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Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan

NCT02835742 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2019-02-07

No results posted yet for this study

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.

Conditions

  • Pulmonary Alveolar Proteinosis, Autoimmune

Interventions

DRUG

Sargramostim

DRUG

Placebo

Sponsors & Collaborators

  • Niigata University Medical & Dental Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2017-08-31
Completion
2018-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835742 on ClinicalTrials.gov