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A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
XEN-D0501
Placebo
Sponsored by
Xention Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male/female subjects aged 40 or over with COPD

Exclusion Criteria:

  • Clinically significant medical history
  • Abnormal laboratory results, ECGs or vital signs

Sites / Locations

  • Medicines Evaluation Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

XEN-D0501

Placebo to Match

Arm Description

4mg BID Days 1-13, 4mg once daily (OD) Day 14

BID Days 1-13, once daily (OD) Day 14

Outcomes

Primary Outcome Measures

Change from baseline at the end of each treatment period in objective daytime cough frequency

Secondary Outcome Measures

Full Information

First Posted
August 29, 2014
Last Updated
July 14, 2015
Sponsor
Xention Ltd
Collaborators
Ario Pharma Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02233686
Brief Title
A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With COPD
Official Title
A Double-blind, Randomised, Placebo-controlled, Crossover Study to Assess the Efficacy of XEN-D0501, a Transient Receptor Potential Vanilloid Receptor 1 (TRPV1) Antagonist, in Reducing the Frequency of Cough in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xention Ltd
Collaborators
Ario Pharma Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in reducing the daytime cough frequency in patients with chronic obstructive pulmonary disease (COPD). The effectiveness of XEN-D0501 placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale [VAS]), urge to cough (via VAS), global rating of change scale, Clinical COPD Questionnaire (CCQ), Leicester Cough Questionnaire (LCQ), and St George's Respiratory Questionnaire (SGRQ-C) will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XEN-D0501
Arm Type
Experimental
Arm Description
4mg BID Days 1-13, 4mg once daily (OD) Day 14
Arm Title
Placebo to Match
Arm Type
Placebo Comparator
Arm Description
BID Days 1-13, once daily (OD) Day 14
Intervention Type
Drug
Intervention Name(s)
XEN-D0501
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline at the end of each treatment period in objective daytime cough frequency
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male/female subjects aged 40 or over with COPD Exclusion Criteria: Clinically significant medical history Abnormal laboratory results, ECGs or vital signs
Facility Information:
Facility Name
Medicines Evaluation Unit
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With COPD

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