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

This study has been completed.
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00774176
First received: January 4, 2008
Last updated: August 3, 2011
Last verified: October 2008
History of Changes
  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
Official Title: Pennsylvania Study of Chronic Obstructive Pulmonary Exacerbations (PA-SCOPE)

Resource links provided by NLM:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase 2 also documents the number, severity, & subject reporting of exacerbations, spirometry changes,& quality of life. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Ancillary studies collect blood specimens for gene expression and genetic factors.


Estimated Enrollment: 1000
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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Gerard Criner, M.D., Temple University
ClinicalTrials.gov Identifier: NCT00774176     History of Changes
Other Study ID Numbers: PA DOH RFA-02-07-20
Study First Received: January 4, 2008
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013