N/A
N=101,437
Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01346852 ↗Enrolled (actual)
101,437
Serious AEs
—
Results posted
Jun 2011
Primary outcome: Primary: Mean Ratio of Controller Medication to Total Asthma Medication — 0.57; 0.66; 0.66; 0.71 ratio
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Asthma treatment with an asthma-related medication and at least one asthma controller medication (Drug)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ratio of Controller Medication to Total Asthma Medication |
0.57; 0.66; 0.66; 0.71; 0.63; 0.70 | — |
| SECONDARY Mean Number of Short-acting Beta-agonist (SABA) Canisters Used |
1.03; 1.04; 1.24; 1.28; 1.72; 1.82 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01346852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.