This phase 2 study will looked at the safety and tolerability of denufosol aerosolized three times a day in pediatric CF patients 2 to 4 years of age.
ELIGIBILITY
Age:
2 Years - 4 Years
FEV1:
Not Applicable
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.
This randomized study to evaluate the short term safety and tolerability of denufosol for inhalation enrolled 25 children, age 2 -4 years old. Subjects received with denufosol (60 mg, 3 times daily) or placebo for 7 to 10 days. Denufosol was well tolerated. No subjects met pre-defined intolerability criteria as evaluated at the 2 study visits. The most commonly reported adverse event was coughing.
The summary of data provided here is from an abstract presented at the Cystic Fibrosis Foundation North American CF Conference (2011). These data may be preliminary and have not been peer-reviewed.
