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NCT02233686 Clinical Trial

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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02233686
Other study ID # XEN-D0501-CL-05
Secondary ID
Status Completed
Phase Phase 2
First received August 29, 2014
Last updated July 14, 2015
Start date February 2014
Est. completion date February 2015

Study information
Verified date July 2015
Source Xention Ltd
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Male/female subjects aged 40 or over with COPD

Exclusion Criteria:

- Clinically significant medical history

- Abnormal laboratory results, ECGs or vital signs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• XEN-D0501

• Placebo

Locations
Country Name City State
United Kingdom Medicines Evaluation Unit Manchester

Sponsors (2)
Lead Sponsor Collaborator
Xention Ltd Ario Pharma Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline at the end of each treatment period in objective daytime cough frequency 12 weeks No
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