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Study Name: Denufosol in People with CF ages 2 - 4 years
Study Type: Interventional
Intervention Category: Restore Airway Surface Liquid
Study Sponsor: Inspire
Study Phase: 2
Recruitment Status: Trial Completed
Study Drug(s): Denufosol
Number of Participants Being Recruited: 24
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
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.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT01181622?term=inspire+and+cystic+fibrosis&rank=9
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Not applicable

Secondary Efficacy:

Not applicable

Safety:

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 These data may be preliminary and have not been peer-reviewed.

Citation:

Not Available
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