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

Xention

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: XEN-D0501; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02233686

XEN-D0501-CL-05

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male/female subjects aged 40 or over with COPD

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

XEN-D0501

Experimental group

Description:

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

Treatment:

Drug: XEN-D0501

Placebo to Match

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo