Safety & Efficacy Study of Orally Administered DS102 in COPD Patients
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase IIa Study to Assess the Safety And Efficacy of Orally Administered DS102 in Chronic Obstructive Pulmonary Disease Patients.
IRAS ID
215570
Contact name
Karen Doyle
Contact email
Sponsor organisation
Afimmune
Eudract number
2016-002853-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 7 days
Research summary
DS102 is being developed for the treatment of COPD. \n\nThis is a randomised, placebo-controlled, double-blind, parallel group, exploratory Phase IIa study to investigate the safety and efficacy of orally administered DS102 capsules and the dose-response relationship between two doses of DS102 and placebo over a 12-week treatment period. \n\nThe study will enrol male and female COPD patients aged between 40 and 75 years inclusive.\n\nAt the screening visit, after giving informed consent, patients will be assessed using the screening examinations. \n\nIt is planned that 45 evaluable patients, 30 patients in active treatment group and 15 patients in the control placebo treatment group will be randomized to either of the following parallel treatment groups:\n\nTreatment Group A: 2 x Placebo 500mg capsules orally administered twice a Day (4 capsules daily) for 12 weeks. \n\nTreatment Group B: 1 x DS102 500mg capsule & 1 x Placebo 500mg capsule orally administered twice a Day (4 capsules daily) for 12 weeks.\n\nTreatment Group C: 2 x DS102 500mg capsules orally administered twice a Day (4 capsules daily) for 12 weeks.\n\nThis is an outpatient study consisting of a screening period of 28 Days, a 12-week treatment period and a 2-week follow up period as follows: \n\nFive outpatient visits to the clinic are scheduled, a screening visit, one at the start of the comparative treatment period and three in the comparative treatment period. A final safety follow-up visit, will be conducted two weeks after the last visit in the treatment period.\n\nAll patients will complete the study at the week 12 visit.
REC name
HSC REC B
REC reference
17/NI/0103
Date of REC Opinion
20 Jun 2017
REC opinion
Favourable Opinion