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

Study Overview
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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).

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: DS102
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants in this group will receive matching placebo capsules twice daily. | Other: Placebo<br>* Placebo<br>|
| Experimental: 500mg DS102<br>Participants in this group will receive 500 mg DS102 capsules twice daily. | Drug: DS102<br>* DS102<br>|
| Experimental: 1000mg DS102<br>Participants in this group will receive 1000 mg DS102 capsules twice daily. | Drug: DS102<br>* DS102<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in induced sputum differential neutrophil count from baseline to Week 12 |  | 12 weeks | 
| Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation. |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in induced sputum neutrophil differential count from baseline |  | 14 weeks | 
| 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 |