Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis

PHASE2CompletedINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

March 21, 2016

Primary Completion Date

April 19, 2019

Study Completion Date

September 27, 2019

Conditions
Autoimmune Pulmonary Alveolar Proteinosis
Interventions
DRUG

Molgramostim

300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation

DRUG

Placebo

Placebo nebulizer solution for inhalation

DEVICE

PARI eFlow nebulizer system

PARI eFlow nebulizer system

Trial Locations (30)

2050

Royal Prince Alfred Hospital, Sydney

23538

Universitätsklinikum Schleswig-Holstein Zentralklinikum, Lübeck Medizinische Klinik III, Pneumologie, Lübeck

32610

University of Florida, Gainesville

34020

Yedikule Pulmonary Diseases and Pulmonary Surgery Training and Research Hospital, Istanbul

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

82131

Asklepios Fachkliniken München - Gauting, Gauting

90095

UCLA, Los Angeles

Unknown

Aarhus University Hospital, Aarhus

CHU Rennes Hospital Pontchaillou, Rennes

Westdeutsches Lungenzentrum am Universitätsklinikum Essen, Essen

Thoraxklinik am Universitätsklinikum Heidelberg, Heidelberg

Attikon University Hospital, Athens

Rabin Medical Center, Petah Tikva

IRCCS Policlinico San Matteo, Pavia

Niigata University Medical and Dental Hospital, Niigata

National Hospital Organization Kinki-Chuo, Osaka

Tohoku University Hospital, Sendai

Aichi Medical University Hospital, Toyohashi

Kanagawa Cardiovascular and Respiratory Center, Yokohama

St. Antonius Hospital, Nieuwegein

Hospital de dia de Pneumologia, Lisbon

City Hospital St. Petersburg, Saint Petersburg

Centre Hospitalier Universitaire Vaudois, Lausanne

Royal Brompton Hospital, London

4200-319

Hospital Sao Joao, Porto

05984

II. Pulmonary Department National Institut for TB, Lung Diseases and Chest Surgery, Vyšné Hágy

0 3080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Division of Pulmonary and Critical Care Medicine, Seoul

135-710

Samsung Medical Center, Division of Pulmonary and Critical Care Medicine, Seoul

08907

Hospital University de Bellvitge (HUB), Barcelona

All Listed Sponsors
lead

Savara Inc.

INDUSTRY

NCT02702180 - Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis | Biotech Hunter | Biotech Hunter