A Phase 2 interventional study of DS102 and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Afimmune. Completed at 3 sites in United Kingdom. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-31.
Sponsored by Afimmune · Phase 2, Interventional, and Treatment
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).
Exclusion Criteria:
Participants in this group will receive matching placebo capsules twice daily.
Other: Placebo
Participants in this group will receive 500 mg DS102 capsules twice daily.
Drug: DS102
Participants in this group will receive 1000 mg DS102 capsules twice daily.
Drug: DS102
DS102
Placebo
Change in induced sputum differential neutrophil count from baseline to Week 12
Time frame: 12 weeks
Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.
Time frame: 12 Weeks
Change in induced sputum neutrophil differential count from baseline
Time frame: 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.
Time frame: 14 weeks
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Afimmune