Asthma in Children

Completed

• Conditions: Asthma

• Registration Number: NCT01286532
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-28
• Study First Submitted QC: 2011-01-28
• Study First Posted: 2011-01-31
• Study Start: 2011-04
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research site; 🇷🇺 Volgograd, Russian Federation