Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations - Full Text View

Sponsors and Collaborators:	Temple University Pennsylvania Department of Health
Information provided by:	Temple University
ClinicalTrials.gov Identifier:	NCT00774176

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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Observational
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. ] [ 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

Biospecimen Description:

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

Estimated Enrollment:	1000
Study Start Date:	August 2004
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 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

Contacts

Contact: Carla L Grabianowski, BSN

215-707-1359

breathe@temple.edu

Locations

United States, Pennsylvania
Temple University School of Medicine	Recruiting
Philadelphia, Pennsylvania, United States, 19140
Principal Investigator: Gerard J Criner, MD
Western Pennsylvania Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Debbie Fiehler, BSN 412-687-5573
Principal Investigator: Paul Fiehler, MD
Lancaster General Hospital	Recruiting
Lancaster, Pennsylvania, United States, 17604
Contact: Amy Pixley, BSN 717-544-5695
Principal Investigator: Steve Lando, MD

Sponsors and Collaborators

Temple University

Pennsylvania Department of Health

Investigators

Principal Investigator:

Gerard J Criner, MD

Temple University

More Information

PA-SCOPE Website This link exits the ClinicalTrials.gov site

Responsible Party:	Temple University ( Gerard Criner, M.D. )
Study ID Numbers:	PA DOH RFA-02-07-20
Study First Received:	January 4, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00774176
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.

Study placed in the following topic categories:

Pulmonary Emphysema
Emphysema
Lung Diseases, Obstructive
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Healthy
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009