Clinical Trial: Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan

Brief Summary:

Objective: Determine the safety and efficacy of GM-CSF inhalation in patients with aPAP.

Study Design: multi-center, randomized, double-blind, placebo- controlled, safety/efficacy study.

Detailed Summary:
Sponsor: Niigata University Medical & Dental Hospital

Current Primary Outcome: Change value of AaDO2 between baseline and 24 weeks [ Time Frame: 24 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Niigata University Medical & Dental Hospital

Dates:
Date Received: July 13, 2016
Date Started: May 2016
Date Completion:
Last Updated: December 27, 2016
Last Verified: December 2016