Chronic Obstructive Pulmonary DiseasePA-SCOPENCT00774176
Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations
An observational study of Chronic Obstructive Pulmonary Disease, run by Temple University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 1,066 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2004to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Phase 1: inpatients hospitalized for COPD exacerbations Phase 2: Moderate to severe COPD
Who may be able to join
- 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
Show all 10Show fewer
- Phase 1 or 2:
- Current or former smoker, >/= 20 pack-yr. smoking history
- FEV1 </= 70%; FEV1/FVC </= 70%
- Life expectancy of > 6 months
Who cannot join
- < 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%
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Pennsylvania Study of Chronic Obstructive Pulmonary Exacerbations (PA-SCOPE)
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.
Read the 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
- 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.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Phase 1 \& Gene Expression:Hospitalized COPD exacerbators | |
| 2 | Phase 2: COPD group | |
| 3 | Genetic Association Studies: COPD and Healthy Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startJun 2004
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,066 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
- Investigators
- Gerard J Criner, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774176
- Sponsor's protocol ID
- PA DOH RFA-02-07-20
- Acronym
- PA-SCOPE
- Status last verified
- Jun 2017
- First submitted
- 4 Jan 2008
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27814717
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pennsylvania Study of Chronic Obstructive Pulmonary Exacerbations (PA-SCOPE)
- ClinicalTrials.gov ID
- NCT00774176
- Acronym / sponsor ID
- PA-SCOPE / PA DOH RFA-02-07-20
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,066 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- Jun 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Phase 1 \& Gene Expression:Hospitalized COPD exacerbators |
| 2 | – | –Phase 2: COPD group |
| 3 | – | –Genetic Association Studies: COPD and Healthy Controls |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Phase 1: inpatients hospitalized for COPD exacerbations Phase 2: Moderate to severe COPD
Key inclusion criteria (10 listed)
- Phase 1 \& Gene Expression: --Current hospitalization for COPD exacerbation
- Phase 1 \& 2: COPD \& ONE of the following criteria:
- Phase 1 or 2:
Key exclusion criteria (4 listed)
- < 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Phase 2 also documents the number, severity, & subject reporting of exacerbations, spirometry changes,& quality of life.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Derived from this study: PubMed 27814717Busch 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.
- Publication of results: PMID: 26259074Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard J Criner, MD principal investigator
Temple University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Temple University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Phase 1 is up to 10 weeks. Phase 2 is up to 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00774176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.