NCT01112059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 6, 2017

Completed
Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

4 years

First QC Date

April 20, 2010

Results QC Date

November 4, 2016

Last Update Submit

January 11, 2017

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis

Outcome Measures

Primary Outcomes (2)

  • Number of Adverse Events

    Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)

    1 month from enrollment

  • Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum

    Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy

    8 days past baseline

Secondary Outcomes (2)

  • Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment

    8 days

  • Mean Change in Pulmonary Function Over Treatment Duration

    Baseline to end of inpatient clinical exacerbation (average 14 days)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: placebo

doxycycline

ACTIVE COMPARATOR

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

Drug: Doxycycline

Interventions

DoxycyclineDRUG

100 mg twice a day for 8 days

doxycycline
placeboOTHER

placebo

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cystic Fibrosis
  • Hospitalization for Pulmonary exacerbation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

  • 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.

    PMID: 28381428DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Limitations and Caveats

Although the study has a relatively large number of subjects, this was a single center trial. In addition, it is possible that the protein readouts are mediated by modulating the dysregulated protease activity in the airway.

Results Point of Contact

Title
Amit Gaggar, MD
Organization
UAB
agaggar@uab.edu
934-5400

Study Officials

  • Amit Gaggar, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 28, 2010

Study Start

November 1, 2008

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

March 6, 2017

Results First Posted

March 6, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)