Back to resultsSafety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
DS102
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
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
Sites / Locations
- UK Site 2
- UK Site 3
- UK Site 1
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
500mg DS102
1000mg DS102
Arm Description
Participants in this group will receive matching placebo capsules twice daily.
Participants in this group will receive 500 mg DS102 capsules twice daily.
Participants in this group will receive 1000 mg DS102 capsules twice daily.
Outcomes
Primary Outcome Measures
Change in induced sputum differential neutrophil count from baseline to Week 12
Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.
Secondary Outcome Measures
Change in induced sputum neutrophil differential count from baseline
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03414541
Brief Title
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 24, 2017 (Actual)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
January 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Afimmune
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this group will receive matching placebo capsules twice daily.
Arm Title
500mg DS102
Arm Type
Experimental
Arm Description
Participants in this group will receive 500 mg DS102 capsules twice daily.
Arm Title
1000mg DS102
Arm Type
Experimental
Arm Description
Participants in this group will receive 1000 mg DS102 capsules twice daily.
Intervention Type
Drug
Intervention Name(s)
DS102
Intervention Description
DS102
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in induced sputum differential neutrophil count from baseline to Week 12
Time Frame
12 weeks
Title
Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change in induced sputum neutrophil differential count from baseline
Time Frame
14 weeks
Title
Change in St Georges Respiratory Questionnaire (SGRQ) from baseline
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Pavord, MA DM FRCP FERS FMedSci
Organizational Affiliation
University of Oxford, Oxford, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
UK Site 2
City
Belfast
Country
United Kingdom
Facility Name
UK Site 3
City
London
Country
United Kingdom
Facility Name
UK Site 1
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
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Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
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