Understanding chronic cough
| ISRCTN | ISRCTN65122210 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65122210 |
| Protocol serial number | Version 2.0 |
| Sponsor | University Hospitals South Manchester NHS Trust (UK) |
| Funder | Medical Resarch Council (MRC) (UK) (ref: G0900449) |
- 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
Scientific
North West Lung Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| emma.young@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Comparison of maximum cough responses between patient groups |
| Key secondary outcome measure(s) |
1. Comparison of cough threshold between patient groups |
| Completion date | 31/07/2010 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
North West Lung Research Centre
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/02/2017: No publications found in PubMed, verifying study status with principal investigator.
