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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
122
Interferon Beta-1A via inhalation
Placebo via inhalation
Celerion
Belfast, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Forced Expiratory Volume in 1 second (FEV1)
Part 1
Time frame: from Baseline (pre-treatment on day 1) to day 3
Peak Expiratory Flow Rate (PEFR)
Part 1
Time frame: from Baseline (pre-treatment on day 1) to day 3
Anti-viral IFN-stimulated genes in cells from expectorated sputum.
Part 2
Time frame: from Baseline (pre-treatment on day 1) to day 13
CXCL10 in blood samples.
Part 2
Time frame: from Baseline (pre-treatment on day 1) to day 13
Part 1-Safety, adverse events
To be assessed on the number of reported adverse events
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
Part 1-Safety, laboratory values
To be assessed on changes in laboratory values
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
Part 1-Safety, vital signs
To be assessed on changes in vital signs
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
Part 1-Safety, lung function
To be assessed on changes in lung function
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
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Tower Family Health Care
Bury, United Kingdom
Lakeside Healthcare
Corby, United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom
Hemel Hempstead Hospital
Hemel Hempstead, United Kingdom
Hull Royal Infirmary
Hull, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Queen Anne Medical Centre
London, United Kingdom
...and 6 more locations
Part 1-Safety, concomitant medication
To be assessed on changes in concomitant medication
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
Part 1- Tolerability, adverse events
To be assessed by reviewing adverse events
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
Part 1- Tolerability, laboratory values
To be assessed by reviewing changes in laboratory values
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
Part 1- Tolerability, vital signs
To be assessed by reviewing changes in vital signs
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
Part 1- Tolerability, lung function
To be assessed by reviewing changes in lung function
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
Part 1- Tolerability, concomitant medication
To be assessed by reviewing changes in concomitant medication
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
Part 1-Biomarker 1
Changes in sputum differential cell counts
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
Part 1-Biomarker 2
To evaluate and compare anti-viral IFN-stimulated genes in cells from expectorated sputum for SNG001 versus placebo
Time frame: from Baseline (pre-treatment on day 1) to day 7-10
Part 2-Efficacy 1 changes in lung function
Evaluate and compare changes in lung function during the study period SNG001 with placebo
Time frame: from Baseline (pre-treatment on day 1) to day 13
Part 2-Efficacy-2 BCSS score
Evaluate and compare BCSS score of SNG001 with placebo
Time frame: from Baseline (pre-treatment on day 1) to day 13
Part 2-Efficacy-3 changes in BCSS symptom score
Evaluate and compare changes in BCSS symptom score during the study period of SNG001 with placebo
Time frame: from Baseline (pre-treatment on day 1) to day 13
Part 2-Efficacy-4 return to normal (day to day) symptoms
Evaluate and compare time to return to normal (day to day) symptoms post a moderate exacerbation (Group B only) of SNG001 with placebo
Time frame: from Baseline (pre-treatment on day 1) to day 13
Part 2-Efficacy-5 viral and bacterial load
Evaluate and compare sputum viral and bacterial load of SNG001 with placebo
Time frame: from Baseline (pre-treatment on day 1) to day 13
Part 2-Efficacy-6 reliever medication usage
Evaluate and compare reliever medication usage during the treatment period of SNG001 with placebo
Time frame: from Baseline (pre-treatment on day 1) to 13
Part 2-Efficacy-7 antibiotic and oral corticosteroid usage
Evaluate and compare antibiotic and oral corticosteroid usage during the study period of SNG001 with placebo
Time frame: from Baseline (pre-treatment on day 1) to day 13
Part 2-Efficacy-8 patient perceived efficacy
Evaluate and compare patient perceived efficacy of SNG001 with placebo
Time frame: from Baseline (pre-treatment on day 1) to day 13
Part 2-Safety, adverse event
To be assessed on the number of reported adverse events
Time frame: from Baseline (pre-treatment on day 1) to day 28
Part 2-Safety, laboratory values
To be assessed on changes in laboratory values
Time frame: from Baseline (pre-treatment on day 1) to day 28
Part 2-Safety, vital signs
To be assessed on changes in vital signs
Time frame: from Baseline (pre-treatment on day 1) to day 28
Part 2-Safety, concomitant medication
To be assessed on changes in concomitant medication
Time frame: from Baseline (pre-treatment on day 1) to day 28
Part 2- Tolerability, adverse events
To be assessed by reviewing adverse events
Time frame: from Baseline (pre-treatment on day 1) to day 28
Part 2- Tolerability, laboratory changes
To be assessed by reviewing changes in laboratory values
Time frame: from Baseline (pre-treatment on day 1) to day 28
Part 2- Tolerability, vital signs
To be assessed by reviewing changes in vital signs
Time frame: from Baseline (pre-treatment on day 1) to day 28
Part 2- Tolerability,concomitant medication
To be assessed by reviewing changes in concomitant medication
Time frame: from Baseline (pre-treatment on day 1) to day 28