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Clinical Trials/EUCTR2015-001736-38-GB
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.

Registry
who.int
Start Date
September 18, 2015
End Date
March 9, 2017
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Hull and East Yorkshire Hospitals NHS trust

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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