Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00981747
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : March 30, 2017
Pulmonary Fibrosis Foundation
Information provided by (Responsible Party):
Alicia Gerke, University of Iowa

September 19, 2009
September 22, 2009
March 30, 2017
September 2009
December 2016   (Final data collection date for primary outcome measure)
  • Six minute walk test [ Time Frame: Every 3 months ]
  • Quality of Life Score [ Time Frame: Every 3 months ]
Six minute walk test [ Time Frame: Every 3 months ]
Complete list of historical versions of study NCT00981747 on Archive Site
  • oxygenation (pO2) [ Time Frame: 3 months ]
  • Change in biomarkers (Brain natriuretic peptide,angiotensin II, insulin-like growth factor, 8-isoprostane in exhaled breath condensate) [ Time Frame: 3 months ]
  • Forced Vital Capacity [ Time Frame: 3 months ]
  • Diffusing Capacity [ Time Frame: 3 months ]
  • Change in Borg dyspnea scale [ Time Frame: 3 months ]
Not Provided
Not Provided
Not Provided
Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis
A Clinical Treatment Trial Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis
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.
Not Provided
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Idiopathic Pulmonary Fibrosis
  • Pulmonary Fibrosis
  • Drug: Sildenafil
    Sildenafil 20mg three times per day for 3 months
    Other Names:
    • Viagra
    • Revatio
  • Drug: Losartan
    Losartan 25mg two times a day for 3 months
    Other Name: Cozaar: 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
  • Drug: Placebo pill
    Placebo pill three times per day for 3 months
    Other Name: Placebo pill (sugar)
  • Experimental: Sildenafil
    Intervention: Drug: Sildenafil
  • Experimental: Losartan
    Intervention: Drug: Losartan
  • Experimental: Sildenafil and Losartan
    Intervention: Drug: Sildenafil and Losartan
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Alicia Gerke, University of Iowa
University of Iowa
Pulmonary Fibrosis Foundation
Principal Investigator: Alicia K Gerke, MD University of Iowa
University of Iowa
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP