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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

doxycycline

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

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

100 mg twice a day for 8 days

Interventions

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Doxycycline

100 mg twice a day for 8 days

Intervention Type DRUG

placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No