Adjustment of Asthma Treatment in Children Based on an Indirect Hyperresponsiveness Test

August 11, 2020 updated by: Henryk Mazurek, National Institute for Tuberculosis and Lung Diseases, Poland

Adjustment of Asthma Treatment in Children Based on an Indirect Hyperresponsiveness Test - a Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lesko, Poland, 38-600
        • The Regional Public Hospital in Lesko, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mild asthma with a stable course of at least 3 months
  • good adherence to treatment with low dose ICS

Exclusion Criteria:

  • infection or exacerbation of asthma requiring the use of systemic steroids (or changes in the dose of inhaled steroids) in the last 3 months before the study
  • other chronic lung diseases or general diseases affecting the respiratory system
  • tobacco smoking
  • FEV1 below 80% of the predicted value

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: symptoms group
The asthma treatment adjustments guided by GINA guidelines
Experimental: BHR group
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
asthma exacerbations
Time Frame: 12 months
number of asthma exacerbations
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage of participants with asthma exacerbations
Time Frame: 12 months
the number of patients with at least 1 exacerbation divided by the number of patients in each group
12 months
time to the first asthma exacerbation
Time Frame: 12 months
the median time to the first asthma exacerbation in each group
12 months
ICS dose
Time Frame: 12 months
the final dose of ICS
12 months
days with symptoms
Time Frame: 12 months
total number of days with asthma symptoms
12 months
days with asthma medication
Time Frame: 12 months
total number of days with bronchodilator use
12 months
blood eosinophilia
Time Frame: 12 months
number of blood eosinophils
12 months
exhaled nitric oxide
Time Frame: 12 months
orally exhaled nitric oxide concentration
12 months
spirometry
Time Frame: 12 months
FEV1, forced vital capacity (FVC) and FEF (MMEF) values
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

Collaborators

University of Rzeszow
The Regional Public Hospital in Lesko, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2018

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA_BHR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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