Idiopathic and treatment resistant Chronic Cough MedDRA version: 14.1 Level: LLT Classification code 10066656 Term: Chronic cough System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Axura
Product Name: Memantine
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
University of Manchester
University Hospital of South Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Chronic cough (>8 weeks); - Normal chest x-ray; - FEV1 and FVC >70% predicted measured using spirometry; - Idiopathic or treatment resistant chronic cough, defined as a cough for which no objective evidence of an underlying trigger can be determined after routine clinical investigation (idiopathic) or a cough that did not respond to standard treatment for identified underlying triggers (treatment-resistant); - Females will be non-pregnant and non-lactating with no intention of pregnancy during study treatment. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Recent upper respiratory tract infection (1 years post-menopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test, performed at visit 1 prior to administration of study medication. - Current smokers or ex-smokers with 20 pack years; - Current treatment with ACE inhibitors; - Drug or alcohol abuse; - Uncontrolled hypertension (i.e., >160/100 mmHg despite adequate medical therapy); - Recent myocardial infarction, or history of congestive cardiac failure; - Any clinically significant neurological disorder; - Prior renal transplant, current renal dialysis, patients with creatinine clearance <30ml/min or history of renal tubular acidosis; - Severe hepatic impairment; - Fructose intolerance; - Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient’s ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the change in cough frequency in chronic cough patients after treatment with Memantine by assessing 24 hour cough recordings.;Secondary Objective: (i) To evaluate the change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) score after treatment with Memantine. (ii) To record the Global Rating of Change for cough frequency and severity after treatment with Memantine. ;Primary end point(s): Change from baseline in objectively recorded cough frequency in chronic cough patients after treatment with memantine.;Timepoint(s) of evaluation of this end point: This endpoint will be calculated from the baseline cough frequency (pre-treatment) and the cough frequency on the final day of 4 weeks treatment with the maximal tolerated dose of memantine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in cough specific quality of life Global Rating of Change Score;Timepoint(s) of evaluation of this end point: These endpoints will be calculated from the baseline measures (pre-treatment), those performed at prior to each increase in dose of therapy and on the final day of 4 weeks treatment with the maximal tolerated dose of memantine. | — |
Countries
United Kingdom
Contacts
Public ContactDr. Jacky Smith
University of Manchester
Outcome results
None listed