Status:
COMPLETED
Aerosol Cyclosporine in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
University of Pittsburgh
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
45-70 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blinded, Phase I dose escalation-deescalation protocol (DEP) of cyclosporine inhalation solution in patients with Gold Stage III chronic obstructive pulmonary disease. Th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Undiagnosed pulmonary nodule requiring diagnostic evaluation
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00783107
Start Date
October 1 2007
End Date
September 1 2009
Last Update
December 11 2012
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213