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Mucociliary Clearance Completed with Results
Denufosol Inhalation Solution in People With Mild CF Lung Disease (TIGER 2) (Inspire 08-110)
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 48 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
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Age:
5 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
75 to 110%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
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What We Learned:
Study results show that there was no significant change in lung function in the treatment group compared to the placebo group. Additionally, there were no significant safety concerns associated with denufosol treatment.
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Primary Findings:
Effectiveness:
This Phase 3 placebo-controlled multi-national study was conducted between February 2008 and October 2010. A total of 466 people with CF who were 5 years of age and older (mean age 15.1 years) and who had normal to mildly impaired lung function (FEV1 >75 % of predicted) participated. Of the 233 participants randomized to denufosol 190 completed the study. A similar number of participants randomized to placebo completed the study (193 of 233 randomized). There was no benefit of denufosol observed on the primary endpoint, change in lung function (change in FEV1 from baseline to week 48).
The three key secondary endpoints: rate of change in percent predicted FEV1 over 48 weeks, change from baseline in FEF 25%-75% at week 48, and time to first pulmonary exacerbation also did not show any statistically significant differences between treatment groups.
Safety:
Denufosol was well tolerated. The most common AE was cough, which was similar in both treatment groups.
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Citation:
J Cyst Fibros 2012;11(6):539-549
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
48 weeks -
Number of Study Visits:
6
Additional Information
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Phase: ?more info
Phase Three -
Study Sponsor: ?more info
Inspire -
Study Drugs:
Eligibility
-
Age:
5 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
75 to 110%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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