Boston Early-Onset Chronic Obstructive Pulmonary Disease (COPD) Study
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| ClinicalTrials.gov Identifier: NCT01177618 |
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Recruitment Status
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Recruiting
First Posted
: August 9, 2010
Last Update Posted
: January 18, 2018
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- Study Details
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- No Results Posted
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| Condition or disease |
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| Chronic Obstructive Pulmonary Disease |
Chronic obstructive pulmonary disease (COPD), which is the third leading cause of death in the United States, affects millions of people around the world. COPD, which can include both emphysema and chronic bronchitis, affects the lungs making it very difficult to breathe. Cigarette smoking is the most common risk factor for developing COPD; however, only 15% to 20% of smokers develop COPD in their lifetimes. The onset of COPD also varies greatly from person to person; while some people do not develop respiratory symptoms until later in life, there are others who develop severe COPD at a very early age. Prior research has led to the discovery of the alpha-1 antitrypsin protein deficiency in association with COPD development. This discovery has generated further interest toward studying other genetic factors which may also affect an individual's likelihood of developing COPD. Therefore, the purpose of the Boston Early-Onset COPD study is to gain a better understanding of COPD risk factors in order to establish new possible methods of treatment for people affected by COPD.
For this study we are enrolling individuals affected with severe COPD (52 years old or younger with an FEV1 < 40%) and their family members. Each participant will attend one study visit that involves a respiratory questionnaire, a breathing test, and blood draw. This visit can be completed at the participant's home, in the hospital, or by long distance data collection (phone interview, local breathing tests, and local blood draw with mailed samples), whichever is preferred.
| Study Type : | Observational |
| Estimated Enrollment : | 2000 participants |
| Observational Model: | Family-Based |
| Time Perspective: | Cross-Sectional |
| Official Title: | Genetic Epidemiology of Severe, Early-Onset Chronic Obstructive Pulmonary Disease |
| Study Start Date : | July 1994 |
| Estimated Primary Completion Date : | July 2018 |
| Estimated Study Completion Date : | July 2018 |
| Group/Cohort |
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Probands
Severe, early-onset COPD subjects that bring the family into the study
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Relatives
Relatives of early-onset COPD probands, including first-degree relatives (parents, siblings, and children), second-degree relatives (aunts, uncles, grandparents, half-siblings), spouses, and other affected individuals.
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- No Primary Outcome [ Time Frame: Single Visit for approximately two hours to collect study data and samples ]Since this is an observational study, there are no primary outcomes
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria for Early-Onset COPD Probands:
- Early onset of COPD in individuals younger than 53 years old
- Spirometry results that are indicative of severe COPD (FEV1 < 40% predicted)
- Physician-diagnosed COPD
Exclusion Criteria for Early-Onset COPD Probands:
- Severe alpha-1 antitrypsin deficiency
- Other chronic lung diseases in participants with COPD (except asthma)
- Pregnant
- Any previous lung surgery including lung transplant or lung reduction volume surgery (LVRS); unless prior Pulmonary Function Tests are available
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177618
| Contact: Edwin K. Silverman, M.D., Ph.D. | 617-525-2128 | ed.silverman@channing.harvard.edu |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Cherie Maguire 617-525-2075 rechm@channing.harvard.edu | |
| Contact: Danika Baez 617-525-2128 nhdnb@channing.harvard.edu | |
| Principal Investigator: Edwin K. Silverman, M.D., Ph.D. | |
| Sub-Investigator: Dawn L. DeMeo, M.D. | |
| Sub-Investigator: Craig P. Hersh, M.D. | |
| Principal Investigator: | Edwin K. Silverman, M.D., Ph.D. | Brigham and Women's Hospital |
Publications of Results:
| Responsible Party: | Edwin K. Silverman, Professor of Medicine, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01177618 History of Changes |
| Obsolete Identifiers: | NCT00106444 |
| Other Study ID Numbers: |
1437 R01HL113264 ( U.S. NIH Grant/Contract ) R01HL089856 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 9, 2010 Key Record Dates |
| Last Update Posted: | January 18, 2018 |
| Last Verified: | January 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | For subjects approved for data sharing by our IRB, we will release genome sequencing data through dbGaP. |
Keywords provided by Edwin K. Silverman, Brigham and Women's Hospital:
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Chronic Obstructive Pulmonary Disease COPD Emphysema |
Chronic Bronchitis Genetics Association Studies |
Additional relevant MeSH terms:
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |