CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9,906 enrolled
Drug / intervention
Fluticasone propionate +2 moredrug
Likely dose
Fluticasone propionate 44 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01328964
NCT01328964N/ACompleted

Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population

GlaxoSmithKline·observational·Posted Apr 5, 2011·Updated Jul 6, 2017

In Brief

An observational study evaluating Fluticasone propionate, Budesonide, and 1 other intervention for Asthma. Completed, enrolled 9,906 participants.

Detailed Summary

The objective of this study is to compare asthma-related exacerbations (emergency department (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that received either fluticasone propionate 44 mcg (FP44) or budesonide (BUD) or montelukast (MON). This retrospective observational cohort analysis utilizes a large managed care database with linked pharmacy and medical claims. Patients with ≥ 1 pharmacy claim FP44 or BUD or MON between January 1, 2000 through June 30, 2008 (4-11 years old at time of index) with ≥ 1 diagnosis for asthma (ICD-9 493.xx) in the pre-index period and continuously eligible to receive healthcare services for 1-year pre-index and at least 30 days post-index. Dose of each inhaled corticosteroid was not known in the database. Follow-up was defined for each patient as the period beginning with the index date and ending with the last date of continuous claims history, switch to another asthma controller medication, or claim for an asthma related event (ED/IP visit or OCS use) post-index, whichever occurred first.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 5, 2011
Enrollment StartJun 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.2 years ago

Interventions

Fluticasone propionatedrug

fluticasone propionate 44 mcg

Budesonidedrug

budesonide

Montelukastdrug

montelukast