Diffuse noxious inhibitory controls in chronic cough

ISRCTN	ISRCTN31901405
DOI	https://doi.org/10.1186/ISRCTN31901405
Secondary identifying numbers	DNIC1; G0900449

Submission date: 20/12/2010
Registration date: 07/04/2011
Last edited: 13/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Emma Young
Scientific

University Hospitals South Manchester
North West Lung Research Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom

Email	emma.young@manchester.ac.uk

Study information

Study design	Randomised four-way cross-over study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Diffuse Noxious Inhibitory Controls in chronic cough: a randomised, four-way cross-over study of 20 healthy subjects and 20 patients with chronic cough
Study acronym	DNIC
Study objectives	1. Inhibitory mechanisms control coughing in healthy subjects, but not in patients with chronic cough 2. Females have less effective inhibitory mechanisms compared to males
Ethics approval(s)	North West 6 Research Ethics Committee - Greater Manchester South, 14/12/2010, ref: 10/H1003/104
Health condition(s) or problem(s) studied	Chronic cough
Intervention	Basal conditions: During both blocks of capsaicin inhalation (block 1 and block 2) participants will not place their hand in a water bath and will be instructed to cough freely. Control conditions: During both blocks of capsaicin inhalation (block 1 and block 2) participants will place their hand in a non-painful warm water bath (37°C) and will be instructed to cough freely. Cold water conditions: During one of the blocks of capsaicin inhalation (block 1 or 2) participants will place their hand in a painful cold water bath (10°C). During the other block participants will place their hand in a non-painful warm water bath (37°C). The order of the blocks is randomised. Participants will cough freely throughout. Conscious cough suppression conditions: During one of the blocks (block 1 or 2) participants will place their hand in a non-painful warm water bath (37°C) and will be asked to "try not to cough". During the other block participants will place their hand in a non-painful warm water bath (37°C) and will be instructed to cough freely. The order of the blocks is randomised. The duration of this clinical trial will range from 2 - 5 weeks.
Intervention type	Other
Primary outcome measure	Effect of painful cold water bath on cough response, recorded following each of the four randomised interventions. Each intervention will take place at least 48 hours apart.
Secondary outcome measures	1. Effect of conscious cough suppression on cough response 2. Comparison of effects by group and gender The primary and secondary outcome measures will be recorded following each of the four randomised interventions. Each intervention will take place at least 48 hours apart.
Overall study start date	04/01/2011
Completion date	04/01/2012

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40 (20 healthy volunteers and 20 chronic cough patients)
Key inclusion criteria	Healthy volunteers: 1. Aged over 18 years old, either sex 2. Normal lung function 3. No current or past history of chronic cough or chronic respiratory illness 4. No current or past history of chronic pain, irritable bowel syndrome or chronic headaches 5. No current or past history of psychiatric illness 6. No current history of reflux disease or post-nasal drip syndrome Chronic cough patients: 1. Aged over 18 years old, either sex 2. Chronic cough, defined as a cough lasting longer than 8 weeks despite investigation and/or treatment trials for cough variant asthma, post-nasal drip and gastro-oesophageal reflux disease 3. Normal chest x-ray 4. Normal lung function 5. Can safely omit long-acting bronchodilators (if taking)
Key exclusion criteria	1. Recent upper respiratory tract infection (less than 4 weeks) 2. Pregnancy or breastfeeding 3. Use of angiotensin converting enzyme (ACE) inhibitors 4. Any centrally acting medication which could alter the sensitivity of the cough reflex 5. History of drug or alcohol abuse 6. Current smoker or ex-smoker with greater than 10 pack year smoking history
Date of first enrolment	04/01/2011
Date of final enrolment	04/01/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University Hospitals South Manchester

Manchester
M23 9LT
United Kingdom

Sponsor information

University Hospitals of South Manchester NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Dr Andrew Maines
Ground Floor, Education & Research Centre
Southmoor Road
Manchester
M23 9LT
England
United Kingdom

Email	andrew.maines@manchester.ac.uk
Website	http://www.uhsm.nhs.uk/Pages/default.aspx
"ROR"	https://ror.org/00he80998

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G0900449)
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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

13/02/2017: No publications found, verifying study status with principal investigator.