Open-label pilot study of memantine in chronic cough patients attending a specialist clinic

ISRCTN ISRCTN99941214
DOI https://doi.org/10.1186/ISRCTN99941214
EudraCT/CTIS number 2011-005151-13
Secondary identifying numbers 12508
Submission date
05/09/2012
Registration date
10/09/2012
Last edited
23/06/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Miss Danielle Yuill
Scientific

Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Email danielle.yuill@manchester.ac.uk

Study information

Study designNon-randomised interventional trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOpen-label pilot study of memantine in chronic cough patients attending a specialist clinic
Study objectivesThis 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(s)NRES Committee North West - Haydock, 20/12/2011 ref: 11/NW/0840
Health condition(s) or problem(s) studiedChronic cough
InterventionMemantine, escalating dose from 10 mg/day to 40 mg/day
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Memantine
Primary outcome measureTo evaluate the change in objectively recorded cough frequency in chronic cough patients after treatment
Secondary outcome measuresNo secondary outcome measures
Overall study start date03/09/2012
Completion date01/03/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit90 Years
SexBoth
Target number of participantsUK Sample Size: 15
Total final enrolment14
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment03/09/2012
Date of final enrolment01/03/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom

Sponsor information

University Hospital of South Manchester (UK)
Hospital/treatment centre

Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
United Kingdom

Website http://www.uhsm.nhs.uk/
ROR logo "ROR" https://ror.org/00he80998

Funders

Funder type

Research council

Medical Research Council [MRC] ref: G0701918 (UK) ID #87018
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 23/06/2020 No No
HRA research summary 28/06/2023 No No

Editorial Notes

23/06/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
07/12/2017: No publications found in PubMed, verifying study status with principal investigator.