Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

Precancerous Condition Clinical Trial

Official title:

Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879879
• Other study ID #: SCUSF 0108 Pilot
• Secondary ID: SCUSF-PILOT-0108
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: March 2012

Study information

• Verified date: September 2018
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Precancerous Condition
• Precancerous Conditions
• Pulmonary Fibrosis

Intervention

Drug:
• losartan
50 mg losartan taken daily by mouth in capsule form for 1 year

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 year
Secondary	Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year		1 year
Secondary	Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year		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.	1 year
Secondary	Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year		1 year