NCT00352482

Brief Summary

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's ability to breathe. Currently, no medications can reverse the damage to the lungs caused by IPF, but individuals are encouraged to engage in moderate exercise to strengthen lung function. This study will evaluate the effectiveness of sildenafil at improving exercise tolerance and breathing difficulties in individuals with IPF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 29, 2016

Status Verified

December 1, 2007

First QC Date

July 13, 2006

Last Update Submit

July 28, 2016

Conditions

Pulmonary FibrosisHypertension, Pulmonary

Keywords

Pulmonary HypertensionIdiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 6-minute walk distance (measured at Week 3)

Secondary Outcomes (7)

  • Oxygen saturation (SpO2) at rest

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

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

  • Recovery time (measured during 6-minute walk test)

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

  • +2 more secondary outcomes

Interventions

Sildenafil (50 mg)DRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Pulmonary Outpatient Clinic,

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Collard HR, Anstrom KJ, Schwarz MI, Zisman DA. Sildenafil improves walk distance in idiopathic pulmonary fibrosis. Chest. 2007 Mar;131(3):897-899. doi: 10.1378/chest.06-2101.

    PMID: 17356110DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary FibrosisHypertension, PulmonaryIdiopathic Pulmonary Fibrosis

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • David A. Zisman, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 14, 2006

Study Start

November 1, 2004

Study Completion

July 1, 2007

Last Updated

July 29, 2016

Record last verified: 2007-12

Locations

US(1)