Precancerous Condition
Conditions
Keywords
precancerous condition
Brief summary
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.
Detailed description
OBJECTIVES: * Evaluate the effects of losartan potassium on disease progression in patients with idiopathic pulmonary fibrosis. * Determine the safety of this drug in these patients. 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.
Interventions
DRUGlosartan
50 mg losartan taken daily by mouth in capsule form for 1 year
Sponsors
National Cancer Institute (NCI)
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 21 years * Diagnosis of idiopathic pulmonary fibrosis * Patients taking Coumadin and/or N-acetylcysteine may participate in the study * Baseline forced vital capacity (FVC) must be greater than or equal to 50% * Baseline 6 minute walk test distance walked must be greater than or equal to 200 meters not requiring greater than 6 lpm of oxygen
Exclusion criteria
* Pregnant, intending to become pregnant or breastfeeding * Current or previous smoker of cigarettes or marijuana that recently quit within the last 6 months prior to enrollment * Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker * Taking losartan or any other angiotensin II receptor blocker * Baseline systolic blood pressure \< 100 mmHg * Currently taking or has taken immunosuppressant agents within the last month such as azathioprine, cyclophosphamide, colchicine and/or prednisone * History of lung transplant * History of kidney failure or liver disease * Inability to attend clinic visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year | 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. |
| Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year | 1 year | — |
Countries
United States
Participant flow
Recruitment details
Subjects recruited from SunCoast Community Clinical Oncology Program (CCOP) Research Base affiliated CCOP members located in the United States.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Losartan |
|---|---|
| 6MWT Distance | 464.89 meters STANDARD_DEVIATION 249.54 |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 6.24 |
| Chronic O2 Supplementation | 9 Participants |
| DLCO% Predicted | 43.65 Percentage STANDARD_DEVIATION 16.91 |
| FVC% Predicted | 73.96 Percentage STANDARD_DEVIATION 3.76 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
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.
Time frame: 1 year
Population: Patients who received losartan for 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Losartan | Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year | Stable | 7 Participants |
| Losartan | Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year | Improved | 5 Participants |
| Losartan | Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year | Deteriorated | 5 Participants |
Secondary
Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year
Time frame: 1 year
Population: Patients who received losartan for 12 months.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Losartan | Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year | Stable | 10 Participants |
| Losartan | Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year | Improved | 2 Participants |
| Losartan | Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year | Deteriorated | 5 Participants |
Secondary
Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year
Time frame: 1 year
Population: Patients who received losartan for 12 months.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Losartan | Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year | Stable | 6 Participants |
| Losartan | Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year | Improved | 5 Participants |
| Losartan | Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year | Deteriorated | 6 Participants |
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.
Time frame: 1 year
Population: Patients who received losartan for 12 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Losartan | Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year | Stable | 5 Participants |
| Losartan | Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year | Improved | 2 Participants |
| Losartan | Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year | Deteriorated | 10 Participants |
Secondary
Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year
Time frame: 1 year
Population: Patients who received losartan for 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Losartan | Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year | Stable | 8 Participants |
| Losartan | Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year | Improved | 2 Participants |
| Losartan | Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year | Deteriorated | 7 Participants |