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Anti-Inflammatory Completed with Results

PharmaNAC Phase 2b: N-Acetylcysteine Effects in CF (NAC 40630)

This study looked at the safety and effectiveness of an investigational product called N-acetylcysteine (NAC) on the basic processes that cause inflammation in CF lung disease. Study participants were randomized to receive N-acetylcysteine or placebo orally three times a day for 24 weeks. In addition to evaluating clinical outcomes, blood and sputum were collected to evaluate changes in inflammatory mediators.

 

Eligibility

  • Age:

    7 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 85%

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

Study Results

  • What We Learned:

    Study results show that there was no improvement in sputum neutrophil activity (a marker of airway inflammation) in the treatment group compared to the placebo group. Additionally, there were no safety concerns associated with N-acetylcysteine treatment.

  • Primary Findings:

    Effectiveness:

    This multi-center study was conducted between November 2008 and April 2011. A total of 70 CF patients were randomized. Of the 36 participants who received N-acetylcysteine, 30 completed the study, and of the 34 participants who received placebo, 32 completed the study. No effect was seen in the primary endpoint, change in sputum human neutrophil elastase (HNE) activity from Day 0 to Day 168 (Week 24).

     

    The N-acetylcysteine group maintained baseline FEV1 and FEF 25–75% throughout the 24-week period while 4–6% declines in these measures occurred in the placebo group; however, no statistically significant benefit was observed for incidence of pulmonary exacerbations or on patient-reported outcomes.

    Safety:

    There was no evidence that long-term treatment with N-acetylcysteine was associated with the development of pulmonary arterial hypertension (PH) in patients with CF as assessed by biomarker and clinical measurements.

  • Citation:

    J Cyst Fibros ;DOI 10.1016/j.jcf.2014.08.008

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:

    24 weeks

  • Number of Study Visits:

    3

Additional Information

Eligibility

  • Age:

    7 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 85%

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

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