Clinical Trial: Prospective Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prospective Open-Label Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis

Brief Summary: The purpose of this study is to determine whether the use of rituximab is effective in treating pulmonary alveolar proteinosis by leading to an improvement in lung function and disease status.

Detailed Summary: The goal of this study is to conduct a prospective, open-label 6-month trial of rituximab in patients who present with symptomatic primary or idiopathic PAP. A total of 10 subjects with primary PAP will be enrolled over 12 months at East Carolina University. Patients over age 18 with a clinical diagnosis of moderate symptomatic idiopathic PAP, established by appropriate clinical history, radiographic and physiologic findings, presence of circulating anti-GM-CSF antibody, and confirmatory findings on bronchoscopy with bronchoalveolar lavage and/or open-lung biopsy will be recruited. Patients with newly diagnosed PAP or established disease may be considered for this study.
Sponsor: East Carolina University

Current Primary Outcome: Evaluate symptomatic, physiologic and radiographic effects of therapy [ Time Frame: 6-months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate the overall tolerability of therapy and the requirement for therapeutic whole-lung lavage [ Time Frame: 6-months ]

Original Secondary Outcome: Same as current

Information By: East Carolina University

Dates:
Date Received: October 31, 2007
Date Started: January 2007
Date Completion: December 2009
Last Updated: May 6, 2008
Last Verified: May 2008