A longitudinal study of patients with unexplained chronic cough(UCCLS)
Research type
Research Study
Full title
A longitudinal prospective study to measure biomarkers from blood, urine and airway samples from patients with unexplained chronic cough and healthy volunteers.
IRAS ID
203709
Contact name
Ian Pavord
Contact email
Sponsor organisation
Clinical Trials and Research Governance, University of Oxford
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
In up to 40% of patients, chronic cough remains unexplained despite extensive investigations and treatment trials and pathogenetic mechanisms driving this condition are still not fully understood . Also, it is not ideal that unexplained chronic cough (UCC) remains a diagnosis of exclusion with no better way of identifying these patients. There have been no other previous studies undertaken to discover novel biomarkers in UCC nor performed sequential temporal assessments on a longitudinal basis in relation to clinical measures of disease behaviour in UCC patients.
This will be a longitudinal prospective study of exploratory nature, conducted at a single centre, involving a total of 200 participants with UCC and healthy volunteers. Samples from blood, urine and airway from all participants will be used to discover biomarkers of interest and prospectively validated for future use in clinical studies and to study disease behaviour in participants with UCC. Tissue from healthy volunteers will be used for comparisons to ensure that all observations in participants with UCC are disease-specific.
The entire duration of this research study is 5 years. All study procedures and/or tests performed in this study would be used to provide a full profile of the individual participant's cough.
With valid informed consent in place, healthy volunteers who had been recruited through advertisements, will be invited to attend a minimum of 4 visits at the clinic/hospital over a period of 16 days.
With valid informed consent in place, patient participants, who had been recruited through the respiratory clinic at Churchill Hospital, will be invited to attend a minimum of 4 visits at the clinic/hospital over an initial period of 16 days. Subsequently, these patient participants will be invited back yearly for mandatory repeat assessments for the 5-year duration of this research study. These yearly assessments will usually involve a minimum of 3 visits over 9 days each year. If it were found that their chronic cough had resolved during these yearly assessments, patient participants will be invited to undergo an additional repeat bronchoscopy during that year.REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0450
Date of REC Opinion
26 Oct 2016
REC opinion
Further Information Favourable Opinion