Overview

Whole Lung Lavage (WLL)/Inhaled Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis (PAP)

Status:
Unknown status

Trial end date:
2013-07-01

Target enrollment:

Participant gender:

Summary

The investigators designed an experimental, randomized by parallel groups, stratified according to previous treatment, open-label study evaluating the superiority of the combination of whole lung lavage/inhaled GM-CSF versus whole lung lavage alone in patients with pulmonary alveolar proteinosis. The primary efficacy objective is the total resolution of the pulmonary involvement. PAP patients matching the enrolment criteria will enter the study. If requiring the first WLL, they will be randomized to receive WLL (1st level control group) or WLL/followed by inhaled GM-CSF, according to an acute (12 weeks) followed by maintenance (6 months) schedule (1st level treated group).

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

IRCCS Policlinico S. Matteo

Collaborator:

Agenzia Italiana del Farmaco

Treatments:

Molgramostim
Sargramostim