Condition category
Respiratory
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
Coughing is extremely common and has a major impact on quality of life. Some people develop persistent coughing (more than 8 weeks in duration) which is called chronic cough. The current treatments for chronic cough are not effective. To develop better treatments we would like to understand how coughing can normally be controlled in healthy people. Coughing can be induced by breathing in an extract of chilli pepper (called capsaicin). This is entirely safe, and has been used in several research studies. Our previous research has shown that healthy people tend to cough much less than patients with a cough after they have inhaled capsaicin, but we do not yet understand why this is. We believe that when healthy people inhale capsaicin, morphine-like substances may be released in the brain. These morphine-like substances may reduce coughing by acting on certain brain receptors, known as opiate receptors. We think that by blocking these opiate receptors using a drug called naltrexone, healthy people would temporarily cough more than usual.

Who can participate?
We will need 15 male healthy volunteers to take part in this study.

What does the study involve?
The study will involve two visits at least 1 week apart. Each visit will last about 2 hours. At one of the visits, the volunteer will take a tablet containing naltrexone, and at the other visit the volunteer will take a tablet that contains no active drug (called a placebo). The study doctor will not know which tablet the volunteer takes during the study visits (known as blinding). During each visit the volunteer will inhale capsaicin so that we can measure how much they cough and be asked to complete a questionnaire about their urge to cough.

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?
August 2012 to April 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

ClinicalTrials.gov number

Protocol/serial number

12506

Study information

Scientific title

The effect of Naltrexone, an Opiate Receptor Antagonist, on capsaicin dose-response in male Healthy volunteers (NORAH)

Acronym

NORAH

Study hypothesis

Coughing is extremely common and has a major impact on quality of life. Some people develop persistent coughing (more than 8 weeks in duration) which is called chronic cough. Current treatments for chronic cough are ineffective. To develop better treatments we would like to understand how coughing can normally be controlled in healthy people. Coughing can be induced by breathing in an extract of chilli pepper (called capsaicin). This is entirely safe, and has been used in several research studies. Our previous research has shown that healthy people tend to cough much less than patients with a cough after they have inhaled capsaicin, but we do not yet understand why this is. We believe that when healthy people inhale capsaicin, morphine-like substances may be released in the brain. These morphine-like substances may reduce coughing by acting on certain brain receptors, known as opiate receptors. We think that by blocking these opiate receptors using a drug called naltrexone, healthy people would temporarily cough more than usual.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12506

Ethics approval

NRES Committee North West - Greater Manchester South, 21/05/2012 ref: 12/NW/0293

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

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

Naltrexone, 50 mg naltrexone tablet or placebo administered to volunteers

Intervention type

Drug

Phase

Not Applicable

Drug names

Naltrexone

Primary outcome measures

Effect of naltrexone compared to placebo on maximal capsaicin-induced cough frequency

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/08/2012

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male
2. Aged 18 - 75 years old
3. Normal lung function
4. No current or past history of chronic cough or chronic respiratory illness
5. No current or past history of chronic pain, irritable bowel syndrome or chronic headaches
6. No current or past history of psychiatric illness
7. No current history of reflux disease or post-nasal drip syndrome

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

UK Sample Size: 20

Participant exclusion criteria

1. Age >75 years
2. Recent upper respiratory tract infection (<4weeks)
3. Use of ACE inhibitors
4. Use of centrally acting medications that may affect the cough reflex
5. History of drug or alcohol abuse
6. Current smoker or ex-smoker with >10 pack year smoking history
7. A previous or current history of liver disease
8. Dependency on opioids
9. Current use of opiates
10. Known hypersensitivity to naltrexone

Recruitment start date

01/08/2012

Recruitment end date

01/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

South Manchester University Hospital (UK)

Sponsor details

Wythenshawe Hospital
Southmoor Road
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] (UK) ref: G0900449

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