Clinical trial NCT01286532: Asthma in Children
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma, Asthma in Children
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-01-31
Enrollment: 283
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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


Eligibility criteria: 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

Primary outcomes:
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)
timeFrame: 3 visits for 6 month
Secondary outcomes:
measure: To determine mean number of severe bronchial asthma exacerbations within 6 months
timeFrame: 3 visits for 6 month
measure: 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
timeFrame: 3 visits for 6 month
measure: To determine mean requirement in short-acting β2-agonists and/or rapidly released methylxanthines per week during the period of observation
timeFrame: 3 visits for 6 month
measure: To determine the independent factors associated with failure of treatment of asthma (demographic and baseline patient data, site)
timeFrame: 3 visits for 6 month
Other outcomes:
Locations:
city: Cheliabinsk
country: Russian Federation
facility: Research site
city: Moscow
country: Russian Federation
facility: Research site
city: N.Novgorod
country: Russian Federation
facility: Research site
city: Novosibirsk
country: Russian Federation
facility: Research site
city: Rostov-on-Don
country: Russian Federation
facility: Research site
city: Samara
country: Russian Federation
facility: Research site
city: St. Petersburg
country: Russian Federation
facility: Research site
city: Tula
country: Russian Federation
facility: Research site
city: Tver
country: Russian Federation
facility: Research site
city: Ufa
country: Russian Federation
facility: Research site
city: Volgograd
country: Russian Federation
facility: Research site
Study officials:
References: