Asthma in Children


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

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2012

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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)
    • Time Frame: 3 visits for 6 month

Secondary Measures

  • To determine mean number of severe bronchial asthma exacerbations within 6 months
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 3 visits for 6 month
  • To determine the independent factors associated with failure of treatment of asthma (demographic and baseline patient data, site)
    • Time Frame: 3 visits for 6 month

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor

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