Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether combination therapy with sildenafil and losartan can improve function and exercise tolerance in patients with idiopathic pulmonary fibrosis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alicia Gerke; University of Iowa
• Collaborator: Pulmonary Fibrosis Foundation
• Treatments: Losartan; Sildenafil Citrate

Criteria

Inclusion Criteria:

• Age 18-99

• Have not taken any of the study medications in the past 6 weeks

• Diagnosed with idiopathic pulmonary fibrosis

Exclusion Criteria:

• FVC<50%, DLco <30% or FEV1/FVC ratio <65%

• Greater amount of emphysema than fibrotic change on chest CT scan

• Acute myocardial infarction within the past 6 months

• Nitrate use

• Contraindications, hypersensitivity, or allergic reaction to any study medication

• Presence of aortic stenosis

• Life-threatening arrhythmia within 1 month of evaluation

• Diabetes requiring insulin therapy

• Second-degree or third-degree atrioventricular block on electrocardiogram

• Echocardiographic evidence of severe pulmonary hypertension (>50mmHg) • Severe terminal illness (survival predicted to be less than 1 year)

• Severe congestive heart failure

• Renal impairment (creatinine >2.0 mg/dl)

• Moderate to severe hepatic impairment

• Concurrent treatment with immunosuppressive, cytotoxic, or investigational agents.

• Pregnant or Breastfeeding (Women of childbearing age must use effective form of birth control or abstinence during study participation)

• History of acute exacerbation of IPF

• Current enrollment in another investigational protocol

• Acute or chronic impairment other than dyspnea that limits the patient's ability to perform the six minute walk test

• Current drug or alcohol dependence

• Initiation of pulmonary rehabilitation within 30 days of enrollment. Subjects currently undergoing maintenance pulmonary rehabilitation at study entry will be asked to maintain their levels of rehabilitation for the duration of the trial

• Treatment of pulmonary hypertension with prostaglandins, endothelin-1 antagonists, or any other phosphodiesterase inhibitor within 30 days of enrollment

• Addition or discontinuation of calcium channel blockers, digitalis, diuretics or vasodilators within 30 days of enrollment. Dosage must be stable for 7 days prior to enrollment (except for diuretics)

• Listed for lung transplantation

• Due to drug interactions, all of the following agents will be prohibited:

alpha-blockers, endothelin-1 antagonists, and CYP3A4 inhibitors

• Resting oxygen saturation of <92% with greater than 6 liters of supplemental oxygen