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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 22, 2013