A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With COPD
Phase 2
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT02233686
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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
- 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 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medicines Evaluation Unit
🇬🇧Manchester, United Kingdom