Chronic Obstructive Pulmonary Disease
Conditions
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).
Interventions
DRUGDS102
DS102
OTHERPlacebo
Placebo
Sponsors
Afimmune
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in induced sputum neutrophil differential count from baseline | 14 weeks | — |
| Change in St Georges Respiratory Questionnaire (SGRQ) from baseline | 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. |
Countries
United Kingdom
Outcome results
None listed