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Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00774176
Acronym
PA-SCOPE
Enrollment
1066
Registered
2008-10-17
Start date
2004-06-30
Completion date
2008-05-31
Last updated
2017-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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.

Brief summary

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.

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

Interventions

None listed

Sponsors

Pennsylvania Department of Health
CollaboratorOTHER_GOV
Temple University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

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%

Design outcomes

Primary

MeasureTime frame
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.Phase 1 is up to 10 weeks. Phase 2 is up to 2 years.

Secondary

MeasureTime frame
Phase 2 also documents the number, severity, & subject reporting of exacerbations, spirometry changes,& quality of life.2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026