Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004747
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase II Randomized Double-Blind Placebo-Controlled Study of Intravenous Mucoid Exopolysaccharide Pseudomonas Aeruginosa Immune Globulin for Cystic Fibrosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VU-7511 | None | None | None |