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

NCT02702180 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2023-04-12

Study results available
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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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Cliff Morgan, MD · Royal Brompton Hospital, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-21
Primary Completion
2019-04-19
Completion
2019-09-27
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Portugal
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02702180 on ClinicalTrials.gov