Asthma in Children

AstraZeneca

Status: Completed

Conditions: Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT01286532

NIS-RRU-XXX-2010/1

Details and patient eligibility

About

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

Enrollment: 283 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No 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

Trial design

283 participants in 1 patient group

1

Description:

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