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

Xention Ltd18 enrolled

Overview

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 idiopathic cough. The effectiveness of XEN-D0501 over 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 and Leicester Cough Questionnaire (LCQ) will be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Idiopathic Cough

Interventions

XEN-D0501DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male/female subjects aged 18 or over with chronic idiopathic cough Exclusion Criteria: * Clinically significant medical history * Abnormal laboratory results, ECGs or vital signs

Locations (2)

Belfast City Hospital

Belfast, Ireland

University Hospital of South Manchester

Manchester, United Kingdom

Outcomes

Primary Outcomes

Change from baseline at the end of each treatment period in objective daytime cough frequency on XEN-D0501 compared to placebo

Time frame: 12 weeks

Data from ClinicalTrials.gov

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