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
1 other identifier
observational
283
1 country
11
Brief Summary
This is a six-month non-interventional prospective study of various controller therapies in children with asthma in outpatient clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2011
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2011
CompletedFirst Posted
Study publicly available on registry
January 31, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFebruary 1, 2013
January 1, 2013
1.5 years
January 28, 2011
January 31, 2013
Conditions
Keywords
Outcome Measures
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)
3 visits for 6 month
Secondary Outcomes (4)
To determine mean number of severe bronchial asthma exacerbations within 6 months
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
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
3 visits for 6 month
To determine the independent factors associated with failure of treatment of asthma (demographic and baseline patient data, site)
3 visits for 6 month
Study Arms (1)
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
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (11)
Research site
Chelyabinsk, Russia
Research site
Moscow, Russia
Research site
N.Novgorod, Russia
Research site
Novosibirsk, Russia
Research site
Rostov-on-Don, Russia
Research site
Saint Petersburg, Russia
Research site
Samara, Russia
Research site
Tula, Russia
Research site
Tver', Russia
Research site
Ufa, Russia
Research site
Volgograd, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2011
First Posted
January 31, 2011
Study Start
April 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
February 1, 2013
Record last verified: 2013-01