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Mucociliary Clearance Completed with Results

Denufosol Inhalation Solution for People with CF and Mild Lung Disease (TIGER 1) (Inspire INS 08-108)

The purpose of this trial was to evaluate the safety and effectiveness of inhaled Denufosol, a drug designed to enhance the hydration and clearance of mucus in the lungs of CF patients.

Participants in this study were randomized to receive either inhaled denufosol or placebo given three times daily for 24 weeks. After 24 weeks all participants were given denufosol for another 24 weeks.In people with CF, mucus builds up and clogs the lungs making breathing very difficult. The thick mucus also causes bacteria to get stuck in the airways, causing inflammation and infections that lead to lung damage. Results of an earlier smaller phase 2 trial suggested that treatment with denufosol might improve lung function.

Eligibility

  • Age:

    5 Years to 999 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    75% or greater

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 a significant improvement in lung function in the treatment group compared to the placebo group. Additionally, there were no significant safety concerns associated with denufosol treatment.

  • Primary Findings:

    Effectiveness:

    This phase 3 placebo-controlled multi-national study was conducted between August 2006 and October 2008. A total of 352 people with CF (Age >= 5 years) with normal to mildly impaired lung function )FEV1 >75 % predicted) participated. Approximately 90% of participants in both treatment groups completed the 24 week randomized part of the study. The study met its primary endpoint: participants treated with denufosol had a statistically significant improvement in lung function after 24 weeks (absolute improvement in FEV1 of 0.048L compared with 0.003L for the placebo group).

     

    No significant differences between groups were observed for secondary endpoints including exacerbation rate and other measures of lung function.

    Safety:

    Denufosol was well tolerated and adverse event rates were similar to placebo.

  • Citation:

    Am J Respir Crit Care Med 2011;183(5):627-34

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:

    50 weeks

  • Number of Study Visits:

    10

Additional Information

  • Phase: ?more info

    Phase Three

  • Study Sponsor: ?more info

    Inspire

  • Study Drugs:

    Denufosol

Eligibility

  • Age:

    5 Years to 999 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    75% or greater

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

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