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

• ClinicalTrials.gov Identifier: NCT01112059
• Recruitment Status: Completed
• First Posted: April 28, 2010
• Results First Posted: March 6, 2017
• Last Update Posted: March 6, 2017
• Sponsor: University of Alabama at Birmingham
• Collaborator: Cystic Fibrosis Foundation
• Information provided by (Responsible Party): Amit Gaggar, University of Alabama at Birmingham

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.

Condition or disease	Intervention/treatment	Phase
Cystic Fibrosis	Drug: Doxycycline; Other: placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations
• Study Start Date: November 2008
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: November 2012

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Patients given placebo twice a day for 8 days at beginning of inpatient CF exacerbation	Other: placebo; placebo
Active Comparator: doxycycline; Patients given doxycycline 100 mg tablet twice a day for 8 days at the beginning of inpatient CF exacerbation	Drug: Doxycycline; 100 mg twice a day for 8 days

Outcome Measures

Primary Outcome Measures :

1. Number of Adverse Events [ Time Frame: 1 month from enrollment ]
   Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)
2. Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum [ Time Frame: 8 days past baseline ]
   Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy

Secondary Outcome Measures :

1. Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment [ Time Frame: 8 days ]
   Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum
2. Mean Change in Pulmonary Function Over Treatment Duration [ Time Frame: Baseline to end of inpatient clinical exacerbation (average 14 days) ]
   Observe change in FEV1% predicted from beginning to end of study

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

University of alabama at Birmingham

Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

University of Alabama at Birmingham

Cystic Fibrosis Foundation

Investigators

• Principal Investigator: Amit Gaggar, MD; University of Alabama at Birmingham

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). pii: 1601102. doi: 10.1183/13993003.01102-2016. Print 2017 Apr.

• Responsible Party: Amit Gaggar, Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT01112059
• Other Study ID Numbers: F081024004
• First Posted: April 28, 2010
• Results First Posted: March 6, 2017
• Last Update Posted: March 6, 2017
• Last Verified: January 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Amit Gaggar, University of Alabama at Birmingham:

cystic fibrosis

Additional relevant MeSH terms:

Cystic Fibrosis; Fibrosis; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Doxycycline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents