Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis - Full Text View

Sponsor:	University of Iowa
Collaborator:	Pulmonary Fibrosis Foundation
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00981747

Purpose

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.

Condition	Intervention	Phase
Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis	Drug: Sildenafil Drug: Losartan Drug: Sildenafil and Losartan Drug: Placebo pill	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Clinical Treatment Trial Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: idiopathic pulmonary fibrosis

MedlinePlus related topics: Pulmonary Fibrosis

Drug Information available for: Losartan Losartan potassium Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:

Six minute walk test [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Quality of Life Score [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

oxygenation (pO2) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in biomarkers (Brain natriuretic peptide,angiotensin II, insulin-like growth factor, 8-isoprostane in exhaled breath condensate) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Forced Vital Capacity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Diffusing Capacity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in Borg dyspnea scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2009
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sildenafil	Drug: Sildenafil Sildenafil 20mg three times per day for 3 months Other Names: Viagra Revatio
Experimental: Losartan	Drug: Losartan Losartan 25mg two times a day for 3 months Other Name: Cozaar: losartan
Experimental: Sildenafil and Losartan	Drug: Sildenafil and Losartan Sildenafil 20mg three times per day and Losartan 25mg two times per day. Other Names: Viagra, Revatio: sildenafil Cozaar: losartan
Placebo Comparator: Placebo	Drug: Placebo pill Placebo pill three times per day for 3 months Other Name: Placebo pill (sugar)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981747

Locations

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52246

Sponsors and Collaborators

University of Iowa

Pulmonary Fibrosis Foundation

Investigators

Principal Investigator:

Alicia K Gerke, MD

University of Iowa

More Information

No publications provided

Responsible Party:	Alicia Gerke, MD, University of Iowa
ClinicalTrials.gov Identifier:	NCT00981747 History of Changes
Other Study ID Numbers:	IPF-001
Study First Received:	September 19, 2009
Last Updated:	August 2, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Losartan
Sildenafil
Anti-Arrhythmia Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012