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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
Sponsor:
Collaborators:
University of Rzeszow
The Regional Public Hospital in Lesko, Poland
Information provided by (Responsible Party):
National Institute for Tuberculosis and Lung Diseases, Poland

Brief Summary:

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

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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
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
stable asthma

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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in sputum eosinophilia [ Time Frame: at 1, 3, 4, 6 and 7 month ]
    eosinophil percentage in induced sputum compared to baseline


Other Outcome Measures:
  1. 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

  2. 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

  3. Change in exhaled NO [ Time Frame: months 1 - 8 ]
    Measured every month and compared to baseline

  4. Change in exhaled breath temperature (EBT) [ Time Frame: months 1 - 8 ]
    Measured every month and compared to baseline

  5. Change in FEV1 [ Time Frame: months 1 - 8 ]
    Measured every month and compared to baseline

  6. Change in FVC [ Time Frame: months 1 - 8 ]
    Measured every month and compared to baseline

  7. Change in FEF25-75 [ Time Frame: months 1 - 8 ]
    Measured every month and compared to baseline



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mild or moderate asthma with a stable course of at least 3 months:

    • symptoms less than 4x per week,
    • use of SABA below 3x a week,
    • night awakening below 1x per week,
    • FEV1> 80% of predicted
    • no dose change in ICS or use of systemic steroids from 3 months
  • good adherence to treatment

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

Information from the National Library of Medicine

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


Contacts
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Contact: Henryk Mazurek, MD, PhD +48 602440286 hmazurek@igrabka.edu.pl

Locations
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Poland
The Regional Public Hospital in Lesko, Poland Recruiting
Lesko, Poland, 38-600
Contact: Janusz Ciółkowski, MD    +48134698071    ciolkowski.janusz@gmail.com   
Sponsors and Collaborators
National Institute for Tuberculosis and Lung Diseases, Poland
University of Rzeszow
The Regional Public Hospital in Lesko, Poland

Publications of Results:
www.ginasthma.org

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Responsible Party: National Institute for Tuberculosis and Lung Diseases, Poland
ClinicalTrials.gov Identifier: NCT03788057     History of Changes
Other Study ID Numbers: NITLD
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases