Adjustment of Asthma Treatment in Children Based on an Indirect Hyperresponsiveness Test
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The aim of the study is to assess the usefulness of the indirect bronchial
      hyperresponsiveness test (with hypertonic NaCl) in determining the optimal dose of inhaled
      steroids to maintain asthma control.

      The study was designed as a prospective, real-life, randomized, interventional study. This
      single-site study is performed at the Allergology Clinic in Lesko.

      The study included participants aged 7-15 years who met the eligibility criteria. Eligible
      participants were selected from a pool of 231 patients with mild asthma, under the care of
      the Allergology Clinic of the Regional Public Hospital in Lesko (Poland). All participants
      were diagnosed with chronic mild asthma for at least two years.

      Subjects initially enrolled in the study had good asthma control maintained for at least 3
      months on low / medium-dose ICS monotherapy, with no exacerbations requiring systemic
      corticosteroids in the previous 3 months, no respiratory tract infection in last month, and
      an FEV1 above 80% expected.

      Finally, 108 children were enrolled in the study. They were aged 7-15 years, with active mild
      asthma, confirmed by the presence of bronchial hyperreactivity and symptoms of asthma,
      emerging after discontinuation of anti-inflammatory treatment.

      Participation in the study lasted one year.

      The study includes:

      4-week run-in period (withdrawal phase) after discontinuation of anti-inflammatory treatment
      (ICS) with clinical symptoms and medication use recording, completed by the patient and
      parents.

      At the end of this period, spirometry was performed, bronchial hyperreactivity was assessed
      with the hyperosmolar salt provocation, and the parameters of inflammation were measured:
      orally exhaled nitric oxide concentration (NO) and peripheral blood eosinophilia. The
      anti-inflammatory treatment was then resumed (with ICS in the previous doses).

      Only patients with active asthma and increased bronchial responsiveness (DRS>0.55) were
      qualified for the main study. Stratified randomization was performed for age, clinical
      symptoms, and the degree of bronchial hyperresponsiveness. On this basis, the division into 2
      research groups was made:

        -  a symptom-only monitored treatment group

        -  a group in which therapy changes were based on the symptoms and degree of bronchial
           hyperresponsiveness (BHR group).

      Patients/parents were provided by an established algorithm for managing asthma
      symptoms/exacerbations. In the case of loss of asthma control, a beta-agonist was
      administered (temporarily) and the dose of ICS quadrupled. Patients had the possibility of
      additional visits - if necessary. Especially, severe exacerbations were verified by the
      attending physician, and on this basis, oral steroids would be considered.

      Throughout the study, the participants kept daily observation charts (clinical symptoms and
      drug use) and peak expiratory flow rate (PEFR) measurements.

      The telephone report was made monthly with the number of days with asthma symptoms and
      medications used, and this was recorded in the documentation of the study.

      The clinical evaluation was performed every 3 months with symptom evaluation, spirometry,
      exhaled NO, peripheral blood eosinophilia, and BHR measurements (half of the patients).

      The treatment adjustments were guided by the patient's and parent's reporting of symptoms,
      and additionally by the results of periodic clinical assessment (including the assessment of
      bronchial hyperresponsiveness in the BHR group). This means that the level of treatment
      intensity (ICS dose) was based on symptom monitoring only in the observation group, and
      additionally took into account the level of bronchial responsiveness in the BHR monitoring
      group.

      The study was completed after one year of follow-up (4 visits every 3 months). The primary
      endpoint of the study: the number of asthma exacerbations in both study arms.

      Secondary endpoints:

        -  days with symptoms

        -  asthma medication days

        -  final dose of ICS

        -  spirometry (FEV1, MMEF)

        -  bronchial hyperreactivity (BHR group only)

        -  nitric oxide in the exhaled air

        -  peripheral blood eosinophilia.
    


Intervention name(s): asthma treatment adjustment taking account on degree of bronchial hyperresponsiveness
Intervention type(s): Other
Intervention description(s): Modification of inhaled corticosteroid dose based on the symptoms and the result of bronchial provocation (BHR group)
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: asthma; bronchoprovocation; inhaled corticosteroids