Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 20170333 | Other Identifier | Human Subject Research Office at University of Miami |
Not provided
Not provided
Not provided
due to slow enrollment and approval of the Trikafta for CF patients
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| University of Kansas Medical Center | OTHER |
| Cystic Fibrosis Foundation |
Not provided
Not provided
Not provided
The purpose of the study is to examine if a specific drug called losartan (Cozaar ®), generally used to treat high blood pressure and to protect kidneys from damage in patients suffering from Diabetes Mellitus, will have any effect on the nasal inflammation in patients with cystic fibrosis (CF). The study will be performed at the Pulmonary Division at the University of Miami, Cincinnati Children's Medical Hospital Center, University of Kansas Medical Center and University of Alabama-Birmingham.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan group | Experimental | Participant will receive the Losartan intervention and will take 50 mg losartan orally once daily for week 1, followed by 50 mg orally twice daily on weeks 2-12 (unless weight adjustment needed). |
|
| Placebo group | Placebo Comparator | Participant will receive the placebo intervention, matching the Losartan intervention, once daily for week 1, followed by twice daily on weeks 2-12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | 25 mg or 50 mg (based on patient's weight) Losartan tablets taken by mouth daily in the morning for week 1 followed by twice daily (one in the morning and one in the evening) on Weeks 2-12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nasal Potential Difference (NPD) to Assess CFTR Activity | Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activity will be measured as the change in NPD in response to apical perfusion with 0 Cl-/isoproterenol. NPD will be measured at the nasal epithelium via a voltmeter. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NPD to Assess CaCC Activity | Potential difference of Calcium dependent Chloride Channels (CaCC) will be measured as the change in NPD on on Adenosine Triphosphate (ATP) stimulation. NPD will be measured at the nasal epithelium via a voltmeter. | Baseline, 12 weeks |
| Change in NPD to Assess BK Activity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthias Salathe, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of Miami, Miller School of Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Losartan Group | Participant will receive the Losartan intervention and will take 50 mg losartan orally once daily for week 1, followed by 50 mg orally twice daily on weeks 2-12 (unless weight adjustment needed). |
| FG001 | Placebo Group | Participant will receive the placebo intervention, matching the Losartan intervention, once daily for week 1, followed by twice daily on weeks 2-12. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Losartan Group | Participant will receive the Losartan intervention and will take 50 mg losartan orally once daily for week 1, followed by 50 mg orally twice daily on weeks 2-12 (unless weight adjustment needed). |
| BG001 | Placebo Group |
| 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 | Change in Nasal Potential Difference (NPD) to Assess CFTR Activity | Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activity will be measured as the change in NPD in response to apical perfusion with 0 Cl-/isoproterenol. NPD will be measured at the nasal epithelium via a voltmeter. | Posted | Mean | Standard Error | mV | Baseline, 12 weeks |
|
16 weeks
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 | Losartan Group | Participant will receive the Losartan intervention and will take 50 mg losartan orally once daily for week 1, followed by 50 mg orally twice daily on weeks 2-12 (unless weight adjustment needed). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nose bleed | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthias Salathe | Kansas University Medical Center | 913 588 6045 | msalathe@kumc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2019 | Sep 23, 2020 | Prot_SAP_000.pdf |
Not provided
Not provided
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 |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
|
| placebo | Drug | Placebo tablets, matching the Losartan intervention, taken by mouth daily in the morning for week 1 followed by twice daily (one in the morning and one in the evening) on Weeks 2-12. |
|
|
Big Potassium (BK) activity will be measured as the change in NPD on Adenosine Triphosphate (ATP) stimulation. NPD will be assessed from nasal epithelium samples and analyzed via a voltmeter. |
| Baseline, 12 weeks |
| Change in FEV1 | Forced Expiratory Volume in 1 second (FEV1) assessed in liters will be measured using spirometry. | Baseline, 12 weeks |
| Change in Sweat Chloride Concentration | Sweat chloride concentration will be analyzed from participant sweat samples analyzed in millimoles per liter (mmol/l) | Baseline, 12 weeks |
| Change in Quality of Life (QoL) Scores as Assessed by the CFQ-R | Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a quality of life questionnaire with a total score ranging from 0-100 with a higher score indicating increased quality of life. | Baseline, 12 weeks |
| Change in Cytokine Levels | Nasal airway epithelial cells taken by brush will be assessed for cytokine levels including Interleukin IL-1beta, Transforming Growth Factor (TGF-beta) active and total, IL-6, IL-8 and IL-13 in pg/mL. | Baseline, 12 weeks |
| Change in hsCRP | Serum samples will be analyzed for High sensitivity C-Reactive Protein (hsCRP) values in mg/L. | Baseline, 12 weeks |
| Change in Blood Count Values | Serum blood count values including white blood count (WBC) and Absolute Neutrophil Counts (ANC) will be evaluated in units/uL. | Baseline, 12 weeks |
| Change in %PMN Values | Serum samples will be analyzed for % Polymorphonuclear (PMN) cells. | Baseline, 12 weeks |
| Change in SAA Values | Serum samples will be analyzed for Serum Amyloid A (SAA) values in mg/L. | Baseline, 12 weeks |
| Change in Calprotectin Values | Serum samples will be analyzed for calprotectin values in ug/mg. | Baseline, 12 weeks |
| Change in GM-CSF Values | Serum samples will be analyzed for % Granulocyte/Macrophage Colony Stimulating Factor (GM-CSF) values in pg/mL. | Baseline, 12 weeks |
| Change in TGF-beta Values | Serum samples will be analyzed for TGF-beta values in ng/mL. | Baseline, 12 weeks |
| Change in mRNA Expression | Change in messenger ribonucleic acid (mRNA) expression from nasal cells evaluated via quantitative polymerase chain reaction (qPCR) for Leucine Rich Repeating Protein 26 (LRRC26) and TGF-Beta). | Baseline, 12 weeks |
| Change in Losartan Metabolites Levels | Change in serum blood levels of Losartan and Losartan metabolites EXP3179 & EXP3174. | Baseline, 12 weeks |
| Miami |
| Florida |
| 33136 |
| United States |
| University of Kansas | Kansas City | Kansas | 66160 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Physician Decision |
|
Participant will receive the placebo intervention, matching the Losartan intervention, once daily for week 1, followed by twice daily on weeks 2-12. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Change in NPD to Assess CaCC Activity | Potential difference of Calcium dependent Chloride Channels (CaCC) will be measured as the change in NPD on on Adenosine Triphosphate (ATP) stimulation. NPD will be measured at the nasal epithelium via a voltmeter. | Posted | Mean | Standard Error | mV | Baseline, 12 weeks |
|
|
|
| Secondary | Change in NPD to Assess BK Activity | Big Potassium (BK) activity will be measured as the change in NPD on Adenosine Triphosphate (ATP) stimulation. NPD will be assessed from nasal epithelium samples and analyzed via a voltmeter. | Posted | Mean | Standard Error | mV | Baseline, 12 weeks |
|
|
|
| Secondary | Change in FEV1 | Forced Expiratory Volume in 1 second (FEV1) assessed in liters will be measured using spirometry. | Posted | Mean | Standard Error | Liter | Baseline, 12 weeks |
|
|
|
| Secondary | Change in Sweat Chloride Concentration | Sweat chloride concentration will be analyzed from participant sweat samples analyzed in millimoles per liter (mmol/l) | Posted | Mean | Standard Error | mmol/l | Baseline, 12 weeks |
|
|
|
| Secondary | Change in Quality of Life (QoL) Scores as Assessed by the CFQ-R | Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a quality of life questionnaire with a total score ranging from 0-100 with a higher score indicating increased quality of life. | Values were not measured for this outcome for all participants. | Posted | Baseline, 12 weeks |
|
|
| Secondary | Change in Cytokine Levels | Nasal airway epithelial cells taken by brush will be assessed for cytokine levels including Interleukin IL-1beta, Transforming Growth Factor (TGF-beta) active and total, IL-6, IL-8 and IL-13 in pg/mL. | Values were not measured for this outcome for all participants. | Posted | Baseline, 12 weeks |
|
|
| Secondary | Change in hsCRP | Serum samples will be analyzed for High sensitivity C-Reactive Protein (hsCRP) values in mg/L. | Values were not measured for this outcome for all participants. | Posted | Baseline, 12 weeks |
|
|
| Secondary | Change in Blood Count Values | Serum blood count values including white blood count (WBC) and Absolute Neutrophil Counts (ANC) will be evaluated in units/uL. | Values were not measured for this outcome for all participants. | Posted | Baseline, 12 weeks |
|
|
| Secondary | Change in %PMN Values | Serum samples will be analyzed for % Polymorphonuclear (PMN) cells. | Values were not measured for this outcome for all participants. | Posted | Baseline, 12 weeks |
|
|
| Secondary | Change in SAA Values | Serum samples will be analyzed for Serum Amyloid A (SAA) values in mg/L. | Values were not measured for this outcome for all participants. | Posted | Baseline, 12 weeks |
|
|
| Secondary | Change in Calprotectin Values | Serum samples will be analyzed for calprotectin values in ug/mg. | Values were not measured for this outcome for all participants. | Posted | Baseline, 12 weeks |
|
|
| Secondary | Change in GM-CSF Values | Serum samples will be analyzed for % Granulocyte/Macrophage Colony Stimulating Factor (GM-CSF) values in pg/mL. | Values were not measured for this outcome for all participants. | Posted | Baseline, 12 weeks |
|
|
| Secondary | Change in TGF-beta Values | Serum samples will be analyzed for TGF-beta values in ng/mL. | Values were not measured for this outcome for all participants. | Posted | Baseline, 12 weeks |
|
|
| Secondary | Change in mRNA Expression | Change in messenger ribonucleic acid (mRNA) expression from nasal cells evaluated via quantitative polymerase chain reaction (qPCR) for Leucine Rich Repeating Protein 26 (LRRC26) and TGF-Beta). | Values were not measured for this outcome for all participants. | Posted | Baseline, 12 weeks |
|
|
| Secondary | Change in Losartan Metabolites Levels | Change in serum blood levels of Losartan and Losartan metabolites EXP3179 & EXP3174. | Values were not measured for this outcome for all participants. | Posted | Baseline, 12 weeks |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Placebo Group | Participant will receive the placebo intervention, matching the Losartan intervention, once daily for week 1, followed by twice daily on weeks 2-12. | 0 | 5 | 0 | 5 | 5 | 5 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sore throat | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Pulmonary exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |