Outcomes Associated With Early or Delayed Maintenance Treatment Post-Chronic Obstructive Pulmonary Disease Exacerbation
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ClinicalTrials.gov Identifier: NCT01431911 |
Recruitment Status
:
Completed
First Posted
: September 12, 2011
Last Update Posted
: May 16, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Pulmonary Disease, Chronic Obstructive | Drug: Early maintenance treatment Drug: Delayed Maintenance treatment |
Study period for this analysis will range from January 2003 through June 2009. Patients with at least one COPD exacerbation will be selected as the initial population. Three types of COPD exacerbations will be identified: 1) hospitalization with a primary discharge diagnosis code for COPD, 2) an emergency department (ED) visit with a primary diagnosis code for COPD, 3) physician visit with a dispensing of oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit. Only the first two will be selected as index exacerbations, which is defined as the first chronologically occurring exacerbation for a patient. For hospitalization exacerbations the discharge date of the hospitalization will be the index date and for ED exacerbations the date of the visit will be the index date. The pre-index period will be defined as the 1-year period before index date and the post-index period will be defined as 1-year period after index date. The enrollment period will thus range from January 1, 2004 through June 30, 2008. The post-index period will be used to identify the date of receipt of prescription for first COPD maintenance medication. This date of receipt will be used to compute the time to start maintenance treatment. Maintenance treatment refers to the use of controller medications.
Specifically the study hypothesis for the primary outcome being tested was:
Ho: There is no difference in risk of COPD-related hospitalization/ED visit between early and delayed cohorts Ha: There is a difference in risk of COPD-related hospitalization/ED visit between early and delayed cohorts
Hypothesis for the key secondary outcome of COPD-related costs that was tested was:
Ho: There is no difference in COPD-related costs between early and delayed cohorts Ha: There is a difference in COPD-related costs between early and delayed cohorts
Study Type : | Observational |
Actual Enrollment : | 3806 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Outcomes Associated With Early or Delayed Maintenance Treatment Post-Chronic Obstructive Pulmonary Disease Exacerbation |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | March 2011 |
Group/Cohort | Intervention/treatment |
---|---|
Patients diagnosed with COPD
Patients diagnosed with COPD using ICD codes with a COPD-related exacerbation and receiving maintenance therapy
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Drug: Early maintenance treatment
Various classes of COPD maintenance treatment initiated within 30 days post index COPD exacerbation (hospitalization/ED visit)
Drug: Delayed Maintenance treatment
Various classes of COPD maintenance treatment initiated after 30 days post index COPD exacerbation (hospitalization/ED visit)
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- COPD hospitalization/ED visit [ Time Frame: Up to 6 years (January 1, 2003 through June 30, 2009) ]Risk and number of COPD exacerbations will be computed in the post-index period. Hospitalization with a primary discharge diagnosis code (ICD code 491.xx, 492.xx, and 496.xx) for COPD. ED visit will be defined as COPD related if accompanied by diagnosis code for COPD.
- COPD-related ED visit [ Time Frame: Up to 6 years (January 1, 2003 through June 30, 2009) ]The risk and proportion of patients with a COPD-related exacerbation requiring ED visit was defined as a COPD-related ED visit.
- COPD-related hospitalization [ Time Frame: Up to 6 years (January 1, 2003 through June 30, 2009) ]risk and number of COPD hospitalizations will be computed in the post-index period. Hospitalization with a primary discharge diagnosis code (ICD code 491.xx, 492.xx, and 496.xx) for COPD will be captured.
- COPD-related Phy+Rx visit [ Time Frame: January 1, 2003 through June 30, 2009 (up to 6 years) ]Risk and number of COPD-related physician office visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit
- COPD related Costs [ Time Frame: January 1, 2003 through June 30, 2009 (up to 6 years) ]COPD related medical, pharmacy and total costs. Costs were standardized to 2009 US dollars (USD) using consumer price index for US medical care.

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- at least 40 years of age,
- continuously enrolled for medical and pharmacy benefits during their pre- and post-period
- diagnosis of COPD (ICD 491.xx, 492.xx, 496.xx)
Exclusion Criteria:
- Patients were excluded if they had MTx in the pre-index period (to ensure inclusion of MTx-naïve patients) or if they received their first MTx during 181 to 365 days of the post-period (as dispensing of MTx unlikely to be related to the index exacerbation).
- Additionally, patients were excluded if they had any of the following comorbid conditions anytime during the study period: respiratory cancer, cystic fibrosis, fibrosis due to, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, or sarcoidosis, and
- also if they had other doses (unapproved in the US) of fluticasone propionate-salmeterol xinafoate combination (100/50 mcg or 500/50 mcg) or budesonide dipropionate-formoterol fumarate fixed dose combination (any dose).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431911
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01431911 History of Changes |
Other Study ID Numbers: |
113898 |
First Posted: | September 12, 2011 Key Record Dates |
Last Update Posted: | May 16, 2017 |
Last Verified: | May 2017 |
Additional relevant MeSH terms:
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Chronic Disease |
Disease Progression Respiratory Tract Diseases Disease Attributes Pathologic Processes |