Asthma in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

283 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-10-31

Brief Summary

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This is a six-month non-interventional prospective study of various controller therapies in children with asthma in outpatient clinical practice.

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Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Children (male or female) aged 5 to 11 years inclusive on step 3 asthma combination therapy with ICS(inhalation glucocorticosteroids) and LABA ( long-acting b2-agonist) who have completed at least one valid CACT assessment after the study entry

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Child (male or female) aged 5 to 11 years inclusive
* Provision of Subject Informed Consent Form for anonymous data collection and their subsequent use (must be signed by any of the parents)
* The child must be included in an out-patient observation program at a medical institution for established bronchial asthma diagnosis for at least 1 year prior to enrolment and diagnosed with moderate to severe bronchial asthma at the time of enrolment
* The child must have at least one documented bronchial asthma exacerbation in previous 1 year (including hospital admissions for bronchial asthma exacerbations, any cases of daytime hospital treatment without overnight stays and any cases of oral administration of glucocorticoids on an out-patient basis for \> 3 consecutive days)
* Out-patient receiving step 3 controller treatments with fixed dose combinations of ICSs and LABA or treatment with separate administration of glucocorticoids and LABA in stable doses with adequate control of bronchial asthma symptoms
* The patient administered with short-acting β2 agonists (inhalational) or rapidly released methylxanthines (oral) in the doses approved for the respective age as a rescue on-demand therapies during the preceding month

Exclusion Criteria

* Cystic fibrosis, α1-antitrypsin deficiency or congenital abnormalities of lung development
* Severe comorbidities affecting the patient's overall performance
* In the physician's opinion, the patient is not able to comply with the protocol requirements
* Expected specific hyposensibilization within next 6 months
* Expected treatment at health resort facilities within next 6 months
* Other reasons that in the physician's opinion will prevent reliable assessments of the study treatment efficacy

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No