Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT00352482
• Date of registration: 13/07/2006
• Prospective Registration: No
• Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Public title: Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension
• Scientific title: Sildenafil Treatment in Patients With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - a Pilot Cross-over Study
• Date of first enrolment: November 2004
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00352482
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: David A. Zisman, MD
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion criteria

Inclusion Criteria:

- IPF, diagnosed according to the American Thoracic Society (ATS) and European
Respiratory Society (ERS) consensus statement (with or without surgical lung biopsy)

- Pulmonary hypertension, defined as mean pulmonary artery pressure (MPAP) greater than
or equal to 25 mm Hg by right heart catheterization (RHC)

Exclusion Criteria:

- Interstitial lung disease due to conditions other than IPF

- Recent lung or upper respiratory tract infection within 4 weeks of study entry

- Acute or chronic impairment other than dyspnea (e.g., angina pectoris, intermittent
claudication) limiting the ability to comply with study requirements (e.g., 6-minute
walk test)

- Known hypersensitivity to sildenafil

- Known or suspected coronary artery disease (CAD)

- Unstable angina

- Nitrate use

- Known or suspected aortic stenosis (AS)

- Known or suspected heart attack, stroke, or life-threatening arrythmias within 1
month of study entry

- Severe chronic heart failure, defined as New York Heart Association (NYHA) class
III/IV and/or left ventricular ejection fraction less than 25%

- Known penile deformities

- Known kidney or liver dysfunction

- Uncontrolled diabetes (blood glucose less than 60 mg/dl or greater than 300 mg/dl)

- Severe serum sodium abnormalities (serum sodium less than 130 mEq/L or greater than
150 mEq/L)

- Condition that may predispose participant to priapism (e.g., sickle cell anemia,
multiple myeloma, leukemia)

- Retinitis pigmentosa

- Known or suspected idiopathic hypertrophic subaortic stenosis (IHSS)

- Low blood pressure (systolic blood pressure [SBP] less than 100 mm Hg or diastolic
blood pressure [DBP] less than 50 mm Hg)

- Uncontrolled systemic high blood pressure (SBP greater than 180 mm Hg or DBP greater
than 100 mm Hg)

- Cardiopulmonary rehabilitation program started within 8 weeks of study entry or
likely to start prior to the conclusion of the study

- Treatment with an endothelin receptor antagonist, iloprost, epoprostenol, inhibitors
of CYP3A4 (e.g., cimetidine, erythromycin, ketoconazole, itraconazole, mibefradil),
protease inhibitors (e.g., amprenavir, indinavir, or ritonavir), rifampin,
alpha-blockers (e.g., doxazosin), or other phosphodiesterase-5 inhibitors

- Current use of alcohol, grapefruit juice, or St. John's wort

- Pregnant or breastfeeding



Age minimum: 19 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Pulmonary Fibrosis

Intervention(s)

Drug: Sildenafil (50 mg)

Primary Outcome(s)

6-minute walk distance (measured at Week 3)

Secondary Outcome(s)

Desaturation index (measured by the 6-minute walk distance multiplied by the SpO2 mean value)

Lowest SpO2 with exertion (measured during 6-minute walk test)

Oxygen saturation (SpO2) at rest

Mean SpO2 and area under the curve (measured during 6-minute walk test)

Total duration of SpO2 below 89% with exertion (measured during 6-minute walk test)

Level of breathlessness (measured by Borg dyspnea index questionnaire) (all measured at Week 3)

Recovery time (measured during 6-minute walk test)

Secondary ID(s)

414

P50HL067665-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors