Cystic FibrosisDOXYNCT01112059
Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients
A study testing Doxycycline in people with Cystic Fibrosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cystic Fibrosis
- Hospitalization for Pulmonary exacerbation
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: A Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Doxycycline, placebo
- Keywords
- cystic fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
100 mg twice a day for 8 days
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients given placebo twice a day for 8 days at beginning of inpatient CF exacerbation Receives: Other: placebo |
| doxycycline | Active comparator | Patients given doxycycline 100 mg tablet twice a day for 8 days at the beginning of inpatient CF exacerbation Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)
Measured: 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
Measured: 8 days past baseline
Secondary outcomes (2)
Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment
Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum
Measured: 8 days
Mean Change in Pulmonary Function Over Treatment Duration
Observe change in FEV1% predicted from beginning to end of study
Measured: Baseline to end of inpatient clinical exacerbation (average 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startNov 2008
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Amit Gaggar, University of Alabama at Birmingham
- Investigators
- Amit Gaggar, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112059
- Sponsor's protocol ID
- F081024004
- Acronym
- DOXY
- Status last verified
- Jan 2017
- First submitted
- 20 Apr 2010
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28381428
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations
- ClinicalTrials.gov ID
- NCT01112059
- Acronym / sponsor ID
- DOXY / F081024004
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Nov 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Posted 6 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: placeboPatients given placebo twice a day for 8 days at beginning of inpatient CF exacerbation |
| doxycycline | Active comparator | Drug: DoxycyclinePatients given doxycycline 100 mg tablet twice a day for 8 days at the beginning of inpatient CF exacerbation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cystic Fibrosis
- Hospitalization for Pulmonary exacerbation
Key exclusion criteria (10 listed)
- Significant GI illness
- Participation in another Investigational Protocol
- Allergies to Doxycycline
- Sputum Culture only positive for Staphylococcus aureus,
- Pregnant or Nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline100 mg twice a day for 8 days | Drug | doxycycline |
| placeboplacebo | Other | Placebo |
Primary outcome
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)
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
2 secondary outcomes
Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment
Time frame: 8 days
Mean Change in Pulmonary Function Over Treatment Duration
Time frame: Baseline to end of inpatient clinical exacerbation (average 14 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28381428Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Gaggar, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline in people with Cystic Fibrosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 1 month from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.