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

• Sponsor: Xention Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02233686
• Collaborator: Ario Pharma Ltd (Industry)
• Enrollment: 27
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: XEN-D0501; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XEN-D0501 4mg BID Days 1-13, 4mg once daily (OD) Day 14	Drug: XEN-D0501
Placebo Comparator: Placebo to Match BID Days 1-13, once daily (OD) Day 14	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Change from baseline at the end of each treatment period in objective daytime cough frequency [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male/female subjects aged 40 or over with COPD

Exclusion Criteria:

• Clinically significant medical history

• Abnormal laboratory results, ECGs or vital signs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medicines Evaluation Unit	Manchester		United Kingdom	M23 9QZ

Sponsors and Collaborators

• Xention Ltd
• Ario Pharma Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xention Ltd
• ClinicalTrials.gov Identifier: NCT02233686
• Other Study ID Numbers: XEN-D0501-CL-05
• First Posted: Sep 8, 2014
• Last Update Posted: Jul 15, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jul 15, 2015