Clinical trial NCT00879879: Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
Official title: Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Precancerous Condition
Keywords: precancerous condition
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year
timeFrame: 1 year
measure: Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year
timeFrame: 1 year
measure: Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year
timeFrame: 1 year
measure: Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year
timeFrame: 1 year
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of South Florida
name: Marisa Couluris, DO
role: PRINCIPAL_INVESTIGATOR
References: