Improvement of FeNO and FEF25-75 After Inhaled Corticosteroid Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Abnormal lung function and high exhaled nitric oxide (FeNO) have been reported in
      asymptomatic patients with asthma. The investigators aimed to assess whether FeNO and
      FEF25-75 improve concurrently after treatment with inhaled corticosteroid (ICS) in patients
      with controlled asthma. Geometric mean (GM) FeNO and spirometric values in patients 8 to 16
      years of age who maintained asthma control without controller medication were compared with
      healthy controls and patients with uncontrolled asthma who were also not receiving controller
      medications. Patients with controlled asthma and high FeNO (> 25 ppb) were randomized to ICS
      treatment or to remain untreated. Changes in spirometric values and GM FeNO from baseline
      were evaluated after 6 weeks.
    

Detailed description: 
      Current guideline-defined asthma control cannot be applied to the level of airway
      inflammation because neither symptoms nor the results of basic pulmonary function tests can
      reflect ongoing airway inflammation.Consequently, asymptomatic or minimally symptomatic
      patients are usually considered to have controlled asthma even if they have subclinical
      airway inflammation. Measures of airway inflammation are thus required to identify patients
      with silent airway inflammation which does not manifest itself as symptoms or impaired lung
      function. In addition, measurement should be easy to perform, reproducible, and associated
      with a high degree of acceptance by patients. In this regard, the advent of FeNO measurements
      represents a significant advance in monitoring airway inflammation of asthmatic patients.
      High FeNO values above certain cut-point may indicate active eosinophilic airway inflammation
      and the likelihood of deterioration in asthma control. However, it is still unclear that high
      FeNO in asymptomatic patients implies the need for the anti-inflammatory treatment.

      Current guidelines for asthma management recommended forced expiratory volume in the first
      second (FEV1) as a principle spirometric parameter to assess airflow limitation. However,
      asthmatic subjects have air trapping in the presence of normal FEV1. Air trapping in
      asthmatic subjects has been demonstrated to be better correlated with forced expiratory flow
      between 25% and 75% of vital capacity % predicted (FEF25-75 % predicted) than FEV1 %
      predicted. In fact, impaired FEF25-75 is one of the most common abnormalities in pulmonary
      function in cross-sectional studies in asymptomatic patients. In addition, high FeNO in
      asymptomatic or minimally symptomatic patients may be accompanied by impairment of FEF25-75
      because both parameters have been suggested to be measures of residual small airway disease.
      Therefore, there is a possibility that the improvement of FEF25-75 happens concomitantly with
      the decrease of FeNO during the anti-inflammatory treatment. In this study, we recruited
      previously well-documented atopic asthmatic children who required no medication to maintain
      asthma control for more than 3 months and had high FeNO levels (> 25 ppb). We aimed to assess
      whether the decrease of FeNO occurs simultaneously with improvement of FEF25-75 after
      treatment with inhaled corticosteroid (ICS) in these patients.
    

Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention description(s): once daily inhalation with 400 µg budesonide (dry powder)during 6 weeks
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; FEF25-75; exhaled nitric oxide; inhaled corticosteroid; children