The Evaluation of FeNO for Predicting Response to ICS in Subjects With Non-specific Respiratory Symptoms
Condition: Asthma
MeSH terms: Signs and Symptoms, Respiratory
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Qvar (100 mcg)
Intervention type(s): Drug
Intervention description(s): 2 puffs twice daily; 400 mcg daily over 4 weeks treatment period
Other intervention name(s): Beclomethasone diproprionate
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cough, wheeze, dyspnoea