Citric acid cough challenge validation
| ISRCTN | ISRCTN98385033 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98385033 |
| Protocol serial number | AcadMed CTU04/05 |
| Sponsor | Hull and East Yorkshire Hospitals NHS Trust (UK) |
| Funder | Hull and East Yorkshire Hospitals NHS Trust (UK) - Research and Development Grant |
- Submission date
- 05/06/2009
- Registration date
- 18/09/2009
- Last edited
- 25/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Respiratory Medicine
Division Cardiovascular and Respiratory Studies
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
| a.h.morice@hull.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single centre crossover study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Validation of the citric acid cough challenge using the KoKo DigiDoser system in healthy volunteers: a 4-week randomised single centre crossover study |
| Study objectives | The citric acid cough challenge was first reported in humans over 50 years ago. The test was established to allow for the quantification of cough and also as a tool for the assessment of antitussive properties of certain therapies. Since this time many different protocols have been published to measure cough reflex sensitivity these can vary in terms of the nebuliser used, tussive agent, single breath, single dose, dose response and number of coughs required to attain a threshold. In our opinion a definitive method for measuring cough sensitivity needs to be established to allow for standardisation of results from different groups to be compared. The standardisation of this test will lead to a higher quality of research, better drug development and ultimately better patient care. |
| Ethics approval(s) | Hull and East Riding Local Research Ethics Committee approved on the 26th April 2006 (ref: 06/Q1104/46) |
| Health condition(s) or problem(s) studied | Artificially induced cough |
| Intervention | Volunteers were randomised for the order methods to induce artificial cough, i.e., whether the Mefar dosimeter was used first or the KoKo DigiDoser. The following assessments were then performed: 1. Impulse oscillometry 2. Spirometry 3. Citric acid cough challenge |
| Intervention type | Other |
| Primary outcome measure(s) |
Reproducibility of cough reflex sensitivity to citric acid (measured via inhalation of incremental, doubling concentrations of citric acid until the concentration inducing two or more coughs or five or more coughs is reached)using the modified Devilbiss 646 nebuliser powered by the KoKo DigiDoser. Measured within 1 day comparing baseline challenge and challenges at 1, 2 and 4 hours post-baseline to measure within-day reproducibility. |
| Key secondary outcome measure(s) |
To compare the reproducibility of cough reflex sensitivity using the modified Devilbiss 646 nebuliser powered by the KoKo DigiDoser with that of the more commonly used MB2 nebuliser powered by the MB3 mefar dosimeter. Assessed at baseline and then two weeks later to assess between-day reproducibility. |
| Completion date | 19/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Healthy male/female volunteers 2. Male and female subjects of at least 18 years of age 3. Non-smokers or, ex-smokers of at least 12 months 4. Forced expiratory volume in one second (FEV1) greater than 80% of predicted |
| Key exclusion criteria | 1. Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures 2. Suffering from any active seasonal allergies 3. Suffering from concomitant disease which may interfere with study procedures or evaluation. 4. Subjects suffering from gastroesophageal reflux taking proton pump inhibitors or any other regular antacid therapy 5. Subjects suffering from post nasal drip syndrome 6. A recent respiratory tract infection within 6 weeks prior to entry on to study 7. Use of medications known to alter the cough reflex 8. Smoking history of greater than 10 pack years |
| Date of first enrolment | 04/07/2006 |
| Date of final enrolment | 19/10/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
HU16 5JQ
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? |
|---|---|---|---|---|---|
| Results article | results | 10/08/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
