NCT02233686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

August 29, 2014

Last Update Submit

July 14, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline at the end of each treatment period in objective daytime cough frequency

    12 weeks

Study Arms (2)

XEN-D0501

EXPERIMENTAL

4mg BID Days 1-13, 4mg once daily (OD) Day 14

Drug: XEN-D0501

Placebo to Match

PLACEBO COMPARATOR

BID Days 1-13, once daily (OD) Day 14

Drug: Placebo

Interventions

XEN-D0501DRUG
XEN-D0501
PlaceboDRUG
Placebo to Match

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male/female subjects aged 40 or over with COPD

You may not qualify if:

  • Clinically significant medical history
  • Abnormal laboratory results, ECGs or vital signs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2014

First Posted

September 8, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations

GB(1)