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The utility of feNO in the differential diagnosis of chronic cough

Phase 1
Conditions
Chronic cough is a common and poorly diagnosed condition. Younger patients tend to receive a diagnosis of asthma, whereas older patients are increasingly identified has having gastroesophageal reflux disease. Those patients presenting with upper airway symptoms are frequently labelled as having rhinitis. A considerable proportion of patients elude a diagnosis, either through testing or by the use of therapeutic trials and are then labelled as idiopathic cough.
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Registration Number
EUCTR2015-001736-38-GB
Lead Sponsor
Hull and East Yorkshire Hospitals NHS trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

•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=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 a normal FeNO treatment group)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

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
•Regular use of corticosteroids either as inhaled, topical or systemic = 4 weeks prior to enrolment
. 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
• Subjects with known allergy to prednisolone
•Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors.
•Current smoker

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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