NCT01332344

Brief Summary

The objective of this study is to compare healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg ("FSC 100/50") or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care database.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,180

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

March 4, 2010

Last Update Submit

June 1, 2017

Conditions

Keywords

fluticasone propionate/salmeterol combinationAsthmainhaled corticosteroidsoutcomes

Outcome Measures

Primary Outcomes (1)

  • To assess the difference in asthma related exacerbations

    Asthma related exaceberation is defined as any asthma related emergency department visit, or inpatient visit or oral corticosteroid dispensing.

    90 days post index

Study Arms (1)

Asthma patients treated with inhaled corticosteroids

Asthma subjects newly prescribed inhaled corticosteriods

Drug: Fluticasone propionate/salmeterol combinationDrug: Inhaled corticosteroids

Interventions

Asthma subjects newly prescribed fluticasone propionate/salmeterol combination

Asthma patients treated with inhaled corticosteroids

asthma subjects newly prescribed inhaled corticosteroids in clinical practice

Asthma patients treated with inhaled corticosteroids

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study intends to identify subjects with asthma treated with inhaled corticosteroids

You may qualify if:

  • Subjects with asthma as determined by ICD-9 codes and asthma drug use
  • at least 12 years of age
  • treated with inhaled corticosteroids

You may not qualify if:

  • Subjects with COPD or treatment for COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol XinafoateAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesFluticasoneAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2010

First Posted

April 11, 2011

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 2, 2017

Record last verified: 2017-06