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

Afimmune3 sites in 1 country49 target enrollmentSeptember 24, 2017

ConditionsChronic Obstructive Pulmonary Disease

InterventionsPlacebo DS102

DrugsDS102

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Afimmune
Enrollment: 49
Locations: 3
Primary Endpoint: Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 24, 2017

End Date

January 29, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Afimmune

Responsible Party

Sponsor

Eligibility Criteria

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