Asthma in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01286532
First received: January 28, 2011
Last updated: January 31, 2013
Last verified: January 2013

January 28, 2011
January 31, 2013
April 2011
October 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01286532 on ClinicalTrials.gov Archive Site
  • To determine mean number of severe bronchial asthma exacerbations within 6 months [ Time Frame: 3 visits for 6 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine mean number of severe bronchial asthma exacerbations within 6 months [ Time Frame: 3 visits for 6 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Asthma in Children
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

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Children (male or female) aged 5 to 11 years inclusive on step 3 asthma combination therapy with ICS and LABA who have completed at least one valid CACT assessment after the study entry

Asthma
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
283
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
5 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01286532
NIS-RRU-XXX-2010/1
No
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP