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Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations (PA-SCOPE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00774176
First Posted: October 17, 2008
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
Temple University
  Purpose
The overall purpose of PA-SCOPE is to determine why black and rural residents of Pennsylvania might be at higher risk for deadly, debilitating, and costly hospitalizations for chronic obstructive pulmonary disease (COPD)— and then to show that repeat acute exacerbations in high-risk patients can be reduced with one simple intervention. We believe that 1) COPD patients who are black or who live in rural areas of Pennsylvania are at higher risk of acute exacerbations requiring hospitalization and 2) this elevated risk can be reduced with one simple intervention: access to a 1-800 Temple Call Center where patients can get immediate customized advice on managing COPD exacerbations in their early stages. We will test these beliefs in PA-SCOPE. The collaborators with Temple University Hospital on the PA-SCOPE project are Lancaster General Hospital, Western Pennsylvania Hospital, and the Philadelphia College of Osteopathic Medicine.

Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: Pennsylvania Study of Chronic Obstructive Pulmonary Exacerbations (PA-SCOPE)

Further study details as provided by Temple University:

Primary Outcome Measures:
  • Phase 1 identifies the demographic & genetic factors affecting inpatient hospitalization for COPD exacerbation.Phase 2 documents the number of physician & ER visits, hospitalizations & death related to exacerbations. [ Time Frame: Phase 1 is up to 10 weeks. Phase 2 is up to 2 years. ]

Secondary Outcome Measures:
  • Phase 2 also documents the number, severity, & subject reporting of exacerbations, spirometry changes,& quality of life. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Ancillary studies collect blood specimens for gene expression and genetic factors.

Enrollment: 1066
Study Start Date: June 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Phase 1 & Gene Expression:Hospitalized COPD exacerbators
2
Phase 2: COPD group
3
Genetic Association Studies: COPD and Healthy Controls

Detailed Description:
  • Overall objective: To determine why African American and rural residents of Pennsylvania might be at higher risk for deadly, debilitating, and costly hospitalizations for COPD—and to show that repeat acute exacerbations in high-risk patients can be reduced with one simple intervention--access to a 1-800 Temple Call Center phone number where patients can get immediate customized advice on managing COPD exacerbations in their early stages.
  • Phase 1: To compare and contrast the influence of race and geographic location in COPD exacerbation in relation to severity, comorbidities, treatment patterns, infection rate. To identify potential risk factors for COPD exacerbations leading to hospitalization.
  • Phase 2: To reduce hospitalizations and deaths due to COPD exacerbations and to improve patient quality of life, lung function, and everyday activity levels
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Phase 1: inpatients hospitalized for COPD exacerbations Phase 2: Moderate to severe COPD
Criteria

Inclusion Criteria:

  • Phase 1 & Gene Expression: --Current hospitalization for COPD exacerbation
  • Phase 1 & 2: COPD & ONE of the following criteria:

    1. History of hospitalization for COPD exacerbation, OR
    2. Currently on supplemental oxygen, OR
    3. History of evaluation for lung transplant or LVRS, OR
    4. >/= 6 months post-LVRS
  • Phase 1 or 2:

    1. Current or former smoker, >/= 20 pack-yr. smoking history
    2. FEV1 </= 70%; FEV1/FVC </= 70%
    3. Life expectancy of > 6 months

Exclusion Criteria:

  • < 20 pack-yr. smoking history
  • Diagnosis of pulmonary fibrosis, bronchiectasis, mediastinal mass, or presence of a pulmonary mass
  • Asthma
  • FEV1 > 70% or FEV1/FVC >70%
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00774176


Locations
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Temple University
Pennsylvania Department of Health
Investigators
Principal Investigator: Gerard J Criner, MD Temple University
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00774176     History of Changes
Other Study ID Numbers: PA DOH RFA-02-07-20
First Submitted: January 4, 2008
First Posted: October 17, 2008
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Temple University:
Chronic Obstructive Pulmonary Disease
COPD
COPD Exacerbation
Genetic markers COPD
Gene expression in COPD exacerbations
COPD Exacerbation Symptom Reporting
COPD Exacerbation Disease Management
COPD Treatment
Breathing disorders
Emphysema
COPD with Healthy Control comparators for genetic association studies.

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases