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

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ClinicalTrials.gov Identifier: NCT01112059
Recruitment Status : Completed
First Posted : April 28, 2010
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cystic Fibrosis Drug: Doxycycline Other: placebo

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations
Study Start Date : November 2008
Primary Completion Date : November 2012
Study Completion Date : November 2012

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients given placebo twice a day for 8 days at beginning of inpatient CF exacerbation
Other: placebo
Active Comparator: doxycycline
Patients given doxycycline 100 mg tablet twice a day for 8 days at the beginning of inpatient CF exacerbation
Drug: Doxycycline
100 mg twice a day for 8 days

Outcome Measures

Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 1 month from enrollment ]
    Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)

  2. Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum [ Time Frame: 8 days past baseline ]
    Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy

Secondary Outcome Measures :
  1. Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment [ Time Frame: 8 days ]
    Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum

  2. Mean Change in Pulmonary Function Over Treatment Duration [ Time Frame: Baseline to end of inpatient clinical exacerbation (average 14 days) ]
    Observe change in FEV1% predicted from beginning to end of study

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 ClinicalTrials.gov identifier (NCT number): NCT01112059

United States, Alabama
University of alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Cystic Fibrosis Foundation Therapeutics
Principal Investigator: Amit Gaggar, MD University of Alabama at Birmingham
More Information

Responsible Party: Amit Gaggar, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01112059     History of Changes
Other Study ID Numbers: F081024004
First Posted: April 28, 2010    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Amit Gaggar, University of Alabama at Birmingham:
cystic fibrosis

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