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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doxycycline
placebo
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

doxycycline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Adverse Events
Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)
Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum
Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy

Secondary Outcome Measures

Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment
Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum
Mean Change in Pulmonary Function Over Treatment Duration
Observe change in FEV1% predicted from beginning to end of study

Full Information

First Posted
April 20, 2010
Last Updated
January 11, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
Cystic Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01112059
Brief Title
Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients
Acronym
DOXY
Official Title
A Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Cystic Fibrosis Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients given placebo twice a day for 8 days at beginning of inpatient CF exacerbation
Arm Title
doxycycline
Arm Type
Active Comparator
Arm Description
Patients given doxycycline 100 mg tablet twice a day for 8 days at the beginning of inpatient CF exacerbation
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
100 mg twice a day for 8 days
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Number of Adverse Events
Description
Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)
Time Frame
1 month from enrollment
Title
Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum
Description
Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy
Time Frame
8 days past baseline
Secondary Outcome Measure Information:
Title
Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment
Description
Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum
Time Frame
8 days
Title
Mean Change in Pulmonary Function Over Treatment Duration
Description
Observe change in FEV1% predicted from beginning to end of study
Time Frame
Baseline to end of inpatient clinical exacerbation (average 14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Gaggar, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28381428
Citation
Xu X, Abdalla T, Bratcher PE, Jackson PL, Sabbatini G, Wells JM, Lou XY, Quinn R, Blalock JE, Clancy JP, Gaggar A. Doxycycline improves clinical outcomes during cystic fibrosis exacerbations. Eur Respir J. 2017 Apr 5;49(4):1601102. doi: 10.1183/13993003.01102-2016. Print 2017 Apr.
Results Reference
derived

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

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