EUCTR2015-001736-38-GB
Active, not recruiting
Phase 1
The utility of feNO in the differential diagnosis of chronic cough: The response to anti-inflammatory therapy with prednisolone and montelukast - The utility of feNO in the differential diagnosis of chronic cough
Hull and East Yorkshire Hospitals NHS trust0 sites50 target enrollmentSeptember 18, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hull and East Yorkshire Hospitals NHS trust
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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