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

Afimmune

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Placebo; Drug: DS102

Study type: Interventional

Funder types: Industry

Identifiers

NCT03414541

DS102A-03

Details and patient eligibility

About

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).

Enrollment: 49 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants in this group will receive matching placebo capsules twice daily.

Treatment:

Other: Placebo

500mg DS102

Experimental group

Description:

Participants in this group will receive 500 mg DS102 capsules twice daily.

Treatment:

Drug: DS102

1000mg DS102

Experimental group

Description:

Participants in this group will receive 1000 mg DS102 capsules twice daily.

Treatment:

Drug: DS102