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Asthma in Children

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ClinicalTrials.gov Identifier: NCT01286532
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):

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

Condition or disease

Study Type : Observational
Actual Enrollment : 283 participants
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
Study Start Date : April 2011
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

Primary Outcome Measures :
  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) [ Time Frame: 3 visits for 6 month ]

Secondary Outcome Measures :
  1. To determine mean number of severe bronchial asthma exacerbations within 6 months [ Time Frame: 3 visits for 6 month ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286532

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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01286532     History of Changes
Other Study ID Numbers: NIS-RRU-XXX-2010/1
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013

Keywords provided by AstraZeneca:
Asthma, Asthma in Children

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