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Study Name: Denufosol Inhalation Solution for People with CF and Mild Lung Disease (TIGER 1)
Study Type: Interventional
Intervention Category: Restore Airway Surface Liquid
Study Sponsor: Inspire
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Denufosol
Number of Participants Being Recruited: 350
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this trial was to evaluate the safety and effectiveness of inhaled Denufosol designed to enhance the hydration and clearance of mucus in the lungs of CF patients. 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. The trial compared one dose strength of the drug, denufosol, to a placebo in patients with mild CF lung disease. The drug was designed to enhance the lung's natural mucosal hydration and mucociliary clearance.
ELIGIBILITY
Age: 5 Years - 999 Years
FEV1: >= 75 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Negative
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00357279?term=inspire+and+cystic+fibrosis&rank=4
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Three hundred fifty-two CF patients (Age >= 5 years) with normal to mildly impaired lung function were enrolled in this Phase 3 study that evaluated the efficacy and safety of denufosol. Patients received either 60 mg denufosol or placebo nebulized three times daily for 24 weeks followed by 24 week treatment with open-label denufosol. The primary endpoint was met for the study with mean changes in FEV1 from baseline to Week 24 significantly greater for denufosol (0.048 L) than for placebo (0.003L) (treatment effect, 0.045; P = 0.047).

Secondary Efficacy:

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 and growth profiles were similar to placebo.

Citation:

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

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