Clinical trial NCT00774176: Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations
Official title: Pennsylvania Study of Chronic Obstructive Pulmonary Exacerbations (PA-SCOPE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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.
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
First posted: 2008-10-17
Enrollment: 1066
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Phase 1: inpatients hospitalized for COPD exacerbations Phase 2: Moderate to severe COPD

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

Eligibility 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%

Primary outcomes:
measure: 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.
timeFrame: Phase 1 is up to 10 weeks. Phase 2 is up to 2 years.
Secondary outcomes:
measure: Phase 2 also documents the number, severity, & subject reporting of exacerbations, spirometry changes,& quality of life.
timeFrame: 2 years
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Gerard J Criner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Busch R, Qiu W, Lasky-Su J, Morrow J, Criner G, DeMeo D. Differential DNA methylation marks and gene comethylation of COPD in African-Americans with COPD exacerbations. Respir Res. 2016 Nov 5;17(1):143. doi: 10.1186/s12931-016-0459-8.