences in patients with chronic obstructive pulmonary disease (COPD). The study consist of two parts. Part 1 will assess the safety of inhaled SNG001 in ten patients with stable COPD. Part 2 will assess efficacy and safety of inhaled SNG001 in 120 patients with COPD with a cold or COPD exacerbation.

Detailed description

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Interferon Beta-1A	Interferon Beta-1A via inhalation
OTHER	Placebo	Placebo via inhalation

Timeline

• Start date: 2018-01-29
• Primary completion: 2020-05-05
• Completion: 2020-05-05
• First posted: 2018-06-27
• Last updated: 2023-01-04

Locations

16 sites across 1 country: United Kingdom