Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 318 for:    FLUTICASONE AND SALMETEROL

Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01332357
Recruitment Status : Completed
First Posted : April 11, 2011
Results First Posted : October 13, 2011
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Asthma
Interventions Drug: Fluticasone propionate/salmeterol combination ED MD
Drug: Fluticasone propionate/salmeterol combination OP MD
Enrollment 6139
Recruitment Details  
Pre-assignment Details Participants were not recruited for, nor enrolled in, this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
Arm/Group Title Total Population
Hide Arm/Group Description Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
Period Title: Overall Study
Started 6139
Completed 6139
Not Completed 0
Arm/Group Title Total Population
Hide Arm/Group Description Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
Overall Number of Baseline Participants 6139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6139 participants
22.36  (17.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6139 participants
Female
3392
  55.3%
Male
2747
  44.7%
Type of Index Event   [1] 
Measure Type: Number
Unit of measure:  Visits
Number Analyzed 6139 participants
Inpatient hospitalizations 1331
Emergency Department Visit 4808
[1]
Measure Description: The number of inpatient visits and emergency department visits that defined the index event are reported.
Charlson Comorbidity Index Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 6139 participants
1.14  (0.57)
[1]
Measure Description: The Charlson Comorbidity Index estimates 10-year mortality risk. Scores range from 0 - 37, with a lower score indicating a higher chance of survival.
1.Primary Outcome
Title Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event
Hide Description A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.
Time Frame Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.
Hide Outcome Measure Data
Hide Analysis Population Description
Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
Arm/Group Title Total Population
Hide Arm/Group Description:
Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
Overall Number of Participants Analyzed 6139
Measure Type: Number
Unit of Measure: participants
915
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Population
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The unadjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.96
Confidence Interval (2-Sided) 95%
1.56 to 2.46
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Population
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The adjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge
Method Regression, Cox
Comments Covariates included demographics, IP or ED index event, primary asthma diagnosis, Charlson score, and pre-index medication
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.79
Confidence Interval (2-Sided) 95%
1.42 to 2.25
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Total Population
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge by time interaction
Method Regression, Cox
Comments Evaluates the impact of each day treatment with a controller was delayed
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.008
Confidence Interval (2-Sided) 95%
1.005 to 1.011
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description This is a retrospective study of pre-existing medical records and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible.
 
Arm/Group Title Total Population
Hide Arm/Group Description Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
All-Cause Mortality
Total Population
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total Population
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Total Population
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332357     History of Changes
Other Study ID Numbers: 112606
First Submitted: April 7, 2011
First Posted: April 11, 2011
Results First Submitted: September 8, 2011
Results First Posted: October 13, 2011
Last Update Posted: July 6, 2017