Phase II Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Mucoid Exopolysaccharide Pseudomonas Aeruginosa Immune Globulin for Cystic Fibrosis

PROTOCOL ENTRY CRITERIA:

Disease Characteristics

• Cystic fibrosis (CF) documented by pilocarpine iontophoresis sweat chloride greater than 60 mEq/L FEV1 30%-80% of predicted and within 20% of maximum values obtained in 12 months prior to entry Able to expectorate at least 1 g of sputum within 3 hours at screening
• Mucoid Pseudomonas aeruginosa colonization documented in at least 2 serial expectorated sputum cultures in the year prior to entry Screening specimen meets requirement for 1 culture
• Documented exacerbation of respiratory tract infection At least 1 hospitalization and/or course of parenteral or nebulized antibiotic therapy in each of the 2 years prior to entry
• At least 2 serial spirometry tests over at least 6 months prior to entry FEV1 range no more than 15% relative to maximum value
• None of the following within 6 months prior to entry: Pseudomonas (Burholderia) cepacia or atypical mycobacteria in respiratory tract Pulmonary hemorrhage with greater than 5% drop in hematocrit Pneumothorax requiring chest tube
• No life-threatening CF sequelae, e.g.: Severe cirrhosis with ascites or bleeding Severe distal intestinal obstruction syndrome requiring cessation of oral intake Poorly controlled insulin-dependent diabetes with acetonuria

Prior/Concurrent Therapy

• No concurrent participation in other investigational protocols
• No prior investigational P. aeruginosa vaccine
• At least 45 days since immune globulin or antibacterial monoclonal antibody
• At least 4 weeks since investigational drugs
• At least 2 weeks since systemic glucocorticoids
• No requirement for systemic steroids during first 2 weeks of study

Patient Characteristics

• Renal: Creatinine less than 2 mg/dL (1.5 mg/dL in patients under 50 kg)
• No proteinuria
• No hematuria
• Cardiovascular: No cor pulmonale or other heart disease requiring chronic diuretics, afterload reduction, or cardiac glycoside therapy (e.g., digoxin)
• Immunologic: Endogenous immunoreactive IgA at least 5 mg/dL
• No hypersensitivity to immune globulin or human albumin
• No primary or acquired immunodeficiency disease
• Other: No clinical test abnormal on repeat and inconsistent with CF
• No smoking 1 month prior to and during study
• No suspected drug or alcohol abuse within 1 year prior to entry
• No severe illness that precludes protocol participation
• No disability, condition, or geographical location that would impair compliance
• No psychiatric disorder, intellectual deficiency, or other condition that would limit informed consent
• Negative pregnancy test required of fertile women
• Medically acceptable contraception required of fertile women
• Participating investigators, sub-investigators, study coordinators, and employees of participating investigators or immediate family members of any of these groups ineligible
• Blood/body fluid analyses and other exams within 28 days prior to registration