Asthma in Children

A Six-month Non-interventional Prospective Study of Various Controller Therapies for Moderate Persistent and Severe Persistent Asthma in Children in Real Life Outpatient Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01286532

Enrollment

283

Registered

2011-01-31

Start date

2011-04-30

Completion date

2012-10-31

Last updated

2013-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Asthma in Children

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 11 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To compare percentage (%) of responding children by the end of 6-month observation. Responders are defined as children with adequate control of symptoms at the end of 6 months observation (Childhood Asthma Control Test (CACT) score > 19)	3 visits for 6 month

Secondary

Measure	Time frame
To determine mean number of severe bronchial asthma exacerbations within 6 months	3 visits for 6 month
To determine mean duration of bronchial asthma exacerbations including hospital admissions, daytime hospital treatment and any cases of oral administration of glucocorticoids > 3 consecutive days during the observation period	3 visits for 6 month
To determine mean requirement in short-acting β2-agonists and/or rapidly released methylxanthines per week during the period of observation	3 visits for 6 month
To determine the independent factors associated with failure of treatment of asthma (demographic and baseline patient data, site)	3 visits for 6 month

Countries

Russia

Outcome results