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Trial record 50 of 318 for:    FLUTICASONE AND SALMETEROL

Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy

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ClinicalTrials.gov Identifier: NCT01347060
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : June 1, 2011
Last Update Posted : May 25, 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 xinafoate combination
Drug: inhaled corticosteroids
Enrollment 17448
Recruitment Details  
Pre-assignment Details Patients 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 patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
Arm/Group Title Fluticasone Propionate and Salmeterol Inhaled Corticosteroids
Hide Arm/Group Description Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
Period Title: Overall Study
Started 9868 7580
Completed 9868 7580
Not Completed 0 0
Arm/Group Title Fluticasone Propionate and Salmeterol Inhaled Corticosteroids Total
Hide Arm/Group Description Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known. Total of all reporting groups
Overall Number of Baseline Participants 9868 7580 17448
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9868 participants 7580 participants 17448 participants
65-69 years old 4153 3064 7217
70-74 years old 2694 2669 5363
75-79 years old 3021 1847 4868
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9868 participants 7580 participants 17448 participants
Female
6083
  61.6%
4800
  63.3%
10883
  62.4%
Male
3785
  38.4%
2780
  36.7%
6565
  37.6%
Number of participants with comorbid COPD at baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9868 participants 7580 participants 17448 participants
9227 7153 16380
[1]
Measure Description: International Classification of Disease-9 (ICD-9) codes 491, 492, 496, 490-492.8, 493.00-493.91, 494, 495.0-505, 506.4
1.Primary Outcome
Title Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
Hide Description Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database.
Time Frame Up to 7 years from July 1, 2001 to June 30, 2008
Hide Outcome Measure Data
Hide Analysis Population Description
Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.
Arm/Group Title Fluticasone Propionate and Salmeterol Inhaled Corticosteroids
Hide Arm/Group Description:
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
Overall Number of Participants Analyzed 9868 7580
Mean (Standard Deviation)
Unit of Measure: Asthma-related events
Inpatient visits 0.033  (0.21) 0.046  (0.25)
Emergency department visits 0.022  (0.18) 0.027  (0.20)
Inpatient/emergency department visits 0.05  (0.30) 0.07  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate and Salmeterol, Inhaled Corticosteroids
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0051
Comments The P-value relates to differences in combined inpatient/emergency department.
Method Regression, Cox
Comments Adjusted for baseline differences
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.68 to 0.93
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Asthma-related Costs in the Post-index Period
Hide Description Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill.
Time Frame Up to 7 years from July 1, 2001 to June 30, 2008
Hide Outcome Measure Data
Hide Analysis Population Description
Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.
Arm/Group Title Fluticasone Propionate and Salmeterol Inhaled Corticosteroids
Hide Arm/Group Description:
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
Overall Number of Participants Analyzed 9868 7580
Mean (Standard Deviation)
Unit of Measure: United States dollars
Medical Services Costs 381  (2859) 462  (2859)
Pharmacy Costs 1128  (1077) 939  (1125)
Total Asthma Costs 1509  (3832) 1401  (3151)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate and Salmeterol, Inhaled Corticosteroids
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments The P-value is on the adjusted difference in total asthma costs.
Method Regression, Linear
Comments Generalized Linear Model with a log-link and a gamma distribution adjusting for differences at baseline
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 883.23
Confidence Interval (2-Sided) 95%
731.66 to 1041.69
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant
Hide Description The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.
Time Frame Up to 7 years from July 1, 2001 to June 30, 2008
Hide Outcome Measure Data
Hide Analysis Population Description
Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.
Arm/Group Title Fluticasone Propionate and Salmeterol Inhaled Corticosteroids
Hide Arm/Group Description:
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
Overall Number of Participants Analyzed 9868 7580
Mean (Standard Deviation)
Unit of Measure: albuterol canisters
1.01  (2.26) 1.5  (2.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate and Salmeterol, Inhaled Corticosteroids
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description This was a retrospective observational study using a large health insurance claims database. Serious adverse events and non-serious adverse events were not collected.
 
Arm/Group Title Fluticasone Propionate and Salmeterol Inhaled Corticosteroids
Hide Arm/Group Description Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
All-Cause Mortality
Fluticasone Propionate and Salmeterol Inhaled Corticosteroids
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluticasone Propionate and Salmeterol Inhaled Corticosteroids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluticasone Propionate and Salmeterol Inhaled Corticosteroids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   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: NCT01347060     History of Changes
Other Study ID Numbers: 112605
First Submitted: June 10, 2010
First Posted: May 4, 2011
Results First Submitted: May 5, 2011
Results First Posted: June 1, 2011
Last Update Posted: May 25, 2017