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| ID | Type | Description | Link |
|---|---|---|---|
| SCUSF-PILOT-0108 | Other Identifier | SunCoast CCOP Research Base | |
| 5U10CA081920 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Losartan may be effective in treating patients with idiopathic pulmonary fibrosis.
PURPOSE: This clinical trial is studying the side effects of losartan and to see how well it works in treating patients with idiopathic pulmonary fibrosis.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral losartan potassium daily for 1 year in the absence of disease progression or unacceptable toxicity.
Patients undergo pulmonary function tests with gas diffusion lung volumes, Carbon monoxide diffusing capacity (DLCO) tests, and 6-minute walk tests at baseline and then at 3, 6, 9, and 12 months. Patients also complete baseline/transition dyspnea index questionnaires at baseline and then at 1, 3, 6, 9, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan | Experimental | 50 mg tablets of losartan taken daily by mouth for 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| losartan | Drug | 50 mg losartan taken daily by mouth in capsule form for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year | Forced vital capacity (FVC) must be >= 50% at baseline. Stable FVC response is defined as a -5% change in FVC from baseline up to a +5% change from baseline. Improved FVC response is defined as 5% or greater increase in the predicted value of FVC on pulmonary function testing following 12 months of treatment. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year | 1 year | |
| Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year | 1 year |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Marisa Couluris, DO | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
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Subjects recruited from SunCoast Community Clinical Oncology Program (CCOP) Research Base affiliated CCOP members located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan | 50 mg tablets of losartan taken daily by mouth for 1 year losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan | 50 mg tablets of losartan taken daily by mouth for 1 year losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year |
| 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 Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year | Forced vital capacity (FVC) must be >= 50% at baseline. Stable FVC response is defined as a -5% change in FVC from baseline up to a +5% change from baseline. Improved FVC response is defined as 5% or greater increase in the predicted value of FVC on pulmonary function testing following 12 months of treatment. | Patients who received losartan for 12 months | Posted | Count of Participants | Participants | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Losartan | 50 mg tablets of losartan taken daily by mouth for 1 year losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to disease progression | Immune system disorders | MedDRA 10.0 | Systematic Assessment | 1 subject died after 6 months on study. Death was deemed due to disease progression and unrelated to study procedures/study agent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment | 1 subject experienced a rash on study that resolved shortly after presentation. |
A future phase II study is necessary to establish losartan's effect on IPF, due to a small number of patients and lack of controls to establish statistically significant efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Krischer, Principal Investigator | SunCoast CCOP Research Base | 813-396-9245 | ccop@epi.usf.edu |
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| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year | This index measures a patient's degree of breathlessness related to their activities of daily living including their functional impairment and their magnitude of task and effort. | 1 year |
| Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year | 1 year |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| FVC% Predicted | Mean | Standard Deviation | Percentage |
|
| DLCO% Predicted | Mean | Standard Deviation | Percentage |
|
| 6MWT Distance | Mean | Standard Deviation | meters |
|
| Chronic O2 Supplementation | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year | Patients who received losartan for 12 months. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year | Patients who received losartan for 12 months | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year | This index measures a patient's degree of breathlessness related to their activities of daily living including their functional impairment and their magnitude of task and effort. | Patients who received losartan for 12 months. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year | Patients who received losartan for 12 months. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 1 |
| 20 |
| 2 |
| 20 |
|
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment | 1 subject experienced fatigue that resolved shortly after presentation. |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |