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CompletedNCT03414541Updated Jan 31, 2020

Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease

A Phase 2 interventional study of DS102 and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Afimmune. Completed at 3 sites in United Kingdom. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-31.

Sponsored by Afimmune · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

03

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
49 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Participants in this group will receive matching placebo capsules twice daily.

    Other: Placebo

  • Experimental
    500mg DS102

    Participants in this group will receive 500 mg DS102 capsules twice daily.

    Drug: DS102

  • Experimental
    1000mg DS102

    Participants in this group will receive 1000 mg DS102 capsules twice daily.

    Drug: DS102

Interventions

  • DrugDS102

    DS102

  • OtherPlacebo

    Placebo

05

What researchers measure

Primary outcomes

  1. Change in induced sputum differential neutrophil count from baseline to Week 12

    Time frame: 12 weeks

  2. Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.

    Time frame: 12 Weeks

Secondary outcomes

  1. Change in induced sputum neutrophil differential count from baseline

    Time frame: 14 weeks

  2. 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

06

Study locations

3 sites
  • UK Site 2
    Belfast, United Kingdom
  • UK Site 3
    London, United Kingdom
  • UK Site 1
    Manchester, United Kingdom
07

Registry details

Key details

Study ID
NCT03414541
Lead sponsor
Afimmune
Responsible party
Sponsor
First posted
Jan 30, 2018
Start date
Sep 24, 2017
Primary completion
Jan 11, 2019
Completion
Jan 29, 2019
Last update
Jan 31, 2020

Study contacts

Ian Pavord, MA DM FRCP FERS FMedSci
principal investigator · University of Oxford, Oxford, UK

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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