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Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

Information source: University of South Florida
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Precancerous Condition

Intervention: losartan (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of South Florida

Official(s) and/or principal investigator(s):
Marisa Couluris, DO, Principal Investigator, Affiliation: University of South Florida

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.

Clinical Details

Official title: Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year

Secondary outcome:

Diffusion Capacity of Carbon Monoxide (DLCO)

Total Lung Capacity by Plethysmography

Baseline/Transition Dyspnea Index

6-minute Walk Test Results

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

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Cincinnati, Cincinnati, Ohio 45267, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2009
Last updated: August 9, 2013

Page last updated: August 20, 2015

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