Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332461
First received: March 18, 2011
Last updated: August 4, 2011
Last verified: June 2011
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Purpose
This was a retrospective cross-sectional database study using administrative data (study period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged >40 years) having at least one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index event) during the study period was the target population. All subjects were required to have one year of pre-index period baseline data. COPD events of interest were ER, Hospital and physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days. Other censoring events were treatment switch; loss of enrollment; >60-day gap between medication fills; or end of study period.
This study is a non descriptive hypothesis testing study. Key study hypotheses are listed below.
Specifically the study hypotheses for the primary outcome being tested were:
Ho: There is no difference in risk of COPD-related hospitalization between FSC and OMT Ha: There is a difference in risk of COPD-related hospitalization between FSC and OMT
Hypothesis for the key secondary outcome of COPD-related costs that was tested was:
Ho: There is no difference in COPD-related costs between FSC and OMT Ha: There is a difference in COPD-related costs between FSC and OMT
| Condition | Intervention |
|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: fluticasone propionate/salmeterol xinafoate combination Drug: Other maintenance Treatments (OMT) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Fluticasone propionate
Salmeterol
Fluticasone
Salmeterol xinafoate
Fluticasone propionate / salmeterol xinafoate
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years [ Time Frame: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) ] [ Designated as safety issue: No ]The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge.
Secondary Outcome Measures:
- Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years [ Time Frame: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) ] [ Designated as safety issue: No ]The number of participants having a COPD-related event was computed during the follow-up and was standardized by dividing by the total days of follow-up in each cohort since patients had different lengths of follow-up. Four types of COPD events were defined: COPD-related hospitalization, emergency room (ER) visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 3 days of the visit, or combined occurrence of any of the aforementioned three types.
- Mean Monthly COPD-related Costs Per Participant [ Time Frame: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) ] [ Designated as safety issue: No ]Cost categories included medical, pharmacy, and total calculated as the sum of medical and pharmacy. Costs were computed during a variable follow-up period and were standardized on a per-month basis. 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.
| Enrollment: | 5677 |
| Study Start Date: | November 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
COPD Patients
Patients over the age of 40 with a COPD-related hospital or ER visit
|
Drug: fluticasone propionate/salmeterol xinafoate combination
Patients filling a prescription for fluticasone/salmeterol combination as index drug
Other Name: Advair (TM)
Drug: Other maintenance Treatments (OMT)
OMT group includes tiotropium, ipratropium alone or in combination with albuterol, inhaled steroids, long acting beta agonists
Other Names:
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Managed care enrollees (aged >40 years) having at least one IP with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one ER visit with primary diagnosis of COPD (index event) during the study period was the target population
Criteria
Inclusion Criteria:
- At least one hospitalization with a primary or secondary diagnosis of COPD or at least one ER visit with a primary diagnosis of COPD
- Initiatiation (prescription) of FSC or non-FSC (i.e. TIO, ICS, LABA, IPR) during peri-index period
- At least 40 years of age
- Continuous eligibility in the pre-index, peri-index, and follow-up periods
Exclusion Criteria
- Presence of exclusionary comorbid conditions during pre-index, peri-index, and follow-up periods: respiratory cancer, cystic fibrosis, fibrosis due to TB, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis
- Controller medication use during peri-index period
- COPD-related hospitalization, ER visit, or physician visit plus OCS/Abx within 3 days of visit during the peri-index period
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01332461 History of Changes |
| Other Study ID Numbers: | 112609 |
| Study First Received: | March 18, 2011 |
| Results First Received: | March 18, 2011 |
| Last Updated: | August 4, 2011 |
| Health Authority: | United States: No Health Authority |
Additional relevant MeSH terms:
|
Chronic Disease Emergencies Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Salmeterol Albuterol Fluticasone Fluticasone, salmeterol drug combination Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Tocolytic Agents Reproductive Control Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013