Last updated: 11/03/2018 17:24:51
Burden of Frequent and Infrequent Exacerbating Patients with Chronic Obstructive Pulmonary Disease (COPD)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Burden of Frequent and Infrequent Exacerbating Patients with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The clinical course of chronic obstructive pulmonary disease (COPD) is marked by acute episodes of worsening respiratory symptoms including dyspnea, sputum production, sputum purulence, and cough called exacerbations. Exacerbations are the most important contributor to the high morbidity and mortality associated with COPD, which is the third-leading cause of chronic morbidity and mortality in the United States (US). Not all patients experience exacerbations, and the currently available literature on the clinical course for patients who infrequently exacerbate is limited. The current study will evaluate and compare patients who frequently or infrequently exacerbate on the outcomes of subsequent exacerbations, as well as on COPD-related resource use and costs, and all-cause resource use and costs. The objective of this study is to characterize the health care burden of patients with COPD who frequently and infrequently exacerbate. The study is descriptive in nature, and results will be used to generate hypotheses for future studies. The study will use the MarketScan Commercial Claims and Encounters Database (Commercial) and the MarketScan Medicare Supplemental and Coordination of Benefits Database (Medicare). The Commercial database contains integrated medical and pharmacy claims data that are sourced directly from health plans and employers and represent over 35 million commercial lives annually. The Medicare database contains claims data for approximately 3.1 million Medicare-eligible retirees with employer-sponsored Medicare Supplemental plans. The study design is a retrospective, observational cohort study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
COPD-related costs
Timeframe: 2 years, reported annually
COPD-related resource use
Timeframe: 2 years
All-cause costs
Timeframe: 2 years, reported annually
The use of spirometry
Timeframe: 2 years
The rate and frequency of COPD exacerbations
Timeframe: 2 years
All-cause readmission rate
Timeframe: 30 days and 60 days
All-cause resource use
Timeframe: 2 years
COPD-related maintenance drug use
Timeframe: 2 years
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
- At least 1 medical claim with a diagnosis code for COPD in the first or second field between January 1, 2007 to December 31, 2007
- At least 40 years of age in 2007
- Presence of a diagnosis code for any comorbid condition during the study period including pulmonary tuberculosis, sarcoidosis, respiratory cancer, cystic fibrosis, bronchiectasis, extrinsic allergic alveolitis, pneumonociosis and other lung diseases due to external agents, empyema, pleurisy, pneumothorax, abscess of lung and mediastinum, pulmonary congestion and hypostasis, pulmonary fibrosis, other alveolar and parietoalveolar pneumonopathy, lung involvement in conditions classified elsewhere, pulmonary collapse, interstitial and compensatory emphysema, pulmonary eosinophilia, acute edema of lung, unspecified, pulmonary insufficiency following trauma and surgery, allergic bronchopulmonary aspergilliosis, transfusion related acute lung injury, chronic respiratory failure, and other disease of the respiratory system
Inclusion and exclusion criteria
Inclusion criteria:
- At least 1 medical claim with a diagnosis code for COPD in the first or second field between January 1, 2007 to December 31, 2007
- At least 40 years of age in 2007
- Continuously eligible for medical and pharmacy services in 2008, 2009, and 2010
Exclusion criteria:
- Presence of a diagnosis code for any comorbid condition during the study period including pulmonary tuberculosis, sarcoidosis, respiratory cancer, cystic fibrosis, bronchiectasis, extrinsic allergic alveolitis, pneumonociosis and other lung diseases due to external agents, empyema, pleurisy, pneumothorax, abscess of lung and mediastinum, pulmonary congestion and hypostasis, pulmonary fibrosis, other alveolar and parietoalveolar pneumonopathy, lung involvement in conditions classified elsewhere, pulmonary collapse, interstitial and compensatory emphysema, pulmonary eosinophilia, acute edema of lung, unspecified, pulmonary insufficiency following trauma and surgery, allergic bronchopulmonary aspergilliosis, transfusion related acute lung injury, chronic respiratory failure, and other disease of the respiratory system -
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2012-24-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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