Last updated: 11/07/2018 04:54:50
Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
Trial description: The purpose of this study is to assess the predictive ability of three asthma risk markers: the ratio of controller medication to total asthma medication, an albuterol only marker, and an oral corticosteroid use marker, as well as to compare the precision of these tools between adult and pediatric patient populations. This retrospective longitudinal analysis will use 2 different databases: a large managed care database and a large fee for service Medicaid database.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean ratio of controller medication to total asthma medication
Timeframe: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
Secondary outcomes:
Mean number of short-acting beta-agonist (SABA) canisters used
Timeframe: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
Interventions:
Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication
Enrollment:
101437
Observational study model:
Cohort
Primary completion date:
2010-01-05
Time perspective:
Retrospective
Clinical publications:
Stanford, Shah, D'Souza, Schatz. Predicting Asthma Outcomes in Patients within Commerically- insured and Medicaid Populations. Am J Manag Care. 2013;19(1):60-67.
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
GSK
Study date(s)
July 2009 to May 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
4+ years
Accepts healthy volunteers
No
- Subjects with asthma as determined by ICD-9 codes and asthma drug use
- at least 4 years of age
- Subjects with COPD or treatment for COPD
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with asthma as determined by ICD-9 codes and asthma drug use
- at least 4 years of age
- use of at least 1 controller or at least 5 albuterol prescriptions in 12 months
Exclusion criteria:
- Subjects with COPD or treatment for COPD
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2010-01-05
Actual study completion date
2010-01-05
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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