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

Date de début de l'étude : 1 juillet 1995

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