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Mucociliary Clearance Completed with Results

Phase 1b study of inhaled AZD5634 in adults with CF (AstraZeneca D6600C00002)

This study evaluated the safety and tolerability of the inhaled drug AZD5634 in people with CF. It also evaluated the effect of AZD5634 on improving the ability to clear mucus from the lungs (lung mucociliary clearance - MCC).

 This study was a crossover study, meaning that all participants received AZD5634 and the placebo during the study. Participants were randomized to receive either one dose of inhaled AZD5634 (612µ) or placebo for the first part. In the second part, participants received the opposite of what they were given in the first part.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years to 60 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

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

Other Primary Eligibility Criteria

Patients currently being treated with ivacaftor monotherapy at Screening or received ivacaftor monotherapy within 30 days before Screening are excluded. Note: Patients receiving ivacaftor/lumicaftor combination thereapy may continue therapy during the study.

Study Results

  • What We Learned:

    This study found that a single dose of inhaled AZD5634 did not have a significant impact on mucociliary clearance when compared with placebo. AZD5634 did result in epithelial sodium channel (ENaC) inhibition in all participants, demonstrated by nasal potential difference (NPD).   Overall, AZD5634 was well tolerated.

  • Primary Findings:

    Effectiveness:

    This study was conducted between May 2017 and June 2018. Nine participants completed the trial.

     

    The primary efficacy objective was the average lung mucociliary clearance that occurred over a 1-hour period after receiving AZD5634. This study did not meet its primary objective as there was no significant difference in mucociliary clearance between AZD5634 and placebo (22 ± 10% vs 17 ± 9%, respectively).

     

    All participants demonstrated epithelial sodium channel (ENaC) inhibition by AZD5634 in the nasal potential difference (NPD) test in the nose.

    Safety:

    Overall, AZD5634 was well tolerated with no sign of elevated potassium levels.

     

    These results have been provided from an NACFC abstract and have not been peer reviewed.

  • Citation:

    J Cyst Fibros 2022;21:684-690

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

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    4 months

  • Number of Study Visits:

    4

Additional Information

  • Phase: ?more info

    Phase One

  • Study Sponsor: ?more info

    AstraZeneca

  • Study Drugs:

    AZD5634

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years to 60 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

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

Other Primary Eligibility Criteria

Patients currently being treated with ivacaftor monotherapy at Screening or received ivacaftor monotherapy within 30 days before Screening are excluded. Note: Patients receiving ivacaftor/lumicaftor combination thereapy may continue therapy during the study.

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