Cough
Conditions
Keywords
Chronic Cough, Indantadol
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\[1-3\].
Interventions
DRUGIndantadol
Titration
Sponsors
Manchester University NHS Foundation Trust
Vernalis (R&D) Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective cough frequency at 8 weeks compared to baseline. | 8 Weeks |
Secondary
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed