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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
49
UK Site 2
Belfast, United Kingdom
UK Site 3
London, United Kingdom
UK Site 1
Manchester, United Kingdom
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
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