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
  Purpose

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


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 283
Study Start Date: April 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286532

Locations
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, Russian Federation
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01286532     History of Changes
Other Study ID Numbers: NIS-RRU-XXX-2010/1
Study First Received: January 28, 2011
Last Updated: January 31, 2013
Health Authority: Russia: Ethics Committee

Keywords provided by AstraZeneca:
Asthma, Asthma in Children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014