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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants in this group will receive matching placebo capsules twice daily. |
|
| 500mg DS102 | Experimental | Participants in this group will receive 500 mg DS102 capsules twice daily. |
|
| 1000mg DS102 | Experimental | Participants in this group will receive 1000 mg DS102 capsules twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS102 | Drug | DS102 |
| |
| Placebo |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Pavord, MA DM FRCP FERS FMedSci | University of Oxford, Oxford, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UK Site 2 | Belfast | United Kingdom | ||||
| UK Site 3 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Other |
Placebo |
|
| 14 weeks |
| London |
| United Kingdom |
| UK Site 1 | Manchester | United Kingdom |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |