Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl. (NCT01265888) | Clinical Trial Compass
CompletedPhase 2
Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl.
United States31 participantsStarted 2011-03
Plain-language summary
A Phase 2 open label, dose escalation study to find the minimally and maximum effective dose (dose beyond which no further effect on PVR is seen) of inhaled nitric oxide generated by the GeNOsyl® System compared to placebo.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
PAH and PH-IPF
* WHO Functional Class (or equivalent classification) II - IV.
* Subjects using supplemental oxygen must be receiving a stable course of therapy for a minimum of 14 days prior to study drug administration.
* All subjects' oxygen saturation must be \> or = to 88% at time of treatment
* Echocardiogram within 6 months of baseline showing no signs of clinically significant left sided heart disease
* Females of child-bearing potential with a negative urine pregnancy test, or a documented surgical sterilization, or is post-menopausal prior to administration of investigational product. Females of childbearing potential must be practicing adequate birth control.
PAH (WHO Group 1) ONLY-Inclusion
* Documented diagnosis of WHO Group 1 PAH, (limited to, idiopathic, heritable, drug and toxin induced, associated with connective tissue disease, portal hypertension, repaired congenital heart disease, HIV); documented by a previous RHC and hemodynamics consistent with PAH, WHO Group 1
* Pulmonary Function Testing within 6 months prior to screening/enrollment shows no evidence of interstitial lung disease (TLC\<70%) or obstructive lung disease (FEV1/FVC ratio \<50%)
* Receiving a stable course of approved PAH oral mono therapies for a minimum of 14 days prior to treatment period
* Must be 18-80 year of age
PH-IPF (WHO Group 3) ONLY-Inclusion
* Documented diagnosis of probable or definite IPF using ATS/ERS criteria
* Previous transbronchial biopsy, if pe…
What they're measuring
1
Identify the minimally and maximum effective doses of inhaled nitric oxide generated by the GeNOsyl® System compared to placebo.
Timeframe: through end of Right Heart Catheterization procedure (Treatment Phase approximately 3 hours)