Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03414541
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Afimmune

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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: DS102 Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 24, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants in this group will receive matching placebo capsules twice daily.
Other: Placebo
Placebo

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414541


Contacts
Layout table for location contacts
Contact: Karen Doyle 00 353 1 2946385 karen.doyle@afimmune.com

Locations
Layout table for location information
United Kingdom
Manchester Evaluations Unit (MEU) Recruiting
Manchester, Wythenshawe, United Kingdom, M23 9QZ
Contact: Dave Singh       dsingh@meu.org.uk   
Celerion Recruiting
Belfast, United Kingdom, BT9 6AD
Contact: Abou Farha Khalid       khalid.aboufarha@celerion.com   
Sponsors and Collaborators
Afimmune

Layout table for additonal information
Responsible Party: Afimmune
ClinicalTrials.gov Identifier: NCT03414541     History of Changes
Other Study ID Numbers: DS102A-03
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases