Skip to main content
OpenTrials
Completed

NCT Number: NCT02233686

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male/female subjects aged 40 or over with COPD

Exclusion criteria

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

Treatment and study plan

XEN-D0501

Drug

Placebo

Drug

Primary outcomes

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

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Xention Ltd

Industry

Collaborators

  • Ario Pharma Ltd

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 8, 2014
Registry last updated
Jul 15, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.