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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

September 19, 2009
August 2, 2011
September 2009
May 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00981747 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
July 2013
May 2013   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00981747
IPF-001
Yes
Alicia Gerke, MD, University of Iowa
University of Iowa
Pulmonary Fibrosis Foundation
Principal Investigator: Alicia K Gerke, MD University of Iowa
University of Iowa
August 2011

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