NCT01983657

Study of Subcutaneous Injection of Low-dose rhGM-CSF +/- WLL in PAP.

Study of Subcutaneous Injection of Low-dose Recombinant Granulocyte Macrophage-Colony Stimulating Factor (rhGM-CSF) +/- Whole Lung Lavage(WLL) in Pulmonary Alveolar Proteinosis.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 17 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish an efficient and economic treatment scheme by evaluation of the safety and efficacy of subcutaneous injection of low-dose rhGM-CSF, or of similar injection after whole lung lavage , in patients with PAP.

Detailed description

The purpose of this study is to establish an efficient and economic treatment scheme by evaluation of the safety and efficacy of subcutaneous injection of low-dose rhGM-CSF, or of similar injection after whole lung lavage , in patients with PAP. During the observation, study visits will occur at the end of each month. During the 1-year follow-up period which is lasting 6 months after the treatment, all participants will be required to check the various efficacy indicators.

Conditions

• Pulmonary Alveolar Proteinosis

Interventions

Type	Name	Description
DRUG	rhGM-CSF	GM-CSF will be given subcutaneously according to the rule in different groups.
PROCEDURE	Whole Lung Lavage(WLL)	using double lumen endotracheal tube (DLT) to selectively lavage one lung

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-06-01
• Completion: 2014-10-01
• First posted: 2013-11-14
• Last updated: 2013-11-18

Locations

1 site across 1 country: China