This trial is active, not recruiting.

Conditions idiopathic pulmonary fibrosis, pulmonary fibrosis
Treatments sildenafil, losartan, sildenafil and losartan, placebo pill
Phase phase 2/phase 3
Sponsor University of Iowa
Collaborator Pulmonary Fibrosis Foundation
Start date September 2009
End date May 2016
Trial size 40 participants
Trial identifier NCT00981747, IPF-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
sildenafil Viagra
Sildenafil 20mg three times per day for 3 months
losartan Cozaar: losartan
Losartan 25mg two times a day for 3 months
sildenafil and losartan Viagra, Revatio: sildenafil
Sildenafil 20mg three times per day and Losartan 25mg two times per day.
(Placebo Comparator)
placebo pill Placebo pill (sugar)
Placebo pill three times per day for 3 months

Primary Outcomes

Six minute walk test
time frame: Every 3 months
Quality of Life Score
time frame: Every 3 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Clinical Treatment Trial Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis
Principal investigator Alicia K Gerke, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Iowa.