CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 139 enrolled
Drug / intervention
Molgramostim +2 moredrug
Likely dose
Molgramostim 300 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02702180
NCT02702180Phase 2Completed

A Randomised, Double-blind, Placebo-controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis Patients

Savara Inc.·interventional·Posted Mar 8, 2016·Updated Apr 12, 2023

In Brief

A Phase 2 clinical trial evaluating Molgramostim, Placebo, and 1 other intervention for Autoimmune Pulmonary Alveolar Proteinosis. Completed, enrolled 139 participants across 30 sites in 18 countries.

Detailed Summary

This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor \[rhGM-CSF\]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients. A third of the patients will receive inhaled molgramostim once daily for 24 weeks, a third will receive inhaled molgramostim intermittently (7 days on, 7 days off) for 24 weeks and a third will receive inhaled matching placebo for 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Portugal, Russia, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 8, 2016
Enrollment StartMar 21, 2016
Primary CompletionApr 19, 2019
Study CompletionSep 27, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.3 years ago

Interventions

Molgramostimdrug

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

Placebodrug

Placebo nebulizer solution for inhalation

PARI eFlow nebulizer systemdevice

PARI eFlow nebulizer system