Phase II Open-Label Pilot Study of V3381 in Chronic Cough

Study Overview
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Brief Summary
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The investigators hypothesise that cough reflex hypersensitivity, demonstrated in chronic cough patients, is due to a phenomenon known as central sensitisation. Central sensitisation is a hyper-excitability of the sensory nerves as they join the central nervous system, and is believed to be mediated by the N-Methyl-D-Aspartate (NMDA) receptor[1-3].

Official Title
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Phase II Open-label Pilot Study of V3381, a Novel N-Methyl-D-Aspartate Receptor Antagonist, in Chronic Cough Patients Attending a Specialist Clinic

Conditions
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Cough

Intervention / Treatment
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* Drug: Indantadol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18-75 years of age Females must be of non child-bearing potential Chronic Cough ( > 8 weeks) Normal Chest X-ray Normal Lung Function Idiopathic or treatment resistant cough- Exclusion Criteria: Recent upper respiratory tract infection (<4 weeks) Pregnancy/breast-feeding Current smokers or ex-smokers with <6 months abstinence or cumulative history of >10 pack years Current treatment with ACE inhibitors. Drug or alcohol abuse Uncontrolled hypertension (i.e., >140/90 mmHg despite adequate medical therapy). Any cardiovascular condition that would be a contra-indication to the use of sympathomimetic amines (e.g. active angina). Any clinically significant neurological disorder Prior renal transplant, current renal dialysis. Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study. Increased risk of seizures. Any malignancy in the past 2 years (with the exception of basal cell carcinoma). Use of opioids, anticonvulsants, antidepressants (particularly MAO inhibitors). Any clinically significant abnormal laboratory test result(s). Serum creatinine laboratory value greater than 1.5 x upper limit of normal (ULN) reference range (after adjustment for age) or estimated creatinine clearance <60 mL/min. Total bilirubin greater than upper limit of normal reference range (with the exception of Gilbert's Syndrome) and/or alanine transaminase (ALT) >1.5 times upper limit of normal reference ranges (after adjustment for age).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indantadol|Titration|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective cough frequency at 8 weeks compared to baseline. |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in objective cough frequency at 4 weeks. |  | 4 Weeks | 
| Change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) at 4 and 8 weeks. |  | 4 and 8 Weeks | 
| Change in Global Rating of Change Scale at 1 week, 2 weeks, 4 weeks and 8 weeks |  | 1 Week, 2 Weeks, 4 Weeks and 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Cough, Indantadol