Plain English Summary
Background and study aims
People cough in order to clear their airways. Most coughs are caused by viruses and settle down by themselves, but some people develop persistent coughing which can last for many years. This is called chronic cough. People with chronic cough find the symptom very upsetting and it can have a major impact on their quality of life. There are currently no effective treatments for chronic cough. This study aims to investigate whether a drug called Memantine helps to reduces coughing. Memantine is a similar medication to that found in many over the counter treatments for cough (Dextromethorphan). Memantine is currently licensed to treat patients with Alzheimer’s disease. It has never been tested on patients with chronic cough.
Who can participate?
People aged 18 - 90 with chronic cough.
What does the study involve?
Fifteen patients attending the specialist chronic cough service at Wythenshawe Hospital will be invited to attend the North West Lung Research Centre up to 7 times over a maximum 8-week period. During the course of the study they will be asked to take increasing doses of Memantine, have a blood test, electrocardiogram (recording the electrical activity of the heart), undergo 24-hour cough monitoring, and answer cough-related questionnaires.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
North West Lung Research Centre at Wythenshawe Hospital (UK).
When is the study starting and how long is it expected to run for?
September 2012 to March 2013.
Who is funding the study?
Medical Research Council (UK).
Who is the main contact?
Danielle Yuill
danielle.yuill@manchester.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Miss Danielle Yuill
ORCID ID
Contact details
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
-
danielle.yuill@manchester.ac.uk
Additional identifiers
EudraCT number
2011-005151-13
ClinicalTrials.gov number
Protocol/serial number
12508
Study information
Scientific title
Open-label pilot study of memantine in chronic cough patients attending a specialist clinic
Acronym
Study hypothesis
This study aims to investigate whether a drug called Memantine helps to reduces coughing.
More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12508
Ethics approval
NRES Committee North West - Haydock, 20/12/2011 ref: 11/NW/0840
Study design
Non-randomised interventional trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic cough
Intervention
Memantine, escalating dose from 10 mg/day to 40 mg/day
Intervention type
Drug
Phase
Not Applicable
Drug names
Memantine
Primary outcome measure
To evaluate the change in objectively recorded cough frequency in chronic cough patients after treatment
Secondary outcome measures
No secondary outcome measures
Overall trial start date
03/09/2012
Overall trial end date
01/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Chronic cough (>8 weeks)
2. Normal chest x-ray
3. FEV1 and FVC >70% predicted measured using spirometry
4. 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)
5. Females will be non-pregnant and non-lactating with no intention of pregnancy during study treatment
6. Male and female participants aged 18 - 90 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 15
Participant exclusion criteria
1. Recent upper respiratory tract infection (<4 weeks)
2. Pregnancy/breastfeeding. Women of childbearing potential (not >2 years postmenopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test, performed at visit 1 prior to administration of study medication
3. Current smokers or ex-smokers with <6 months abstinence or cumulative history of >10 pack years
4. Current treatment with ACE inhibitors
5. Drug or alcohol abuse
6. Uncontrolled hypertension (i.e., >140/90 mmHg despite adequate medical therapy)
7. Recent myocardial infarction, or history of congestive cardiac failure
8. Any clinically significant neurological disorder
9. Prior renal transplant, current renal dialysis, patients with creatinine clearance <30ml/min or history of renal tubular acidosis
10. Severe hepatic impairment
11. Fructose intolerance
12. Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study
Recruitment start date
03/09/2012
Recruitment end date
01/03/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
University Hospital of South Manchester (UK)
Sponsor details
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
Medical Research Council [MRC] ref: G0701918 (UK) ID #87018
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list