Alpha-1 Antitrypsin DeficiencyPFTNCT01419158
Prevalence of Alpha-1 Antitrypsin Deficiency in Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Alpha-1 Antitrypsin Deficiency and Chronic Obstructive Pulmonary Disease, run by Alpha-1 Foundation at 19 sites in 2 countries.
Trial summary
Alpha-1 antitrypsin deficiency (AATD) is considered a rare genetic cause of chronic obstructive pulmonary disease (COPD) and liver disease. Recent data has suggested that AATD is not as rare as originally thought and undetected AATD may account for COPD in some patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alpha-1 Antitrypsin Deficiency, Chronic Obstructive Pulmonary Disease
- How many people
- 3,457 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Jan 2008to Jan 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals reporting for pulmonary function testing who meet criteria for the diagnosis of chronic obstructive pulmonary disease
Who may be able to join
- Male and female adults at least 18 years of age able to understand and consent to the procedures of this protocol.
- All races and ethnicities will be considered for this study.
- Post-bronchodilator values for pulmonary function tests on the day of enrollment with an FEV1 < 80% of predicted and FEV1/FVC < 70% (at least GOLD stage II).
- Subjects who have been tested for Alpha-1 in the past but do not know their genotype or phenotype may be included in this study.
- Note: For the inclusion criteria the investigators will use the patient's GOLD status, based on percent predicted (FEV1 < 80% of predicted); however, after sending the absolute value of FEV1 to the Data Coordinating Center (DCC) the DCC will calculate the percent predicted using a standardized formula (NHANES III). For sites that do not use this predicted formula, the results obtained at the DCC may differ from those used for subject enrollment. (For example, a subject found to have an FEV1 of <80% at the study site could have an FEV1 > 80% when the DCC recalculates it). Enrollment will be based on the percent predicted at each study site. If necessary, the data from this small number of outliers will be analyzed separately.
Who cannot join
- Subjects in whom post-bronchodilator spirometry is not performed.
- Subjects whose ordering physician has specifically requested that his patients not be considered for enrollment.
- Patients who have been tested for Alpha-1 in the past and know their genotype or phenotype.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
Emory Crawford Long Hospital
Atlanta, Georgia, 30308
Emory University
Atlanta, Georgia, 30322
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Atlanta VA Medical Center
Decatur, Georgia, 30033
National Jewish Medical and Research Center
Denver, Colorado, 80206
University of Florida (Gainesville)
Gainesville, Florida, 32610
University of Florida (Jacksonville)
Jacksonville, Florida, 32209
University of California Los Angeles
Los Angeles, California, 90095
University of Miami
Miami, Florida, 33101
Miami VA Medical Center
Miami, Florida, 33125
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
Cleveland Clinic Florida
Weston, Florida, 33332
Puerto Rico1 site
San Juan City Hospital
Centro Medico Metropolitano, San Juan, 09036
About this study
Official title: Targeted Detection of Alpha-1 Antitrypsin Deficiency in Patients Referred for Pulmonary Function Testing
Alpha-1 antitrypsin deficiency (AATD) is considered a rare genetic cause of chronic obstructive pulmonary disease (COPD) and liver disease. Recent data has suggested that AATD is not as rare as originally thought and undetected AATD may account for COPD in some patients. This study was designed to evaluate the frequency of undetected AATD in a population reporting to academic pulmonary function testing facilities who meet criteria for the diagnosis of COPD. All individuals meeting GOLD criteria for COPD will be consented and offered free testing for AATD. The results will help identify the percent of those with COPD who have undetected AATD.
- Keywords
- Alpha-1 antitrypsin, Alpha-1 antitrypsin deficiency, Chronic obstructive pulmonary disease
- Medical subject headings
- alpha 1-Antitrypsin Deficiency, Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha-1 Antitrypsin DeficiencyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha-1 Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert A Sandhaus, M.D., Ph.D., Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419158
- Sponsor's protocol ID
- PFT-001
- Acronym
- PFT
- Status last verified
- Sep 2011
- First submitted
- 16 Aug 2011
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Detection of Alpha-1 Antitrypsin Deficiency in Patients Referred for Pulmonary Function Testing
- ClinicalTrials.gov ID
- NCT01419158
- Acronym / sponsor ID
- PFT / PFT-001
- Keywords
- Alpha-1 antitrypsin, Alpha-1 antitrypsin deficiency, Chronic obstructive pulmonary disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,457 participants (actual)
- Lead sponsor
- Alpha-1 FoundationUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Aug 2011 (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.
Alpha-1 antitrypsin deficiency (AATD) is considered a rare genetic cause of chronic obstructive pulmonary disease (COPD) and liver disease. Recent data has suggested that AATD is not as rare as originally thought and undetected AATD may account for COPD in some patients. This study was designed to evaluate the frequency of undetected AATD in a population reporting to academic pulmonary function testing facilities who meet criteria for the diagnosis of COPD. All individuals meeting GOLD criteria for COPD will be consented and offered free testing for AATD. The results will help identify the percent of those with COPD who have undetected AATD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals reporting for pulmonary function testing who meet criteria for the diagnosis of chronic obstructive pulmonary disease
Key inclusion criteria (5 listed)
- Male and female adults at least 18 years of age able to understand and consent to the procedures of this protocol.
- All races and ethnicities will be considered for this study.
- Post-bronchodilator values for pulmonary function tests on the day of enrollment with an FEV1 < 80% of predicted and FEV1/FVC < 70% (at least GOLD stage II).
- Subjects who have been tested for Alpha-1 in the past but do not know their genotype or phenotype may be included in this study.
- Note: For the inclusion criteria the investigators will use the patient's GOLD status, based on percent predicted (FEV1 < 80% of predicted); however, after sending the absolute value of FEV1 to the Data Coordinating Center (DCC) the DCC will calculate the percent predicted using a standardized formula (NHANES III). For sites that do not use this predicted formula, the results obtained at the DCC may differ from those used for subject enrollment. (For example, a subject found to have an FEV1 of <80% at the study site could have an FEV1 > 80% when the DCC recalculates it). Enrollment will be based on the percent predicted at each study site. If necessary, the data from this small number of outliers will be analyzed separately.
Key exclusion criteria (3 listed)
- Subjects in whom post-bronchodilator spirometry is not performed.
- Subjects whose ordering physician has specifically requested that his patients not be considered for enrollment.
- Patients who have been tested for Alpha-1 in the past and know their genotype or phenotype.
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
Not reported in the source record.
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 19 Jan 2012.
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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.
Robert A Sandhaus, M.D., Ph.D. principal investigator
National Jewish Health
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alpha-1 Antitrypsin Deficiency and Chronic Obstructive Pulmonary Disease, run by Alpha-1 Foundation at 19 sites in 2 countries.
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 5 inclusion and 3 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 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Puerto Rico. 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.
Where can I read the original study information?
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 19 Jan 2012.