Ignite Creation Date:
2024-05-06 @ 7:07 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02479074
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2015-06-16
Brief Title:
The Utility of feNO in the Differential Diagnosis of Chronic Cough
Sponsor:
Hull University Teaching Hospitals NHS Trust
Organization:
Hull University Teaching Hospitals NHS Trust
Study Overview
Official Title:
The Utility of feNO in the Differential Diagnosis of Chronic Cough The Response to Anti-inflammatory Therapy With Prednisolone and Montelukast
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TUF
Brief 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 FeNO30 ppb will be enrolled in to the High FeNO Treatment Groups They will be randomised on a 11 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 FeNO20 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 registrarconsultant as per the standard care as a clinic patient
40 patients with chronic cough and a FeNO30 ppb will be enrolled in to the High FeNO Treatment Groups They will be randomised on a 11 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 FeNO20 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 registrarconsultant as per the standard care as a clinic patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None