Inhaled CCI15106 - in healthy volunteers and COPD patients; version 1
Research type
Research Study
Full title
A double-blind (sponsor unblind), randomized, placebo-controlled, single and repeat escalating dose study to investigate the safety, tolerability, and pharmacokinetics of CCI15106 inhalation powder in healthy participants and participants with moderate chronic obstructive pulmonary disease (COPD) including evaluation of environmental and healthy by-stander exposure levels during dosing.
IRAS ID
225869
Contact name
Jeremy Dennison
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2017-001070-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Chronic obstructive pulmonary disease (COPD) is a condition where the airways in the lungs become damaged and inflamed (swollen and irritated). People with COPD are more likely than healthy people to get virus infections in their lungs. CCI15106-IP is a dry powder that’s inhaled through the mouth via a new inhaler. We hope CCI15106-IP will help COPD patients fight virus infections in their lungs.\n\nThe study will have 2 parts and will include 36 healthy people (aged 18–65 years) and 22 people with COPD (aged 40-75 years). We’ll aim to find out CCI15106-IP side effects, blood levels and measure the amount that gets into the lungs. Each participant will have 2 outpatients visits and a stay on the ward.\n\nIn Part 1, we’ll give 8 healthy volunteers single and repeated doses of CCI15106-IP or placebo; they’ll stay on the ward for 22 nights and take up to 12 weeks to finish the study. We’ll also give 14 healthy volunteers daily doses of CCI15106 or placebo and at the same time, test exposure of CCI15106-IP in the air in 14 healthy volunteers (‘bystanders’); they’ll stay on the ward for 15 nights and take up to 11 weeks to finish the study.\n\nIn Part 2, we’ll give 8 people with COPD single doses of CCI15106 or placebo; they’ll stay on the ward for 2 nights and take up to 11 weeks to finish the study. We’ll also give 14 people with COPD daily doses of CCI15106 or placebo; they’ll stay on the ward for 15 nights and take up to 13 weeks to finish the study.\n\nA pharmaceutical company GlaxoSmithKline is funding the study.\n\nThe study will take place at 1 centre in London.\n\n
REC name
London - Harrow Research Ethics Committee
REC reference
17/LO/0536
Date of REC Opinion
27 Jun 2017
REC opinion
Further Information Favourable Opinion