The Utility of feNO in the Differential Diagnosis of Chronic Cough (TUF)

July 19, 2019 updated by: Hull University Teaching Hospitals NHS Trust

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • East Yorkshire
      • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
        • Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Montelukast (high FeNO)
Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take one tablet per day for 28 days Montelukast is a Class B medicine
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
Other Names:
  • Montelukast
Active Comparator: Prednisolone, Montelukast (high FeNO)
Prednisolone 5 mg and montelukast 10 mg. Patients to take Prednisolone 5 mg, 4 tablets per day for 14 days patients to take Montelukast 10 mg film-coated tablet per day for another 14 days Prednisolone is a Class A medicine Montelukast is a Class B medicine
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.
Other Names:
  • Prednisolone and Montelukast
Active Comparator: Montelukast
Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take one tablet per day for 28 days Montelukast is a Class B medicine
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
Other Names:
  • Montelukast

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hull Automated Cough counter
Time Frame: 28 days
To determine the difference in objective measure of cough as demonstrated by 24 hr cough counts at the baseline, after 2 and 4 weeks treatment between three treatment groups with an associated elevated FeNO.
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HARQ and LCQ questionnaires
Time Frame: 28 days
Compare change in subjective measures on HARQ and LCQ questionnaires of cough between the treatment groups at the baseline and after 2 week and 4 weeks treatment.
28 days
FVC as measured through spirometry
Time Frame: 28 days
Compare change in FVC between treatment groups at the baseline and after 2 weeks and 4 weeks treatment.
28 days
Cough Challenge
Time Frame: 28 days
Change in cough reflex sensitivity using inhaled citric acid between treatment groups at the baseline and after 2 weeks and 4 weeks treatment.
28 days
Sputum Induction
Time Frame: 28 days
Change in Sputum inflammatory markers between treatment groups at the baseline and after 2 weeks and 4 weeks treatment.
28 days
Blood Count
Time Frame: Baseline
Assess whether previous history of blood eosinophils may predict therapeutic response to anti-inflammatory medication in cough.
Baseline
FeNO measurement
Time Frame: 28 days
Assess whether the efficiency of FeNO may help to predict therapeutic response to anti-inflammatory medication in cough.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hull University Teaching Hospitals NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aerocrine AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alyn Morice, Professor, Head of Centre for Cardiovascular and Metabolic Studies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 9, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AcadMed1002015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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