An interventional study of asthma treatment adjustment taking account on degree of bronchial hyperresponsiveness in Asthma in Children, sponsored by National Institute for Tuberculosis and Lung Diseases, Poland. Completed at 1 site in Poland. Open to participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by National Institute for Tuberculosis and Lung Diseases, Poland · Not applicable, Interventional, and Basic science
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:
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:
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 108 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →National Institute for Tuberculosis and Lung Diseases, Poland is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The asthma treatment adjustments guided by GINA guidelines
The asthma treatment adjustments additionally taking account to the results of the bronchial hyperresponsiveness test
Other: asthma treatment adjustment taking account on degree of bronchial hyperresponsiveness
Modification of inhaled corticosteroid dose based on the symptoms and the result of bronchial provocation (BHR group)
asthma exacerbations
number of asthma exacerbations
Time frame: 12 months
the percentage of participants with asthma exacerbations
the number of patients with at least 1 exacerbation divided by the number of patients in each group
Time frame: 12 months
time to the first asthma exacerbation
the median time to the first asthma exacerbation in each group
Time frame: 12 months
ICS dose
the final dose of ICS
Time frame: 12 months
days with symptoms
total number of days with asthma symptoms
Time frame: 12 months
days with asthma medication
total number of days with bronchodilator use
Time frame: 12 months
blood eosinophilia
number of blood eosinophils
Time frame: 12 months
exhaled nitric oxide
orally exhaled nitric oxide concentration
Time frame: 12 months
spirometry
FEV1, forced vital capacity (FVC) and FEF (MMEF) values
Time frame: 12 months
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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National Institute for Tuberculosis and Lung Diseases, Poland