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Doxycycline Effects on Inflammation in Cystic Fibrosis

This study has been completed.
Information provided by (Responsible Party):
Paul Beringer, University of Southern California Identifier:
First received: February 15, 2011
Last updated: March 28, 2017
Last verified: March 2017

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.

Condition Intervention Phase
Cystic Fibrosis
Drug: Doxycycline
Other: No doxycycline
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Effect of Doxycycline on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Patients With Cystic Fibrosis.

Resource links provided by NLM:

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • To determine the effect of doxycycline on inflammatory biomarkers [ Time Frame: Within 42 days ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics, pharmacodynamics and safety of doxycycline in patients with cystic fibrosis [ Time Frame: Within 42 days ]

Enrollment: 21
Study Start Date: April 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control
No doxycycline
Other: No doxycycline
Experimental: Doxycycline Drug: Doxycycline
Doxycycline 40mg, 100mg, 200mg tablet once daily, or no drug for 28 days.
Other Names:
  • Doryx
  • Vibramycin

Detailed Description:

This study will consist of a prospective, open-label, randomized, controlled trial conducted in 24 patients with cystic fibrosis. Twenty subjects will be stratified in a 1:2 ratio based on baseline FEV1 into mild (> 70%) or moderate (40-70%) pulmonary disease in order to control for disease severity within each dose level. The subjects will be randomized in blocks of four to receive no drug, 40mg, 100mg, or 200mg daily for 28 days.

Sputum samples will be obtained in all groups by induction with hypertonic saline at baseline, 8, 24, and 48 hours following the first dose and then weekly for 4 weeks. Sputum will also be collected at two follow up visits after the treatment period at weeks 5 and 6.

In the doxycycline group, serial blood samples (5 mL) for determination of doxycycline concentrations will be obtained before and at 0, 0.5, 1, 2, 4, 12, 24, and 48 hours following the 1-hr infusion of a single IV dose. Once daily dosing of doxycycline will resume immediately following the 48-hour blood sample and will continue until day 28. Additional levels will be obtained pre-dose, and 1, 2, and 3 hours after doses administered on days 14 and 28. A sample of blood will be obtained at baseline, and at days 28 for inflammatory marker analyses.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01323101

United States, California
University of Southern California
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
Principal Investigator: Paul M Beringer, Pharm.D. University of Southern California
  More Information

Responsible Party: Paul Beringer, Associate Professor, University of Southern California Identifier: NCT01323101     History of Changes
Other Study ID Numbers: HS-08-00017
Study First Received: February 15, 2011
Last Updated: March 28, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on April 21, 2017