N/A
Completed N=40
Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients
Source: ClinicalTrials.gov NCT01112059 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Number of Adverse Events — 5; 5 adverse events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
5; 5 | — |
| PRIMARY Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum |
4034; 8837 | <0.05 sig |
| SECONDARY Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment |
12683; 3224 | — |
| SECONDARY Mean Change in Pulmonary Function Over Treatment Duration |
6.9; 10.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01112059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.