Whole lung lavage followed by inhaled Sargramostim in the treatment of autoimmune pulmonary alveolar proteinosis. - WLL/inhaled GM-CSF in autoimmune PAP

• Conditions: Autoimmune PAP; MedDRA version: 9.1Level: LLTClassification code 10037316Term: Pulmonary alveolar proteinosis

• Registration Number: EUCTR2008-007086-23-IT
• Lead Sponsor: OSPEDALE POLICLINICO S. MATTEO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

autoimmune PAP diagnosis; age >= 18 years; persistant or progressive respiratory failure (PaO2 < 60 mmHg) or latent respiratory failure (SatO2 < 90% or desaturation > 5% in Bruce`s test) or persistant pulmonary TC abnormalities (intensity score >=3) (reasidual disease treated group)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

non autoimmune PAP; contraindications to WLL; contraindication to GM-CSF; pregnancy; refusal to the use of contraceptive methods during the study period; contraindications to the use of inhaled medicines.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified