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

The University of Alabama at Birmingham

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Other: placebo; Drug: Doxycycline

Study type: Interventional

Funder types: Other

Identifiers

NCT01112059

F081024004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients given placebo twice a day for 8 days at beginning of inpatient CF exacerbation

Treatment:

Other: placebo

doxycycline

Active Comparator group

Description:

Patients given doxycycline 100 mg tablet twice a day for 8 days at the beginning of inpatient CF exacerbation

Treatment:

Drug: Doxycycline