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Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection

NCT03597347 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-01-10

Study results available
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Summary

A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis (CF) subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy.

Conditions

  • Mycobacterium Infections, Nontuberculous
  • Cystic Fibrosis (CF)

Interventions

DRUG

Molgramostim nebulizer solution

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

DEVICE

PARI eFlow nebulizer system

PARI eFlow nebulizer system

Sponsors & Collaborators

Principal Investigators

  • Jerry Nick, MD · National Jewish Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2020-10-02
Completion
2020-10-02
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

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 NCT03597347 on ClinicalTrials.gov