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Completed

NCT Number: NCT01112059

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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxycycline

Drug

100 mg twice a day for 8 days

Placebo

Other

placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

A Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations

Acronym: DOXY

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 28, 2010
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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