Clinical trial NCT03414541: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Afimmune
Sponsor class: INDUSTRY
First posted: 2018-01-30
Enrollment: 49
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in induced sputum differential neutrophil count from baseline to Week 12
timeFrame: 12 weeks
measure: Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in induced sputum neutrophil differential count from baseline
timeFrame: 14 weeks
measure: Change in St Georges Respiratory Questionnaire (SGRQ) from baseline
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: UK Site 2
city: London
country: United Kingdom
facility: UK Site 3
city: Manchester
country: United Kingdom
facility: UK Site 1
Study officials:
affiliation: University of Oxford, Oxford, UK
name: Ian Pavord, MA DM FRCP FERS FMedSci
role: PRINCIPAL_INVESTIGATOR
References: