Does a low Exhaled Nitric Oxide level exclude a clinical benefit from inhaled corticosteroids in suspected asthma; a randomised, placebo controlled trial.
Phase 1
- Conditions
- suspected asthma people with asthma like symptomsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-000338-23-GB
- Lead Sponsor
- niversity of Nottingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 165
Inclusion Criteria
Aged 18 years or over.
Asthma suspected by GP / Practice Nurse
Low Exhaled Nitric Oxide reading <27ppb
Must be able to give informed consent freely
FEV1 >70% predicted
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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
Exclusion Criteria
Patients requiring oral steroid treatment on visit to GP/Practice nurse
Use of oral prednisolone or antibiotics within last 4 weeks
Already using an inhaled corticosteroid
Any other clinically significant co-morbidity inc., bronchiectasis, COPD
Expectant or breast-feeding mothers
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method