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Doxycycline Effects on Inflammation in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01323101
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Paul Beringer, University of Southern California

Brief 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Doxycycline Other: No doxycycline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Doxycycline on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Patients With Cystic Fibrosis.
Study Start Date : April 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01323101

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United States, California
University of Southern California
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
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Principal Investigator: Paul M Beringer, Pharm.D. University of Southern California
Publications of Results:
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Responsible Party: Paul Beringer, Associate Professor, University of Southern California Identifier: NCT01323101    
Other Study ID Numbers: HS-08-00017
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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