Asthma in Children

Overview

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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.