Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: DS102; Other: Placebo

• Registration Number: NCT03414541
• Lead Sponsor: Afimmune

Brief Summary

The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to assess the safety and efficacy of orally administered DS102 capsules versus placebo in the treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-24
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Primary Completion: 2019-01-11
• Study Completion: 2019-01-29
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Patients (male or female) aged 40-75 years with stable COPD at the time of screening.
• Patients who are current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack- years are defined as 20 cigarettes a Day for 10 years, or 10 cigarettes a Day for 20 years).
• Patients whose pre-study clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator.
• Patients who are able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.

Exclusion Criteria

• Patients with a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
• Patients with significant systemic or major illness other than pulmonary disease, including coronary artery disease, liver disease, cerebrovascular disease, renal insufficiency, serious psychiatric disease, respiratory or hypertensive disease, as well as diabetes and arthritis that, in the opinion of the Investigator, would preclude the patient from participating in and completing the study.
• Patients with known hypersensitivity to any ingredients of the study treatment.
• Patients, in the opinion of the Investigator, not suitable to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
500mg DS102	DS102	Participants in this group will receive 500 mg DS102 capsules twice daily.
Placebo	Placebo	Participants in this group will receive matching placebo capsules twice daily.
1000mg DS102	DS102	Participants in this group will receive 1000 mg DS102 capsules twice daily.

Primary Outcome Measures

Name	Time	Method
Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.	12 Weeks
Change in induced sputum differential neutrophil count from baseline to Week 12	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in induced sputum neutrophil differential count from baseline	14 weeks
Change in St Georges Respiratory Questionnaire (SGRQ) from baseline	14 weeks	Questionnaire designed to measure impact of COPD on overall health, daily life and perceived well-being. Scores range from 0 -100 with higher scores indicating more limitations.

Trial Locations

Locations (3)

UK Site 2; 🇬🇧 Belfast, United Kingdom

UK Site 1; 🇬🇧 Manchester, United Kingdom

UK Site 3; 🇬🇧 London, United Kingdom