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Trial record 99 of 151 for:    Ipratropium OR atrovent

Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population

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ClinicalTrials.gov Identifier: NCT01337336
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : May 20, 2011
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: fluticasone propionate/salmeterol xinafoate
Drug: Anticholinergics
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FSC Cohort AC Cohort
Hide Arm/Group Description Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
Period Title: Overall Study
Started 1078 2923
Completed 1078 2923
Not Completed 0 0
Arm/Group Title FSC Cohort AC Cohort Total
Hide Arm/Group Description Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available. Total of all reporting groups
Overall Number of Baseline Participants 1078 2923 4001
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1078 participants 2923 participants 4001 participants
57.8  (9.8) 60.3  (10.3) 59.6  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1078 participants 2923 participants 4001 participants
Female
742
  68.8%
1910
  65.3%
2652
  66.3%
Male
336
  31.2%
1013
  34.7%
1349
  33.7%
1.Primary Outcome
Title Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation
Hide Description The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
Time Frame Maximum of 1 year after index date (January 1, 2004 to June 30, 2009)
Hide Outcome Measure Data
Hide Analysis Population Description
Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).
Arm/Group Title FSC Cohort AC Cohort
Hide Arm/Group Description:
Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
Overall Number of Participants Analyzed 1078 2923
Measure Type: Number
Unit of Measure: participants
200 674
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FSC Cohort, AC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.30
Confidence Interval 95%
1.08 to 1.56
Estimation Comments Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.
2.Secondary Outcome
Title Number of Participants With the Indicated COPD-related Exacerbations
Hide Description The number of participants with a COPD-related exacerbation was identified during the follow-up period. Four types of COPD-related exacerbations were defined: COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, or combined occurrence of COPD-related hospitalization/ER visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
Time Frame Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)
Hide Outcome Measure Data
Hide Analysis Population Description
Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintanance medication for COPD (index date).
Arm/Group Title FSC Cohort AC Cohort
Hide Arm/Group Description:
Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
Overall Number of Participants Analyzed 1078 2923
Measure Type: Number
Unit of Measure: participants
COPD-related hospitalization 35 168
COPD-related ER visit 37 171
COPD-related physician + Rx visit 156 448
COPD-related hospitalization/ER visit 63 307
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FSC Cohort, AC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments COPD-related hospitalization
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.56
Confidence Interval 95%
1.02 to 2.38
Estimation Comments Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FSC Cohort, AC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments COPD-related ER visit
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.65
Confidence Interval 95%
1.14 to 2.39
Estimation Comments Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FSC Cohort, AC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.503
Comments [Not Specified]
Method Chi-squared
Comments COPD-related physician + Rx visit
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.14
Confidence Interval 95%
0.93 to 1.40
Estimation Comments Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FSC Cohort, AC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments COPD-related hospitalization/ER visit
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.71
Confidence Interval 95%
1.26 to 2.31
Estimation Comments Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.
3.Secondary Outcome
Title Mean Annual COPD-related Costs Per Participant
Hide Description Cost categories included medical, pharmacy, and total (calculated as the sum of medical and pharmacy). COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
Time Frame Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)
Hide Outcome Measure Data
Hide Analysis Population Description
Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).
Arm/Group Title FSC Cohort AC Cohort
Hide Arm/Group Description:
Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
Overall Number of Participants Analyzed 1078 2923
Mean (Standard Deviation)
Unit of Measure: United States (US) dollars
COPD-related total costs 1604  (3187) 1687  (4299)
COPD-related pharmacy costs 934  (814) 684  (724)
COPD-related medical costs 670  (2923) 1003  (4095)
4.Secondary Outcome
Title Number of the Indicated COPD-related Exacerbations
Hide Description The number of COPD-related exacerbations was identified during the follow-up period. Five types of COPD-related exacerbations were defined: -COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, combined occurrence of COPD-related hospitalization/ER visit, or combined occurrence of any COPD-related exacerbation. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
Time Frame Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)
Hide Outcome Measure Data
Hide Analysis Population Description
Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).
Arm/Group Title FSC Cohort AC Cohort
Hide Arm/Group Description:
Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
Overall Number of Participants Analyzed 1078 2923
Mean (Standard Deviation)
Unit of Measure: number of exacerbations
COPD-related hospitalization 0.04  (0.2) 0.07  (0.3)
COPD-related ER visit 0.06  (0.4) 0.07  (0.4)
COPD-related physician (phy)+Rx visit 0.19  (0.6) 0.20  (0.6)
COPD-related hospitalization/ER visit 0.09  (0.5) 0.14  (0.5)
COPD-related hospitalization/ER visit/phy+Rx visit 0.29  (0.8) 0.34  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FSC Cohort, AC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments COPD-related hospitalization
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Rate Ratio
Estimated Value 1.46
Confidence Interval 95%
1.01 to 2.09
Estimation Comments Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FSC Cohort, AC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.208
Comments COPD-related ER visit
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Rate Ratio
Estimated Value 1.27
Confidence Interval 95%
0.89 to 1.82
Estimation Comments Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FSC Cohort, AC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.671
Comments COPD-related physician + Rx visit
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Rate Ratio
Estimated Value 1.09
Confidence Interval 95%
0.90 to 1.32
Estimation Comments Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FSC Cohort, AC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments COPD-related hospitalization/ER visit
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Rate Ratio
Estimated Value 1.31
Confidence Interval 95%
1.05 to 1.72
Estimation Comments Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection FSC Cohort, AC Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments COPD-related hospitalization/ER visit/physician + Rx visit
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Rate Ratio
Estimated Value 1.16
Confidence Interval 95%
0.98 to 1.37
Estimation Comments Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.
Time Frame [Not Specified]
Adverse Event Reporting Description This study was a retrospective observational study; thus, no serious adverse events or adverse events were collected.
 
Arm/Group Title FSC Cohort AC Cohort
Hide Arm/Group Description Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day Anticholinergics (AC) include iotropium, and Ipratropium, Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
All-Cause Mortality
FSC Cohort AC Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FSC Cohort AC Cohort
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%
FSC Cohort AC Cohort
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: NCT01337336     History of Changes
Other Study ID Numbers: 113902
First Submitted: April 15, 2011
First Posted: April 18, 2011
Results First Submitted: April 21, 2011
Results First Posted: May 20, 2011
Last Update Posted: May 30, 2017