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OpenTrials
Completed

NCT Number: NCT01286532

Asthma in Children

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

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Key information

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research site, Chelyabinsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. To determine mean number of severe bronchial asthma exacerbations within 6 months

    Time frame: 3 visits for 6 month

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 31, 2011
Registry last updated
Feb 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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