Last updated: 11/03/2018 17:24:51

Burden of Frequent and Infrequent Exacerbating Patients with Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
114937
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
  • Drug: Xanthenes
  • Drug: ICS+LABA
  • Drug: Inhaled corticosteroids (ICS)
  • Drug: Long-acting Beta Agonists (LABA)
  • Drug: Anticholinergics
  • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, fluticasone propionate/salmeterol/norflurane, norflurane, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    September 2012 to October 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    none
    • 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

    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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