Understanding chronic cough

ISRCTN	ISRCTN65122210
DOI	https://doi.org/10.1186/ISRCTN65122210
Secondary identifying numbers	Version 2.0

Submission date: 16/03/2011
Registration date: 07/04/2011
Last edited: 08/02/2017

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

North West Lung Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Email	emma.young@manchester.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Comparing Capsaicin Dose-Response Curves
Study acronym	DRC
Study objectives	The shape of capsaicin dose-response curves differ: 1. In healthy volunteers, asthmatics and patients with chronic cough 2. In men and women These differences may provide insights into important mechanisms that lead to excessive coughing.
Ethics approval(s)	North West 7 Research Ethics Committee - Greater Manchester Central approved 19/10/2010
Health condition(s) or problem(s) studied	Chronic cough
Intervention	Two capsaicin cough challenge tests performed: 1. Increasing doses are inhaled up to maximum tolerated dose 2. Doses are inhaled in a random order 3. Number of coughs and urge-to-cough intensity recorded
Intervention type	Other
Primary outcome measure	Comparison of maximum cough responses between patient groups
Secondary outcome measures	1. Comparison of cough threshold between patient groups 2. Comparison of urge-to-cough threshold between patient groups 3. Comparison of maximum cough responses and cough threshold in men and women
Overall study start date	01/11/2009
Completion date	31/07/2010

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Key inclusion criteria	Healthy volunteers 1. Over 18 years old 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 Asthmatics 1. Over 18 years old 2. Physician diagnosis of asthma 3. Objective evidence of bronchial hyper-reactivity (either positive bronchial provocation test or significant (>12%) reversibility in FEV1 following inhaled bronchodilator) 4. Stable asthma [forced expiratory volume in one second (FEV1) > 75% predicted, no acute exacerbations requiring oral corticosteroids within last 4 weeks] 5. Can safely omit long-acting bronchodilators (if taking) Chronic Cough Patients 1. Over 18 years old 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	All participants: 1. Recent upper respiratory tract infection (< 4weeks) 2. Pregnancy or breast-feeding 3. Use of agiotensin 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 > 10 pack year smoking history
Date of first enrolment	01/11/2009
Date of final enrolment	31/07/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

North West Lung Research Centre

Manchester
M23 9LT
United Kingdom

Sponsor information

University Hospitals South Manchester NHS Trust (UK)
Not defined

c/o Andrew Maines
Research and Development
Education and Research Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom

Email	andrew.maines@manchester.ac.uk
"ROR"	https://ror.org/00he80998

Funders

Funder type

Research council

Medical Resarch Council (MRC) (UK) (ref: G0900449)

No information available

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

08/02/2017: No publications found in PubMed, verifying study status with principal investigator.