Doxycycline Effects on Inflammation in Cystic Fibrosis

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Doxycycline is known to exhibit immune modulatory activities beyond its antibacterial effects. In particular, doxycycline is a potent inhibitor of matrix metalloproteinase 9, which is a protease derived largely from neutrophils. Recent studies demonstrate a significant correlation between pulmonary disease severity and sputum concentrations of MMP-9 in patients with CF. In addition, sputum MMP-9 levels are associated with airway remodeling in CF.

The goal of this study is to determine the therapeutic potential of doxycycline in modulating host airway inflammation in patients with CF. Specifically, the study will characterize the PK /PD of doxycycline, evaluate the safety of short term therapy, and explore the concentration effect relationship between doxycycline exposure and sputum biomarker levels.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Treatments: Doxycycline

Criteria

Inclusion Criteria:

• Age greater than 18 years

• Clinically stable (FEV1 within 10% of baseline)

• FEV1 > 40% predicted

Exclusion Criteria:

• Use of clinically significant concomitant drug therapy such as long-term use of nonsteroidal anti-inflammatory drugs or corticosteroids

• Known hypersensitivity to doxycycline

• Pregnancy or attempting to conceive, breast feeding, initiation of or change in hormonal method of contraception within 4 weeks of baseline or during the study

• Use of systemic antibiotics (except oral azithromycin) within 4 weeks of baseline

• Use of doxycycline within 60 days of baseline

• Known history of gastrointestinal bleeding or gastrointestinal ulceration.