NCT00879879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 14, 2013

Completed
Last Updated

February 21, 2021

Status Verified

September 1, 2018

Enrollment Period

3 years

First QC Date

April 10, 2009

Results QC Date

August 9, 2013

Last Update Submit

February 18, 2021

Conditions

Precancerous Condition

Keywords

precancerous condition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year

    1 year

Study Arms (1)

Losartan

EXPERIMENTAL

50 mg tablets of losartan taken daily by mouth for 1 year

Drug: losartan

Interventions

losartanDRUG

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

Also known as: losartan potassium
Losartan

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Precancerous Conditions

Interventions

Losartan

Condition Hierarchy (Ancestors)

Neoplasms

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Jeffrey Krischer, Principal Investigator
Organization
SunCoast CCOP Research Base
ccop@epi.usf.edu
813-396-9245

Study Officials

  • Marisa Couluris, DO

    University of South Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 21, 2021

Results First Posted

October 14, 2013

Record last verified: 2018-09

Locations

US(1)