Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis
Information source: University of Iowa
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis
Intervention: Sildenafil (Drug); Losartan and N-acetylcysteine (Drug); Sildenafil, Losartan, N-acetylcysteine (Drug); Placebo pill (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: University of Iowa Official(s) and/or principal investigator(s):
Alicia K Gerke, MD, Principal Investigator, Affiliation: University of Iowa
Gary W Hunninghake, MD, Principal Investigator, Affiliation: University of Iowa
Overall contact:
Alicia K Gerke, MD, Phone: 319-384-5282, Email: alicia-gerke@uiowa.edu
Summary
The purpose of this study is to determine whether combination therapy with N-acetylcysteine,
sildenafil, and losartan can improve function and exercise tolerance in patients with
idiopathic pulmonary fibrosis.
Clinical Details
Official title: A Clinical Treatment Trial Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
Primary outcome: Six minute walk test
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18-80
- Have not taken any of the study medications in the past 6 months
- Diagnosed with idiopathic pulmonary fibrosis within the past three years
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
Locations and Contacts
Alicia K Gerke, MD, Phone: 319-384-5282, Email: alicia-gerke@uiowa.edu
University of Iowa Hospitals and Clinics, Iowa City, Iowa 52246, United States; Recruiting
Emily Avgenackis, Phone: 319-384-6381, Email: emily-avgenackis@uiowa.edu
Lori Stout, RN, Phone: 319-384-5376, Email: lori-stout@uiowa.edu
Gary W Hunninghake, MD, Principal Investigator
Alicia K Gerke, MD, Principal Investigator
Additional Information
Starting date: September 2009
Ending date: July 2013
Last updated: September 19, 2009
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