Condition category
Signs and Symptoms
Date applied
05/09/2012
Date assigned
10/09/2012
Last edited
27/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.uhsm.nhs.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council [MRC] ref: G0701918 (UK) ID #87018

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes