ION-827359 in Mild to Moderate COPD with Chronic Bronchitis
Research type
Research Study
Full title
A Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Patients with Mild to Moderate COPD with Chronic Bronchitis
IRAS ID
283247
Contact name
Brian Leaker
Contact email
Eudract number
2020-000210-15
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 9 months, 2 days
Research summary
Chronic Bronchitis (CB) can be a part of Chronic Obstructive Pulmonary Disease, and is characterised by excessive coughing and mucus secretion. This makes patients with Chronic Bronchitis more prone to lower respiratory infections (bronchitis and pneumonia) and is linked to lung disease progression and mortality.
ION-827359 is a new inhaled investigational drug being developed for the purpose of treating lung disease symptoms in patients with COPD with Chronic Bronchitis. ION-827359 is intended to help treat the thick mucus found in the airways.
The aim of this study is to test the effects of ION-827359 on the lung function and symptoms of participants with COPD with CB. In addition, the study will test how much ION-827359 is in the blood and urine of participants and to find out about the safety of ION-827359.
The dose levels will differ between groups. There will be two different doses of ION-827359 or placebo (a dummy drug with no active ingredient). Doses will be given once a week for 13 weeks both in-clinic and at home for a total of 13 doses.
There are two groups of participants:
• Cohort 1 will have 90 participants who will receive 1.5mL of ION-827359 or placebo
• Cohort 2 will have 90 participants who will receive 3mL of ION-827359 or placeboION-827359 has not yet been approved by any regulatory authority for marketing in any country.
Approximately 180 participants with COPD with CB, aged 40-70, will take part in this clinical study. Study duration will be approximately 27 weeks including a screening period, 13 weeks of treatment and 10 weeks follow-up. Approximately 30 different study centres throughout Europe will participate.
Study procedures include: physical examination, vital signs, bloods, urine, sputum, breathing tests, recording of the heart (ECG), electronic diary and possibly CT scans and bronchoscopies.
REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/1007
Date of REC Opinion
8 Oct 2020
REC opinion
Further Information Favourable Opinion