Denufosol Inhalation Solution in People With Mild CF Lung Disease (TIGER 2)
Restore Airway Surface Liquid
Number of Participants Being Recruited:
Single / 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 will compare one dose strength of the drug, denufosol, to a placebo in patients with mild CF lung disease. Results of a previous trial have shown that patients receiving denufosol had significantly better lung function than those receiving a placebo. The drug is designed to enhance the lung's natural mucosal hydration and mucociliary clearance. The trial planned to enroll 450 CF volunteers 5 years and older.
>= 5 Years
75 - 110 Percent Predicted
P. aeruginosa status:
B. cepacia status:
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:
Mathews, Dave (919) 287-1202 DMathews@inspirepharm.com
This Phase 3 placebo-controlled multi-national trial in 466 CF patients, age 5 years and older (mean age 15.1 years) with mild lung function impairment evaluated 48 weeks of treatment with denufosol (60 mg inhaled three times daily) vs placebo. The trial did not achieve statistical significance for the primary endpoint: change from baseline in FEV1 at 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.
Study treatments were well tolerated. The most common AE was cough, which was similar in both treatment groups.