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

NCT03414541 | Completed Phase 2

• 1 other identifier: DS102A-03
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 3

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).

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in induced sputum neutrophil differential count from baseline

  14 weeks

• Change in St Georges Respiratory Questionnaire (SGRQ) from baseline

  14 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

500mg DS102

EXPERIMENTAL

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

Drug: DS102

1000mg DS102

EXPERIMENTAL

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

Drug: DS102

Interventions

DS102 DRUG

DS102

1000mg DS102; 500mg DS102

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Afimmune: lead

Study Sites (3)

UK Site 2

Belfast, United Kingdom

Location

UK Site 3

London, United Kingdom

Location

UK Site 1

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian Pavord, MA DM FRCP FERS FMedSci

  University of Oxford, Oxford, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: September 24, 2017
• Primary Completion: January 11, 2019
• Study Completion: January 29, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

GB (3)