Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase:
2
Recruitment Status:
Trial Completed
Study Drug(s):
Simvastatin
Number of Participants Being Recruited:
40
Single / Multi-Center:
Multi-Center
STUDY BACKGROUND INFORMATION:
This study examined the safety and efficacy of simvastatin in decreasing inflammation of the respiratory airways in patients with CF. Increased production of mucus in patients with CF contributes to the increase of bacteria that lead to lung infection and inflammation. Chronic infection leads to inflammation of the airways and eventually lung damage. Scientists believe that this condition could be improved by increasing the production of a gas commonly found in the lungs, called nitric oxide. This gas, which has anti-bacterial and anti-inflammatory properties, is found in lesser quantities in patients with CF. In this study researchers will use a drug called simvastatin to determine if it can help in increasing production of nitric oxide. Simvastatin is already used by millions of people to lower their cholesterol, is very safe, has few side-effects and is approved for use in some children.
ELIGIBILITY
Age:
>= 10 Years
FEV1:
>= 60 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.
Thirty-five subjects were enrolled in this open-label study that was conducted to evaluate the anti-inflammatory effect of simvastatin. Twenty-eight subjects completed the full 28 days of once daily dosing. For the primary outcome (exhaled nitric oxide) there was a non-significant increase (+1.2ppb).
Secondary Efficacy:
Simvastatin resulted in a statistically significant 8% decrease in sputum polymorphonuclear leukocytes in induced sputum suggesting an anti-inflammatory effect.
Safety:
Treatment was well-tolerated with only mild, transient, elevations in liver and muscle enzymes.
The summary of data provided here is from an abstract presented at the Cystic Fibrosis Foundation North American CF Conference (2008). These data may be preliminary and have not been peer-reviewed.
