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Completed

NCT Number: NCT03414541

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

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).

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UK Site 2, Belfast, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DS102

Drug

DS102

Placebo

Other

Placebo

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

    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.

Sponsors and collaborators

Lead sponsor

Afimmune

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2018
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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