Hydroxychloroquine for the Treatment of CF Lung Disease
Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Number of Participants Being Recruited:
Single / Multi-Center:
STUDY BACKGROUND INFORMATION:
Cystic Fibrosis (CF) remains a fatal disease.Â Improvements in therapies have slowed the rate of decline and many of these therapies are aimed at decreasing inflammation.Â Unfortunately anti inflammatory therapies including steroids and ibuprofen have side effects which limit their use.Â Laboratory studies have shown that chloroquine can improved CF cell function, including decreasing the binding of pseudomonas.Â Â It is known whether chloroquine would have a similar action in vivo.Â In clinical medicine, chloroquine has been replaced primarily by hydroxychloroquine.Â Â The most common use for hydroxychloroquine is for the treatment of malaria, but it is also used in chronic inflammatory disease such as arthritis and lupus.Â Â Hydroxcychloroqine has also been used chronic pulmonary diseases but it has never been examined in CF.Â Â This pilot study sought to determine whether there was any evidence that hydroxychloroquine has an anti inflammatory effect in CF.Â Inflammatory markers were measured in sputum collectedÂ from 20 CF patients before and after 4 weeks of hydroxychloroquine.
16 Years - 65 Years
>= 40 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:
Perkett, Elizabeth (615) 343-7617 firstname.lastname@example.org
Twenty patients received 4 weeks of once daily treatment with hydroxychloroquine. Seventeen patients completed the study. There were no statistically significant differences in lung function, weight in markers of inflammation in induced sputum (cell counts or cytokines).
Two patients discontinued the study due to adverse events (one with GI symptoms and the other due to pulmonary exacerbation). There were no statistically significant differences in safety labs and the drug appeared to be well-tolerated.
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.