A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough
- Registration Number
- NCT02233699
- Lead Sponsor
- Xention Ltd
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo to Match Placebo BID Days 1-13, once daily (OD) Day 14 XEN-D0501 XEN-D0501 4mg BID Days 1-13, 4mg once daily (OD) Day 14
- Primary Outcome Measures
Name Time Method Change from baseline at the end of each treatment period in objective daytime cough frequency on XEN-D0501 compared to placebo 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Belfast City Hospital
🇮🇪Belfast, Ireland
University Hospital of South Manchester
🇬🇧Manchester, United Kingdom