Doxycycline Effects on Inflammation in Cystic Fibrosis

NCT01323101 | Completed Phase 4 DMC

• 1 other identifier: HS-08-00017
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• To determine the effect of doxycycline on inflammatory biomarkers

  Within 42 days

Secondary Outcomes (1)

• To characterize the pharmacokinetics, pharmacodynamics and safety of doxycycline in patients with cystic fibrosis

  Within 42 days

Study Arms (2)

Control

SHAM COMPARATOR

No doxycycline

Other: No doxycycline

Doxycycline

EXPERIMENTAL

Drug: Doxycycline

Interventions

Doxycycline DRUG

Doxycycline 40mg, 100mg, 200mg tablet once daily, or no drug for 28 days.

Also known as: Doryx, Vibramycin

Doxycycline

No doxycycline OTHER

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years
• Clinically stable (FEV1 within 10% of baseline)
• FEV1 \> 40% predicted

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

Related Publications (1)

• Beringer PM, Owens H, Nguyen A, Benitez D, Rao A, D'Argenio DZ. Pharmacokinetics of doxycycline in adults with cystic fibrosis. Antimicrob Agents Chemother. 2012 Jan;56(1):70-4. doi: 10.1128/AAC.05710-11. Epub 2011 Oct 24.

  PMID: 22024822 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Paul M Beringer, Pharm.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: March 25, 2011
• Study Start: April 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)