Alpha-1 Foundation, AARC Cooperate On Study To Test 5,000 COPD Patients For Alpha-1

Some 5,000 COPD patients will be tested
to determine the prevalence of Alpha-1 Antitrypsin Deficiency (Alpha-1) in
a study marking a major cooperative effort between the Alpha-1 Foundation
and the American Association for Respiratory Care (AARC).


The principal investigator is Robert A. Sandhaus, MD, PhD, of the
Division of Pulmonary Medicine, National Jewish Medical and Research Center
in Denver. Sandhaus is also the Clinical Director of the Alpha-1
Foundation.



According to Sandhaus, "If the current literature is correct, the study
should identify about 50 to 100 individuals who are unaware they have COPD
due to Alpha-1. In addition, the study should identify about 300 people who
are carrying a single abnormal Alpha-1 gene. All will be counseled about
the potential risk to their children and family members."



Sandhaus points to an intriguing possibility. "If this study confirms
what much smaller studies have suggested about Alphas hidden in the COPD
population, there could be as many as 400,000 individuals in the US who
have lung disease due to Alpha-1 and don't know it."



More than 12 million people have been diagnosed with COPD (Chronic
Obstructive Pulmonary Disease), an umbrella term that includes emphysema
and chronic bronchitis. COPD is the 4th leading cause of death in the
United States, and is expected to be the third leading killer by 2020.
Alpha-1, sometimes called "genetic COPD," is the most common known genetic
risk factor for emphysema.



Sandhaus believes the study will demonstrate the effectiveness of using
respiratory therapists to perform significant pulmonary clinical research.



"Respiratory therapists will have a critical role as more genetic
factors (in lung, airway and sleep disorders) are identified," said Alpha-1
Foundation President and CEO John W. Walsh. "The expanding role of the RT
in supporting the physician will accelerate early detection and access to
appropriate care."



Thomas Kallstrom, AARC Chief Operating Officer, is the study
coordinator for the AARC. "The involvement of respiratory therapists in
this process is a natural relationship," Kallstrom said. "We're proud to be
part of this monumental study."



The Alpha-1 Foundation and the AARC cooperated to propose, design and
run the study, which will enroll 5,000 people at 15 academic sites around
the United States. To be eligible, a patient must have been referred for
pulmonary function testing at the site. Any patient meeting COPD criteria
(as defined by GOLD, the Global Initiative for Chronic Obstructive Lung
Disease) will be offered enrollment in the study.



The study requires only about 30 minutes of the subject's time, and
participants will receive the results. If they are positive for Alpha-1,
they will receive educational information about the condition and will be
encouraged to call a toll-free number to speak with the Alpha-1 genetic
counselor at the Medical University of South Carolina.



Epidemiology and AAT genotyping for the study will be done at the
University of Florida Alpha-1 Genetics Laboratory run by Mark L. Brantly,
MD. Data coordination and statistical analysis will be done by James
Murphy, PhD, at National Jewish.



Jorge Zamudio, MD, is the Alpha-1 Foundation coordinator.



The study is supported in part by an unrestricted charitable
contribution from Talecris Biotherapeutics.


Alpha-1 Foundation

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