Asthma Clinical Trial
Official title:
The Evaluation of FeNO for Predicting Response to an Inhaled Corticosteroid in Subjects With Non-specific Respiratory Symptoms
Nitric Oxide is recognized as a biological marker for many chronic airway diseases. It has
been standardised for clinical use indicating airway inflammation.
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
of inhaled corticosteroid (ICS) therapy, 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 corticosteroid
treatment.
This study will assess the suitability of FeNO to predict ICS responsiveness in patients
with non-specific respiratory symptoms.
Additionally, we would like to determine the suitability of FeNO as a diagnostic tool for
asthma in comparison to conventional predictors, e.g. spirometry.
Randomised, double-blind, placebo-controlled trial with planned enrolment of 264 patients
from the UK and Singapore. Eligible patients are 18-80 years old with ≥6 weeks' duration of
non-specific respiratory symptoms defined as cough and/or wheeze and/or dyspnoea. Patients
with FEV1 <90% predicted at visit 1 must show reversibility of <20% at visit 1 or within the
prior year. Key exclusion criteria are prior diagnosis of asthma; evidence of concomitant
chronic respiratory disease, respiratory tract infection; or known significant risk factor
for cough or wheeze.
Baseline assessments will include spirometry (FEV1, forced vital capacity) and FeNO
measurement. Patients will be provided with a peak flow meter for twice daily measurement
throughout the study. At 2 weeks, a clinical assessment and spirometry will be performed to
confirm eligibility, and patients will complete four validated questionnaires to assess
quality of life, asthma control, and asthma symptoms, including a visual analog scale for
bother from asthma symptoms. Eligible patients will then be stratified by baseline FeNO
level (normal ≤25, intermediate >25 to ≤50, or high >50 ppb); each group will be randomised
to receive beclometasone 400 mcg daily or placebo for 6 weeks. An optional blood sample will
be collected from consenting patients to assess blood eosinophils.
At visit 3, final assessments will include spirometry, FeNO measurement, and all
questionnaires. Interaction analysis will be used to determine whether a differential effect
exists in response to ICS between FeNO groups.
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