Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis
Vasodilator Therapy and Exercise Tolerance in IPF Patients
1 other identifier
interventional
29
1 country
1
Brief Summary
Medicines that decrease blood pressure in the lungs may help idiopathic pulmonary fibrosis (IPF) patients function better. This study will test whether sildenafil improves the ability to exercise in patients with pulmonary fibrosis of unknown cause.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2006
Typical duration for phase_2
1 active site
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
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 31, 2006
CompletedFirst Posted
Study publicly available on registry
August 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
October 6, 2014
CompletedNovember 1, 2017
September 1, 2017
2.3 years
July 31, 2006
September 10, 2013
September 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in 6-minute Walk Test
Distance in meters -- Distance (meters) walked in 6 minutes
0 - 6 months
Secondary Outcomes (1)
Dyspnea Score (Borg Scale)
0 - 6 months
Study Arms (2)
Sildenafil
EXPERIMENTALSildenafil 20 mg tid orally
Placebo
PLACEBO COMPARATORIdentical Placebo 20 mg tid orally
Interventions
Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of IPF
- years of age
- minute walk distance 150-500 m
- FVC 40-90% predicted
- DLCO 30-90% predicted
You may not qualify if:
- Severe pulmonary hypertension
- Severe heart failure
- FEV1/FVC \< 0.7
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Medical Center, Miami
Miami, Florida, 33125, United States
Related Publications (2)
Jackson RM, Glassberg MK, Ramos CF, Bejarano PA, Butrous G, Gomez-Marin O. Sildenafil therapy and exercise tolerance in idiopathic pulmonary fibrosis. Lung. 2010 Apr;188(2):115-23. doi: 10.1007/s00408-009-9209-8. Epub 2009 Dec 12.
PMID: 20012639RESULTJackson R, Ramos C, Gupta C, Gomez-Marin O. Exercise decreases plasma antioxidant capacity and increases urinary isoprostanes of IPF patients. Respir Med. 2010 Dec;104(12):1919-28. doi: 10.1016/j.rmed.2010.07.021. Epub 2010 Aug 23.
PMID: 20739168RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert M Jackson, ACOS/R
- Organization
- Miami VAHS
Study Officials
- PRINCIPAL INVESTIGATOR
Robert M Jackson, MD
VA Medical Center, Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2006
First Posted
August 2, 2006
Study Start
July 1, 2006
Primary Completion
October 1, 2008
Study Completion
June 1, 2009
Last Updated
November 1, 2017
Results First Posted
October 6, 2014
Record last verified: 2017-09