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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414541
• Other study ID #: DS102A-03
• Status: Completed
• Phase: Phase 2
• Start date: September 24, 2017
• Est. completion date: January 29, 2019

Study information

• Verified date: January 2020
• Source: Afimmune
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 29, 2019
• Est. primary completion date: January 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• DS102
DS102

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	UK Site 2	Belfast
United Kingdom	UK Site 3	London
United Kingdom	UK Site 1	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Afimmune

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in induced sputum differential neutrophil count from baseline to Week 12		12 weeks
Primary	Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.		12 Weeks
Secondary	Change in induced sputum neutrophil differential count from baseline		14 weeks
Secondary	Change in St Georges Respiratory Questionnaire (SGRQ) from baseline	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.	14 weeks