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Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pulmonary Fibrosis Foundation
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00981747
First received: September 19, 2009
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  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 2
Phase 3

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:

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 May 21, 2013