Contact information
Type
Scientific
Primary contact
Prof Alyn Morice
ORCID ID
Contact details
Respiratory Medicine
Division Cardiovascular and Respiratory Studies
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
a.h.morice@hull.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AcadMed CTU04/05
Study information
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
Acronym
Study hypothesis
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
Hull and East Riding Local Research Ethics Committee approved on the 26th April 2006 (ref: 06/Q1104/46)
Study design
Randomised single centre crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
04/07/2006
Overall trial end date
19/10/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
04/07/2006
Recruitment end date
19/10/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Respiratory Medicine
Cottingham
HU16 5JQ
United Kingdom
Sponsor information
Organisation
Hull and East Yorkshire Hospitals NHS Trust (UK)
Sponsor details
Research and Development Office
Medical Research and Teaching Centre
Daisy Building
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
+44 (0)1482 461883
James.Illingworth@hey.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Hull and East Yorkshire Hospitals NHS Trust (UK) - Research and Development Grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20698995
Publication citations
-
Results
Wright CE, Jackson J, Thompson RL, Morice AH, Validation of the ERS standard citric acid cough challenge in healthy adult volunteers., Cough, 2010, 6, 8, doi: 10.1186/1745-9974-6-8.