Trial Outcomes & Findings for Inflammatory Indices in Predicting the Failure of Inhaled Corticosteroids Reduction in Young Participants With Asthma (NCT NCT03788057)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

at 9 months

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	58
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inflammatory Indices in Predicting the Failure of Inhaled Corticosteroids Reduction in Young Participants With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stable Asthma n=52 Participants In patients with a previously stable course of 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 decisions about possible 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). 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
Age, Categorical <=18 years	52 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Stable Asthma n=52 Participants 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. 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	17 Participants

SECONDARY outcome

Timeframe: at 1, 3, 4, 6 and 7 month

eosinophil percentage in induced sputum compared to baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at 2, 5 and 8 month

Airway hyperresponsiveness measured using an exercise challenge test and compared to baseline