Clinical trial NCT01401673: Phase II Open-Label Pilot Study of V3381 in Chronic Cough
Official title: Phase II Open-label Pilot Study of V3381, a Novel N-Methyl-D-Aspartate Receptor Antagonist, in Chronic Cough Patients Attending a Specialist Clinic
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cough
Keywords: Chronic Cough
Indantadol
Lead sponsor: Vernalis (R&D) Ltd
Sponsor class: INDUSTRY
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2011-07-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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\[1-3\].


Eligibility criteria: 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).

Primary outcomes:
measure: Objective cough frequency at 8 weeks compared to baseline.
timeFrame: 8 Weeks
Secondary outcomes:
measure: Change in objective cough frequency at 4 weeks.
timeFrame: 4 Weeks
measure: Change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) at 4 and 8 weeks.
timeFrame: 4 and 8 Weeks
measure: Change in Global Rating of Change Scale at 1 week, 2 weeks, 4 weeks and 8 weeks
timeFrame: 1 Week, 2 Weeks, 4 Weeks and 8 Weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: South Manchester University Hospital
Study officials:
affiliation: South Manchester University Hospital
name: Ashley Woodcock, Prof.
role: PRINCIPAL_INVESTIGATOR
References: