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

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: placebo; Drug: Doxycycline

• Registration Number: NCT01112059
• Lead Sponsor: University of Alabama at Birmingham

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.

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Disposition First Submitted: 2013-12-19
• Disposition First Submitted QC: 2013-12-19
• Disposition First Posted: 2014-01-27
• Results First Submitted: 2016-11-04
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-11
• Last Update Submitted: 2017-01-11
• Results First Posted: 2017-03-06
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Patients given placebo twice a day for 8 days at beginning of inpatient CF exacerbation
doxycycline	Doxycycline	Patients given doxycycline 100 mg tablet twice a day for 8 days at the beginning of inpatient CF exacerbation

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	1 month from enrollment	Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)
Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum	8 days past baseline	Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy

Secondary Outcome Measures

Name	Time	Method
Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment	8 days	Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum
Mean Change in Pulmonary Function Over Treatment Duration	Baseline to end of inpatient clinical exacerbation (average 14 days)	Observe change in FEV1% predicted from beginning to end of study

Trial Locations

Locations (1)

University of alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States