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Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection

NCT03421743 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-07-03

Study results available
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Summary

The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human granulocyte-macrophage colony stimulating factor; rhGM-CSF) in subjects with persistent pulmonary non-tuberculous mycobacterial (NTM) infection. Participants will be treated for 24-weeks with inhaled molgramostim and followed up for 12-weeks after end of treatment. The primary aim of the trial is to investigate the efficacy of inhaled molgramostim on NTM sputum culture conversion to negative.

Conditions

  • Mycobacterium Infections, Nontuberculous

Interventions

DRUG

Inhaled molgramostim

300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation

DRUG

Antimycobacterial regimen

Multidrug NTM guideline-based antimycobacterial regimen

Sponsors & Collaborators

Principal Investigators

  • Grant Waterer, Prof. · Royal Perth Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-10-15
Completion
2020-01-13

Countries

  • Australia
  • United Kingdom

Study Locations

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Entities

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 NCT03421743 on ClinicalTrials.gov