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Anti-Infective Completed with Results

Study to evaluate inhaled molgramostim in adults 18 years and older with cystic fibrosis and an NTM infection in the lungs (Savara SAV008-02)

This study evaluated the effectiveness of inhaled molgramostim (Molgradex), a drug intended to treat nontuberculous mycobacterial (NTM) infections in the lungs of people with CF.

 This study was open-label, meaning all participants received molgramostim. Participants received inhaled molgramostim (300 µg/dose) once daily for forty-eight (48) weeks using the PARI eFlow nebulizer system.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    30% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Participants must have a history of chronic pulmonary infection with M. avium complex (MAC) or M. abscessus complex (MABSC) with at least 3 positive samples within the previous 2 years.

Study Results

  • What We Learned:

    This study was stopped early due to the impact of COVID-19 on participant recruitment and retention, and the impact of the approval of elexacaftor/tezacaftor/ivacaftor (Trikafta®) mid-study (November 2019) on the primary study endpoint.  The decision to stop the study was not based on safety concerns.

  • Primary Findings:

    Effectiveness:

    This study was conducted between June 2019 and October 2020. The study enrolled 14 patients to receive open-label inhaled GM-CSF. The study was terminated early and no participants completed the study. The COVID-19 pandemic and other changes in the management of CF unrelated to NTM are cited as reasons for terminating this study early

     

     

    Safety:

    No deaths or unusually high rate of severe adverse events were reported in the small number of participants.

  • Citation:

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    72 weeks

  • Number of Study Visits:

    19

Additional Information

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    30% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Participants must have a history of chronic pulmonary infection with M. avium complex (MAC) or M. abscessus complex (MABSC) with at least 3 positive samples within the previous 2 years.

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