Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT03414541|
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : February 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: DS102 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||September 24, 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||November 2018|
Placebo Comparator: Placebo
Participants in this group will receive matching placebo capsules twice daily.
Experimental: 500mg DS102
Participants in this group will receive 500 mg DS102 capsules twice daily.
Experimental: 1000mg DS102
Participants in this group will receive 1000 mg DS102 capsules twice daily.
- 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 [ Time Frame: 14 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414541
|Contact: Karen Doyle||00 353 1 firstname.lastname@example.org|
|Manchester Evaluations Unit (MEU)||Recruiting|
|Manchester, Wythenshawe, United Kingdom, M23 9QZ|
|Contact: Dave Singh email@example.com|
|Belfast, United Kingdom, BT9 6AD|
|Contact: Abou Farha Khalid firstname.lastname@example.org|