Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Pittsburgh
Age
45–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age between 45 and 70 years.
A confirmed diagnosis of COPD, Gold Stage III, using current accepted diagnostic criteria, including clinical/laboratory findings, pulmonary function tests, and appropriate history to exclude other disorders that could explain their lung disease.
Subjects agree to maintain a stable medication regimen in the absence of a disease flare
ECOG performance status of 0, 1, or 2.
pCO2 \< 45 mm Hg, room air oxyhemoglobin saturation \> 85%
A willingness to participate in all portions of the protocol, including serial bronchoscopy, requisite surveillances, and ancillary immunologic studies in follow-up visits at this institution.
For woman of childbearing age, a negative pregnancy test, and a willingness to use two methods of contraception, or abstinence, and undergo monthly pregnancy testing.
Elevated T-cell cytokine gene expression, defined as baseline values \> the mean of the pilot Gold 0-1 study population for one variable (CD4+IL-2 \>23%, CD8+IFN-g \>17%, CD8+MHC \> 6%, or CD8 TGF-b).
An ability and willingness to provide written informed consent.
You may not be if
Three, or more exacerbations of lower respiratory disease in the past year requiring systemic corticosteroids, or one exacerbation requiring hospitalization in the past 6 months
Intubation for COPD, or other cause of respiratory failure in the past year
Use of immunosuppressive therapy (including oral prednisone), other than aerosolized corticosteroids, anytime within three months prior to participation
Evidence for an opportunistic infection/colonization of the airways, i.e., non-bacterial
Use of aerosolized corticosteroids with an inability to maintain inhaled corticosteroid therapy dosing without change during the study interval
Evidence for systemic illness including hematologic disorders (defined by an absolute neutrophil count (ANC) \< 4000 /mL and platelets \< 120,000/mL), renal insufficiency (serum creatinine \> 2.0 mg/dL), cirrhosis, or hepatic insufficiency (total bilirubin, or alkaline phosphatase \> 1.5 x normal, SGOT, or SGPT \> 1.2 x normal values), or a coagulopathy (INR \> 1.4), seizure disorder.
Evidence for systemic abnormal renal function manifested by uncontrolled hypertension (systolic blood pressure \> 160mmHg or diastolic blood pressure \>90mmHg), hyperkalemia (serum creatinine \> 5.0 meq/dl, and/or elevated serum creatinine above the normal range for the subject's age.
Evidence of coronary artery disease by history, e.g., angina or history of myocardial infarction within the past 12 months, unless corrected by CABG within \< 5 years, and asymptomatic since
Pregnant or breast feeding females or women of childbearing potential not practicing birth control during and for 6 months following treatment, or fertile and sexually active males unwilling to use contraceptive techniques during and for 6 months following treatment
Positive HIV, or hepatitis B or C serology, or another active infection
Current or past history of cancer excluding basal or squamous cell skin cancer
Weight loss \> 10% usual body weight over the past 6 months or a BMI \< 18
Known hypersensitivity or allergy to propylene glycol, CsA, or lidocaine
Concurrent enrollment or participation within the prior month in other clinical trials
Greater than 15% or 200 ml reduction in FEV1 post test dose propylene glycol administration
Known medical or psychological condition (severe personality disorder or mental illness) that would not permit the subject to complete the trial or sign informed consent
Autoimmune disorders or other disorders with suspected systemic immune involvement
Active smoking history or urinary cotinine \> 2.
Hypersensitivity to midazolam or narcotics which would not allow bronchoscopy sedation
