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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02233686
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : July 15, 2015
Ario Pharma Ltd
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
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 : February 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Change from baseline at the end of each treatment period in objective daytime cough frequency [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02233686

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United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Xention Ltd
Ario Pharma Ltd
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Responsible Party: Xention Ltd Identifier: NCT02233686    
Other Study ID Numbers: XEN-D0501-CL-05
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases