Phase 2 N=29 Randomized Quadruple-blind Treatment

Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis

Alveolitis, Fibrosing · Fibrosis, Pulmonary · Hypertension, Pulmonary

Bottom Line

View on ClinicalTrials.gov: NCT00359736 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Change in 6-minute Walk Test — -26; -7 meters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: sildenafil (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in 6-minute Walk Test	-26; -7	—
SECONDARY Dyspnea Score (Borg Scale)	0.86; 0.38; 0.89; 0.15	—

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.

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of IPF
40-85 years of age
6-minute walk distance 150-500 m
FVC 40-90% predicted
DLCO 30-90% predicted

Exclusion Criteria

Severe pulmonary hypertension
Severe heart failure
FEV1/FVC < 0.7

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00359736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.