Phase II Open-Label Pilot Study of V3381 in Chronic Cough
Phase 2
Terminated
- Conditions
- Cough
- Registration Number
- NCT01401673
- Lead Sponsor
- Vernalis (R&D) Ltd
- Brief Summary
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\[1-3\].
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Objective cough frequency at 8 weeks compared to baseline. 8 Weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
South Manchester University Hospital
🇬🇧Manchester, United Kingdom