The Utility of feNO in the Differential Diagnosis of Chronic Cough

• Status: Completed
• Trial end date: 2017-03-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust; Hull University Teaching Hospitals NHS Trust
• Collaborator: Aerocrine AB
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Montelukast; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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