Asthma in Children
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01286532
First received: January 28, 2011
Last updated: January 31, 2013
Last verified: January 2013
| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 28, 2011 |
| Last Updated Date | January 31, 2013 |
| Start Date ICMJE | April 2011 |
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01286532 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
|
| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Asthma in Children |
| Official Title ICMJE | 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 |
| Brief Summary | This is a six-month non-interventional prospective study of various controller therapies in children with asthma in outpatient clinical practice. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| 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 |
| Condition ICMJE | Asthma |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | 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 |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 283 |
| Completion Date | October 2012 |
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 5 Years to 11 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Russian Federation |
| Administrative Information | |
| NCT Number ICMJE | NCT01286532 |
| Other Study ID Numbers ICMJE | NIS-RRU-XXX-2010/1 |
| Has Data Monitoring Committee | No |
| Responsible Party | AstraZeneca |
| Study Sponsor ICMJE | AstraZeneca |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | AstraZeneca |
| Verification Date | January 2013 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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