Inflammatory Indices in Predicting the Failure of Inhaled Corticosteroids Reduction in Young Participants With Asthma
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|ClinicalTrials.gov Identifier: NCT03788057|
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
A prospective, observational, interventional, single-blind study (blinded for a clinician in the field of inflammatory parameters).
The aim of the study is evaluation of the usefulness of induced sputum eosinophilia and other inflammatory indices [exhaled nitric oxide (NO), exhaled breath temperature, bronchial hyperresponsiveness] in predicting the failure of treatment reduction with inhaled corticosteroids (ICS) in stable asthma in children and adolescents.
In participants with a stable course of the asthma (confirmed in the run -in period), every 3 months the dose of ICS is halved (according to GINA guidelines) until the control is lost or the lowest daily ICS dose is reached (200 mcg, calculated as budesonide equivalent). Throughout the treatment reduction period, the participants run an observation card (clinical symptoms) and peak expiratory flow rate (PEFR) measurements. Clinical evaluation is performed every month, with spirometry, exhaled NO and exhaled breath temperature measurements. Before the reduction and then one month after the change of treatment, the hyperresponsiveness measurement is carried out with the sputum induction (combined method using hypertonic saline), and 2 months after the change of treatment with the exercise challenge test.
In the case of loss of asthma control, beta-mimetic will be administered (temporarily) and return to dose of ICS before reduction or further increase of treatment is planned. In severe asthma exacerbations, oral steroids will be considered.
The study is observational: treatment is modified according to GINA guidelines based on clinical data as part of routine medical care. Only difference compared do standard care is supplementary inflammation evaluation (exhaled NO, sputum eosinophilia, bronchial hyperreactivity).
|Condition or disease||Intervention/treatment||Phase|
|Asthma Chronic||Other: ICS dose reduction||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A prospective, observational, interventional, single blind study. Clinician takes decision about possible reduction of ICS dose basing on clinical data only - is not aware of the results of the inflammatory parameters measurement.|
|Masking:||None (Open Label)|
|Masking Description:||Clinician takes decision about possible change in treatment basing on clinical data only - is not aware of the results of the inflammatory parameters measurements|
|Official Title:||Evaluation of the Usefulness of Induced Sputum Eosinophilia, eNO and Bronchial Hyperresponsiveness in Predicting the Failure of Inhaled Corticosteroids Dose Reduction in Children and Adolescents With Stable Asthma|
|Actual Study Start Date :||February 1, 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||October 2019|
In patients with previously stable course of the asthma, every 3 months the symptoms are evaluated and the dose of ICS is customized - in accordance with the GINA guidelines. This decision is based solely on clinical data (control of symptoms) and is the same as in patients not participating in the study.
In patients participating in the study, inflammatory parameters are also measured (sputum eosinophilia, eNO, EBT, bronchial reactivity), but results are not known to clinician taking decision about possible ICS dose reduction.
Other: ICS dose reduction
If control of symptoms is maintained (evaluation based on clinical symptoms solely), every 3 months the dose of ICS is halved according to GINA guidelines, until the control is lost or the lowest daily dose is reached (200 mcg, calculated as budesonide equivalent).
In the case of loss of asthma control, beta-mimetic will be administered (temporarily) and return to the chronic administration of the previous, twice higher dose of ICS is restored (or further increase of treatment). In severe exacerbations, inclusion of oral steroids will be considered.
- The percentage of patients with loss of asthma control [ Time Frame: at 9 months ]
Criteria for loss of control (any of the following):
- use of bronchodilators > 5 times a week
- the need for treatment with oral corticosteroids
- PEFR decrease >20% for 2 consecutive days, compared to the average run-in period
- Change in sputum eosinophilia [ Time Frame: at 1, 3, 4, 6 and 7 month ]eosinophil percentage in induced sputum compared to baseline
- Change in airway hyperresponsiveness to hypertonic saline [ Time Frame: at 1, 3, 4, 6 and 7 month ]Airway hyperresponsiveness to hypertonic saline measured using combined method (together with sputum induction) and compared to baseline
- Change in airway hyperresponsiveness (exercise) [ Time Frame: at 2, 5 and 8 month ]Airway hyperresponsiveness measured using an exercise challenge test and compared to baseline
- Change in exhaled NO [ Time Frame: months 1 - 8 ]Measured every month and compared to baseline
- Change in exhaled breath temperature (EBT) [ Time Frame: months 1 - 8 ]Measured every month and compared to baseline
- Change in FEV1 [ Time Frame: months 1 - 8 ]Measured every month and compared to baseline
- Change in FVC [ Time Frame: months 1 - 8 ]Measured every month and compared to baseline
- Change in FEF25-75 [ Time Frame: months 1 - 8 ]Measured every month and compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788057
|Contact: Henryk Mazurek, MD, PhD||+48 firstname.lastname@example.org|
|The Regional Public Hospital in Lesko, Poland||Recruiting|
|Lesko, Poland, 38-600|
|Contact: Janusz Ciółkowski, MD +48134698071 email@example.com|