NCT02479074

The Utility of feNO in the Differential Diagnosis of Chronic Cough

The Utility of feNO in the Differential Diagnosis of Chronic Cough: The Response to Anti-inflammatory Therapy With Prednisolone and Montelukast

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Hull University Teaching Hospitals NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study the investigators wish to explore the difference in 24 hr. cough counts measured using the Hull Automated Cough Counter (HACC), from baseline and after two weeks treatment with either montelukast or prednisolone in patients with an NO measurement of ≥30 ppb at screening.

Detailed description

Patients attending the unit as part of their normal outpatients' appointment will be approached with regards to whether interested in taking part in the study. During an outpatients appointment all new chronic cough patients undertake Demographics assessment, full blood count, spirometry test, FeNO measurement and concomitant medication as part of their standard medical care. If a patient decides to take part in this study then at this visit they will have further tests outside their standard medical care including, sputum induction, completion of Leicester cough questionnaire, cough challenge and 24 hr cough monitoring at the screening visit. All the data collected in terms of the clinic visit and additional tests will be analysed in this study. 40 patients with chronic cough and a FeNO≥30 ppb will be enrolled in to the High FeNO Treatment Groups. They will be randomised on a 1:1 ratio to receive either: Montelukast 10 mg daily for four weeks or Prednisolone 20 mg daily for two weeks followed by two weeks Montelukast 10 mg. 20 subjects with chronic cough and a FeNO≤20 ppb will be enrolled in low FeNO Treatment Group will receive montelukast 10 mg for 28 days. The study consists of five visits to the unit. The first visit will be combined with the patients scheduled clinic appointment. During this visit the investigators will carry out some preliminary assessments such as checking medical history, physical examination, full blood count and vital signs. Demographics assessments, spirometry test, FeNO measurement and concomitant medication will be recorded as per their scheduled clinic visit. Further testing will be conducted with regards to the study, these tests include: sputum induction, cough challenge, Hull Airways Reflux Questionnaire (HARQ), Leicester Cough Questionnaire (LCQ) and 24h cough monitoring all these tests will be operated at baseline and after 2 weeks and 4 weeks treatment. Also pregnancy test for women of child bearing potential is required in this study. At the end of visit 1, patients will receive 14 or 28 days' supply of the randomised study medication. Visit 2 (13th day) and visit 4 (27th day): Participants will be asked to come to the unit where The Hull Automated Cough Counter will be applied to measure their cough frequency for 24 hours at the end of their treatment. Visit 3 (14th day) and visit 5 (28th day): Patients will be assessed for any adverse events and any changes in concomitant medication use during the trial and also their vital signs will be checked. After that the FeNo measurement, Pulmonary Function Tests, cough challenge, sputum induction, 24h cough monitoring, Hull Airways Reflux Questionnaire (HARQ) and Leicester Cough Questionnaire (LCQ) will be repeated to compare with the first assessment. At the end of the study all patients will be reviewed by a chronic cough registrar/consultant as per the standard care as a clinic patient.

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	Montelukast (High FeNO group)	Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take (oral use) one tablet per day for 28 days
DRUG	Prednisolon, Montelukast (High FeNO)	Prednisolone 5 mg, patients to take 4 tablets per day for 14 days then take Montelukast 10 mg tablet per day for another 14 days.
DRUG	Montelukast (Low FeNO group)	Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take one tablet per day for 28 days

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-02-10
• Completion: 2017-03-09
• First posted: 2015-06-23
• Last updated: 2019-07-23

Locations

1 site across 1 country: United Kingdom