Diffuse noxious inhibitory controls in chronic cough
| ISRCTN | ISRCTN31901405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31901405 |
| Protocol serial number | DNIC1; G0900449 |
| Sponsor | University Hospitals of South Manchester NHS Foundation Trust (UK) |
| Funder | Medical Research Council (MRC) (UK) (ref: 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
Scientific
University Hospitals South Manchester
North West Lung Research Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom
| emma.young@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised four-way cross-over study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Effect of conscious cough suppression on cough response |
| Completion date | 04/01/2012 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| 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
- United Kingdom
- England
Study participating centre
University Hospitals South Manchester
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
13/02/2017: No publications found, verifying study status with principal investigator.
