The utility of feNO in the differential diagnosis of chronic cough
Research type
Research Study
Full title
The utility of feNO in the differential diagnosis of chronic cough: The response to anti-inflammatory therapy with prednisolone and montelukast
IRAS ID
178927
Contact name
Alyn Morice
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
Eudract number
2015-001736-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 26 days
Research summary
Chronic cough is a common and poorly diagnosed condition. Chronic cough is one of the commonest presenting complaints to secondary care. There are different causes of chronic cough the most common causes are asthma, post nasal drip and gastro-oesophageal reflux. However it is really difficult to diagnose the cause of cough to apply the right medicines.
The crucial question in the management of a patient with a chronic cough is whether the cause of cough is reflux or not, leads to inflammation within the airways.
It is our hypothesis that fractional exhaled nitric oxide (FeNO), measured at presentation, will allow the clinician to decide whether patients would be more appropriately treated by anti-inflammatory therapy or other options should be administered first line. In this study we only testing anti-inflammatory therapy to see weather FeNO is able to predict therapeutic response to the anti-inflammatory therapy.In this study forty patients with high feNO values (≥30ppm) will be randomised in an open label fashion to receive either montelukast 10 mg for four weeks(n=20) or prednisolone 20 mg for two weeks followed by montelukast 10 mg for another two weeks(n=20). From the remaining patients a group of 20 patients with normal feNO values (≤20 ppm) will receive montelukast 10 mg for four weeks.
Patient demographics, baseline spirometry, FeNO measurement, full blood count and concomitant medication will be collected as part of the routine clinic protocol. Patients will have further tests outside their standard medical care including, sputum induction, cough challenge, 24hr cough count, completion of Leicester cough questionnaire and Hull Airways Reflux Questionnaire (HARQ) at the screening visit. All these tests will be repeated at 2nd and 4th weeks of treatment.If successful this protocol will demonstrate the efficacy of feNO in predicting therapeutic response to anti inflammatory medication in cough.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0251
Date of REC Opinion
26 Aug 2015
REC opinion
Further Information Favourable Opinion