Evaluation of FeNO for predicting response to inhaled corticosteroids
Research type
Research Study
Full title
The evaluation of FeNO for predicting response to an inhaled corticosteroid in subjects with non-specific respiratory symptoms
IRAS ID
149005
Contact name
David Price
Contact email
Sponsor organisation
Research in Real Life Ltd.
Eudract number
2014-000051-90
Research summary
The majority of asthma cases is characterised by inflammation of the airway mucosa which is measurable by the fraction of exhaled Nitric Oxide (FeNO). This type of asthma can most effectively be treated by inhalation of corticosteroids (ICS).
In clinical practice, FeNO can aid confirmation of an asthma diagnosis and can indicate the degree of steroid-responsiveness. This can help guide physician decisions on the initiation or adjustment of ICS therapy. Therefore, FeNO measurement could be particularly useful to confirm an asthma diagnosis in patients with non-specific respiratory symptoms (≥ 6 weeks of cough and/or wheezing and/or chronic dyspnoea) and to assess how likely they are to benefit from ICS treatment.
We aim at enrolling 290 patients in approximately 30 clinics in the UK and Singapore. Patients presenting to their GP with symptoms suggestive of non-specific respiratory symptoms, will be classified into a normal, intermediate and high FeNO group. After two weeks they will return to the practice to assess whether their symptoms are persistent. If their eligibility is determined they will be randomised to the treatment or control group according to their baseline FeNO level. The treatment group will undergo a 6-week long treatment with the ICS Qvar Easi Breathe, while the control group will be using a placebo inhaler. After 6 weeks the FeNO groups will be compared in their response to the ICS treatment.
This study will be conducted by Research in Real Life (Cambridge, UK) with partial funding from Aerocrine. The estimated total duration of the study is 14 months and each patient will spend 8 weeks in the study.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
14/YH/0129
Date of REC Opinion
1 May 2014
REC opinion
Favourable Opinion