Asthma in Children

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286532
• Other study ID #: NIS-RRU-XXX-2010/1
• Status: Completed
• Phase: N/A
• First received: January 28, 2011
• Last updated: January 31, 2013
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 11 Years

Eligibility

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 ß2 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, a1-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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Russian Federation	Research site	Cheliabinsk
Russian Federation	Research site	Moscow
Russian Federation	Research site	N.Novgorod
Russian Federation	Research site	Novosibirsk
Russian Federation	Research site	Rostov-on-Don
Russian Federation	Research site	Samara
Russian Federation	Research site	St. Petersburg
Russian Federation	Research site	Tula
Russian Federation	Research site	Tver
Russian Federation	Research site	Ufa
Russian Federation	Research site	Volgograd

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine mean number of severe bronchial asthma exacerbations within 6 months		3 visits for 6 month	No
Secondary	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	No
Secondary	To determine mean requirement in short-acting ß2-agonists and/or rapidly released methylxanthines per week during the period of observation		3 visits for 6 month	No
Secondary	To determine the independent factors associated with failure of treatment of asthma (demographic and baseline patient data, site)		3 visits for 6 month	No