NCT00004747

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Assess the efficacy of monthly intravenous mucoid exopolysaccharide Pseudomonas aeruginosa immune globulin (MEP IGIV) given over 1 year in reducing the frequency of acute pulmonary exacerbation in patients with cystic fibrosis, mild to moderate pulmonary disease, and mucoid P. aeruginosa colonization. II. Assess the effect of MEP IGIV on FEV1, sputum density of mucoid P. aeruginosa, and the quality of life in these patients. III. Assess the safety of monthly MEP IGIV. IV. Assess population-based MEP IGIV pharmacokinetics during chronic therapy.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. Patients are randomly assigned to 1 of 3 groups: low-dose intravenous mucoid exopolysaccharide Pseudomonas aeruginosa immune globulin (MEP IVIG), high-dose MEP IVIG, or placebo. Therapy is administered every 28 days for 12 months. Treatment is not initiated in the presence of an acute asthmatic attack. Concurrent chronic suppressive antibiotics are permitted.

Conditions

• Cystic Fibrosis
• Bacterial Infections

Interventions

Type	Name	Description
DRUG	mucoid exopolysaccharide P. aeruginosa immune globulin IV

Timeline

• Start date: 1995-07-01
• First posted: 2000-02-25
• Last updated: 2005-06-24