Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations

NCT00774176 | Completed DMC

• 1 other identifier: PA DOH RFA-02-07-20
• Study Type: observational
• Target: 1,066
• Locations: 1 country
• Sites: 3

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.

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.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  2 years

Study Arms (3)

1

Phase 1 \& Gene Expression:Hospitalized COPD exacerbators

2

Phase 2: COPD group

3

Genetic Association Studies: COPD and Healthy Controls

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Phase 1: inpatients hospitalized for COPD exacerbations Phase 2: Moderate to severe COPD

You may qualify if:

• Phase 1 \& Gene Expression: --Current hospitalization for COPD exacerbation
• Phase 1 \& 2: COPD \& ONE of the following criteria:
• History of hospitalization for COPD exacerbation, OR
• Currently on supplemental oxygen, OR
• History of evaluation for lung transplant or LVRS, OR
• \>/= 6 months post-LVRS
• Phase 1 or 2:
• Current or former smoker, \>/= 20 pack-yr. smoking history
• FEV1 \</= 70%; FEV1/FVC \</= 70%
• Life expectancy of \> 6 months

You may not qualify if:

• \< 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%

Sponsors & Collaborators

• Temple University: lead
• Pennsylvania Department of Health: collaborator

Study Sites (3)

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (1)

• 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.

  PMID: 27814717 DERIVED

Related Links

• Publication of results: PMID: 26259074

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Gerard J Criner, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: October 17, 2008
• Study Start: June 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)