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Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients (DOXY)

This study is currently recruiting participants.
Verified May 2012 by University of Alabama at Birmingham
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Amit Gaggar, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01112059
First received: April 20, 2010
Last updated: May 11, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to examine the role of a well-known and well-tolerated antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized. This antibiotic does not effectively treat the bacteria in airways of cystic fibrosis patients, but may reduce the activity of inflammatory molecules in the disease.


Condition Intervention
Cystic Fibrosis
 Drug: Doxycycline
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Implication of Cross-Protease Dysregulation in Cystic Fibrosis: A Randomized, Placebo Controlled Pilot Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations (Implications of Cross-Protease Dysregulation in Cystic Fibrosis)

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)

  • Sputum and serum doxycycline pharmacokinetics [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Measurement of doxycycline levels at beginning and end of study in both sputum and serum

  • MMP-9 activity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Measurements of serum and sptum MMP-9 activity (basal and inducible)


Secondary Outcome Measures:
  • Colony forming units (CFU) of P. aeruginosa [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    CFU of sputum P. aeruginosa at beginning and end of study

  • Sputum inflammatory markers [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Will measure IL-8, HNE activity, neutrophil counts, proline-glycine-proline (PGP) levels, and prolyl endopeptidase activity

  • Change in pulmonary function [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Observe change in FEV1, FVC and FEF25-75 from beginning to end of study


Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: placebo
placebo
Active Comparator: doxycycline Drug: Doxycycline
100 mg twice a day for 10 days

Detailed Description:

One molecule that is inhibited by doxycycline is matrix metalloprotease-9, which is emerging as an important mediator of lung inflammation and damage in cystic fibrosis. We hypothesize that the addition of treatment with doxycycline in CF inpatients will reduce MMP-9 activity and inflammatory markers in the sputum of cystic fibrosis patients compared to CF patients not treated with doxycycline.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cystic Fibrosis
  • Hospitalization for Pulmonary exacerbation

Exclusion Criteria:

  • Significant GI illness
  • Participation in another Investigational Protocol
  • Allergies to Doxycycline
  • Sputum Culture only positive for Staphylococcus aureus,
  • Pregnant or Nursing
  • Unwilling to use effective birth control
  • Elevated LFT's greater than 3x the upper limit of normal
  • Creatinine greater than 1.5x the upper limit of normal
  • Lung transplantation
  • Substance abuse within 30 days of screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112059

Contacts
Contact: Gina M Sabbatini, BS 205-939-9410 gsabbatini@peds.uab.edu
Contact: Heather Y Hathorne, MAE, RRT. CCRC 205-939-9568 hhathorne@peds.uab.edu

Locations
United States, Alabama
University of alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Gina M Sabbatini, BS     205-939-9410     gsabbatini@peds.uab.edu    
Principal Investigator: Amit Gaggar, MD            
Sponsors and Collaborators
University of Alabama at Birmingham
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Amit Gaggar, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Amit Gaggar, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01112059     History of Changes
Other Study ID Numbers: F081024004
Study First Received: April 20, 2010
Last Updated: May 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
cystic fibrosis

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
 Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 22, 2013