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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-24

Study Completion Date

2019-01-29

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

500mg DS102

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

Group Type EXPERIMENTAL

DS102

Intervention Type DRUG

DS102

1000mg DS102

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

Group Type EXPERIMENTAL

DS102

Intervention Type DRUG

DS102

Interventions

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DS102

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No