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

Cystic Fibrosis Clinical Trial

— DOXY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112059
• Other study ID #: F081024004
• Status: Completed
• Phase: N/A
• First received: April 20, 2010
• Last updated: January 11, 2017
• Start date: November 2008
• Est. completion date: November 2012

Study information

• Verified date: January 2017
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Doxycycline
100 mg twice a day for 8 days

Other:
• placebo
placebo

Locations

Country	Name	City	State
United States	University of alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Cystic Fibrosis Foundation Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events	Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)	1 month from enrollment
Primary	Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum	Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy	8 days past baseline
Secondary	Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment	Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum	8 days
Secondary	Mean Change in Pulmonary Function Over Treatment Duration	Observe change in FEV1% predicted from beginning to end of study	Baseline to end of inpatient clinical exacerbation (average 14 days)