The Utility of feNO in the Differential Diagnosis of Chronic Cough
The Utility of feNO in the Differential Diagnosis of Chronic Cough
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.
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.
Inclusion Criteria:

 -  Patients with a history of chronic cough (at least 8 weeks duration)

 -  Male and female subjects of at least 18 yrs of age

 -  Subjects able to understand the study and co-operate with the study procedures

 -  Subjects who consent to their general practitioner (GP) being informed of their study
 participation.

 -  Patients with a FeNO of ≥30ppb at presentation to the Chronic cough clinic.( required
 for entry on to the high FeNO treatment groups)

 -  Patients with FeNO ≤ 20 ppb at presentation to the chronic cough clinic (required for
 entry as low FeNO treatment group)

 Exclusion Criteria:

 -  Patients with current diagnosis of asthma.

 -  Female subjects who are pregnant, or lactating, or who are of child bearing potential
 but are not using contraceptive measures.

 -  Suffering from any concomitant disease (chronic heart, chronic lung such as; COPD,
 bronchiectasis and cystic fibrosis, chronic renal, chronic liver or neuromuscular
 disease or immunosuppression; pneumonia and diabetes) which may interfere with study
 procedures or evaluation.

 -  A lower respiratory tract infection 4 weeks prior to entry on to study

 -  Systemic infections

 -  Live virus immunisation planned within next 3 months

 -  Subjects with no previous chickenpox who had a recent (<=28 days) close personal
 contact with chickenpox OR herpes zoster (high FeNO treatment groups only)

 -  Subjects having recent (<=28 days) exposure to measles (high FeNO treatment groups
 only)

 -  Participation in another study (use of investigational product) within 30 days
 preceding entry on to study.

 -  Alcohol or drug abuse

 -  Inability to follow study procedures

 -  Use of corticosteroids either as inhaled, topical or systemic ≥ 4weeks prior to
 enrolment

 -  Subjects with known allergy to prednisolone, montelukast

 -  Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors.

 -  Current smoker

 -  Subjects who are taking bronchodilators should be on it for at least 4 weeks on
 regular dose and carry on the same dose during the study