The Emphysema/COPD Research Center will enroll up to 3000 subjects at the University of
Pittsburgh. The experimental procedures that will be conducted as a part of the Emphysema
Research Registry include gathering basic personal information (e.g., name, address,
phone number, etc.), asking basic screening questions (which may involve the examination
of past, current, and future medical records with an authorized release and the
collection of personally identifiable medical record information), completing two
breathing questionnaires, performing screening lung function tests to determine breathing
capacity and blood oxygen levels, to have blood drawn, to complete a measurement of leg
muscle strength, and to have a measurement of body fat.
The breathing questionnaires are known as the St. George's Respiratory Questionnaire
(SGRQ), the Medical Research Council Dyspnea Questionnaire (MRCDQ) and COPD assessment
Test (CAT). These are paper and pencil questionnaires that inquire about respiratory
symptoms, quality of life, and shortness of breath.
Breathing tests are routine clinical tests that measure lung function; spirometry
(measures the ability to move air in and out of the lungs), lung volumes (measures the
amount of air trapped in the lungs), diffusing capacity (measures how well lungs transfer
oxygen to blood), forced oscillometry testing (measures respiratory resistance), and
pulse oximetry (measures blood oxygen levels). In addition, subjects will be asked to
inhale two puffs of albuterol, which is an inhaled medicine (bronchodilator) that may
open up breathing passages, and to repeat some of the breathing tests.
The initial blood work will consist of two samples. The first sample will examine routine
tests such as blood chemistries (such as sodium and potassium), hemoglobin, blood count,
and blood sugar. The second sample will involve DNA testing. The DNA in your cells is
what determines your genetic makeup. The DNA studies that will be done for this Research
Registry will be restricted to studies of genetics associated with COPD. The total amount
of blood drawn will be 5 tablespoons or less. A separate consent form, Consent 2,
addresses this second blood draw in detail. In addition to the initial blood draw, the
participant will be asked to contact the center when they are experiencing a COPD
exacerbation (increased cough, change in sputum, shortness of breath, etc.). At that
time, the participant will be asked to either come to the clinic or allow a study
coordinator to go to them and obtain an additional sample of blood. The total amount of
this sample will be less than 2 tablespoons. Biologic samples (serum plasma) will be
under the control of the principal investigator of this research project. To protect
confidentiality, all personal identifiers (i.e. name, social security number, birth date)
will be removed (de-identified) and replaced with a specific code number. The information
linking these code numbers to the corresponding subjects' identities will be kept in a
separate, secure location. The investigators on this study will keep the samples
indefinitely. Biological samples may (or will or will not) be given to investigators
outside of UPMC or may be utilized in future studies.
Leg muscle strength will be measured using an isokinetic dynamometer (MERAC, Universal,
Cedar Rapids, IA) in all subjects. Strength will be measured as peak angular force
(Newton-m) generated at an angular velocity of 60º/sec during three maximal continuous
repetitions. Subjects will be provided standardized instructions and perform practice
maneuvers to ensure smooth torque curves.
Body fat testing, also known as Fat Free Mass (FFM) testing, will be measured using a
single frequency bioelectrical impedance method in the supine position, as the mean of
two measurements (one on each side of the body), using equipment previously used by the
Emphysema Research Center (BIA 101/s RJL-Systems, Detroit, MI). The FFM index will be
calculated by dividing FFM by height in meters2 as an accurate measure of muscle mass.
All study procedures including Informed Consent, breathing questionnaires, breathing
tests, blood work, leg muscle strength testing, and body fat testing will be conducted at
the Emphysema/COPD Research Center, located in Suite 1211, Kaufmann Building. The
informed consent usually takes 30 minutes, the Patient Data Form will require 5 minutes
to fill out, the two breathing questionnaires will take 15 minutes, the screening lung
function tests usually take less than 1 hour, the blood work will take 15 minutes, the
leg muscle strength testing will take 10 minutes, and the body fat testing will take 5
minutes.
The information from each subject will be entered into the Emphysema Research Registry.
The information will be held here until a research protocol is developed or an outside
investigator approaches Dr. Frank C. Sciurba. The information gathered (basic personal
information, basic screening questions, breathing questionnaires, screening lung function
tests, blood work, leg muscle strength, and body fat) will be updated periodically, based
on investigator need.
