NCT00311883

Hydroxychloroquine in Cystic Fibrosis

Phase 1 Study of Hydroxychloroquine in Cystic Fibrosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis before and after a 4 week course of oral hydroxychloroquine.

Detailed description

Open label study of effect of hydroxychloroquine on inflammation, bacterial burden and exhaled breath condensate pH in patients with cystic fibrosis. Patients with cystic fibrosis, 16 years or older and with pulmonary function tests with an FEV1 greater than 40% predicted will be eligible for enrollment. Enrolled subjects will undergo collection of exhaled breath condensate and sputum induction and collection following nebulized hypertonic saline, before and following a 4 week course of oral hydroxychloroquine at 200 mg a day. Inflammatory mediators, neutrophil counts, and bacterial density in sputum and exhaled breath condensate pH will be measure at entry and at the end of 4 weeks of oral drug. There will be no placebo group.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	hydroxychloroquine

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-04-06
• Last updated: 2008-01-30

Locations

1 site across 1 country: United States