NCT00043355

Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Safety and Efficacy of Inhaled Interferon Gamma-1b With Antimycobacterials in Previously Treated or Mod-to-Sev Pulmonary Mycobacterium Avium Complex Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: InterMune · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to test the safety and effectiveness of inhaled Interferon gamma-1b (IFN-g 1b), when administered for 48 weeks and in combination with oral antibiotics which may be administered for up to 72 weeks for the treatment of a lung infection caused by a bacterium called Mycobacterium avium complex . FDA has not approved Interferon gamma-1b for use in patients with MAC infection of the lungs, which is the purpose of this study.Interferon gamma-1b and similar proteins play important roles in establishing and maintaining protective immune responses against a variety of microorganisms.

Detailed description

Laboratory research has shown that a mouse form of interferon gamma is effective in treating mice with infections caused by bacteria similar to MAC as well as MAC infection.

Conditions

• Lung Infection

Interventions

Type	Name	Description
DRUG	interferon gamma-1b	500 mcg, oral, three times weekly

Timeline

• Start date: 2000-12-01
• Completion: 2003-02-01
• First posted: 2002-08-12
• Last updated: 2007-11-01