N/A N=20 Treatment

Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

Precancerous Condition

Bottom Line

View on ClinicalTrials.gov: NCT00879879 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Oct 2013

Primary outcome: Primary: Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year — 7; 5; 5 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: losartan (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of South Florida
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year	7; 5; 5	—
SECONDARY Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year	10; 2; 5	—
SECONDARY Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year	8; 2; 7	—
SECONDARY Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year	5; 2; 10	—
SECONDARY Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year	6; 5; 6	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00879879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.