Trial | NCT02233686  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    xen-d0501 ...

  • Study Participants

    27
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.
Study Started
Feb 28
2014
Primary Completion
Feb 28
2015
Study Completion
Feb 28
2015
Last Update
Jul 15
2015
Estimate

Drug XEN-D0501

Drug Placebo

XEN-D0501 Experimental

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

Placebo to Match Placebo Comparator

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

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
No Results Posted