Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients given placebo twice a day for 8 days at beginning of inpatient CF exacerbation |
|
| doxycycline | Active Comparator | Patients given doxycycline 100 mg tablet twice a day for 8 days at the beginning of inpatient CF exacerbation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | 100 mg twice a day for 8 days |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment | Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum | 8 days |
| Mean Change in Pulmonary Function Over Treatment Duration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amit Gaggar, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28381428 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo: placebo |
| FG001 | Doxycycline | Doxycycline: 100 mg twice a day for 8 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo: placebo |
| BG001 | Doxycycline | Doxycycline: 100 mg twice a day for 8 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events | Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs) | Posted | Number | adverse events | 1 month from enrollment |
|
|
13 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo: placebo |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney stone | Renal and urinary disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amit Gaggar, MD | UAB | 934-5400 | agaggar@uab.edu |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
placebo |
|
Observe change in FEV1% predicted from beginning to end of study
| Baseline to end of inpatient clinical exacerbation (average 14 days) |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum | Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy | Posted | Mean | Standard Deviation | ng/mg total protein | 8 days past baseline |
|
|
|
|
| Secondary | Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment | Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum | Posted | Mean | Standard Deviation | ng/mg total protein | 8 days |
|
|
|
| Secondary | Mean Change in Pulmonary Function Over Treatment Duration | Observe change in FEV1% predicted from beginning to end of study | Posted | Mean | Standard Deviation | Percentage of predicted FEV1 | Baseline to end of inpatient clinical exacerbation (average 14 days) |
|
|
|
| 0 |
| 19 |
| 5 |
| 19 |
| EG001 | Doxycycline | Doxycycline: 100 mg twice a day for 8 days | 0 | 20 | 5 | 20 |
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Increased cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| tingling of lips | General disorders | Non-systematic Assessment | Self-limited tingling of lips |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Pelvic pain | Renal and urinary disorders | Non-systematic Assessment | Transient pelvic pain |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |