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PULSE-PHPF-001: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLEDCLINICAL STUDY TO ASSESS THE SAFETY AND EFFICACYOF PULSED, INHALED NITRIC OXIDE (iNO) IN SUBJECTS WITH PULMONARY HYPERTENSION ASSOCIATED WITH PULMONARY FIBROSIS ON LONG TERM OXYGEN THERAPY (PART 1 AND PART 2)

Study

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Description

This is a 16 week study of iNO vs placebo. Once the subject meets criteria, the subject will be required to visit the clinic once a month for 16 weeks. There is an open label extension available for this study in which the subject will be guaranteed to get the actual study drug. The subject must complete the main study to qualify for the open label extension. Study procedures that will be completed during the study are the completion of quality of life questionnaires, 6 minute walk tests, pulmonary function tests, echocardiograms and laboratory assessments. Study required testing will be paid for but the Sponsor. Most visits will take approximately 2 hours.

Details
Age

Adult

Eligibility

1) diagnosis of Pulmonary Fibrosis by high resolution CT scan 2) Can have pulmonary hypertension 3) must have been using O2 by nasal cannula at least 4 weeks prior to screening 4) must be able to perform a 6 minute walk test 5)Must be willing to use the inhalation device at least 12 hours per day. 6)Women must not be pregnant or lactating. Women of child bearing potential must be willing to take adequate precaution to prevent pregnancy 7) Must be between 18 and 85 years of age 8) Cannot have signs of worsening disease within 1 month prior to screening

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Todd Bull,  MD

Todd Bull, MD

Study ID

Protocol Number: 17-1863

More information available at ClinicalTrials.gov: NCT03267108

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