Phase 2 Completed N=10 Diagnostic

Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide

Source: ClinicalTrials.gov NCT01092559 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jun 2013

Primary outcomePrimary: Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs. — 0 participants

Summary

This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial hypertension (PAH). All participants will receive inhaled nitric oxide in oxygen or nitric oxide in air delivered by nasal cannula. Hemodynamics, clinical laboratory and clinical assessment data will be collected on all participants to evaluate safety.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs.	—	—
PRIMARY Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation	10	—

Eligibility Criteria

Inclusion Criteria

Have a confirmed diagnosis of PAH, WHO Group 1.
WHO Functional Class II or III equivalent, PAH.
Have been clinically stable with regard to signs and symptoms of PAH for at least 30 days prior to RHC.
May be receiving approved mono therapies or combination PAH therapies.
Females that are surgically sterile or post-menopausal. Females of chil-bearing potential must have negative pregnancy test and must be practicing adequate birth control.

Exclusion Criteria

Have had a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin) for PAH added within (1) month of RHC.
Have any PAH medication except for anticoagulants discontinued within the week prior to RHC.
Have evidence of significant parenchymal lung disease as evidenced by pulmonary function tests within the last six months
CREST (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, telangiectasia) syndrome
Have a history of uncontrolled sleep apnea within three months of RHC.
Have a history of hemodynamically significant left-sided heart disease
Have evidence of left-sided heart disease
Have any other disease that is associated with pulmonary hypertension (e.g. congenital systemic-to-pulmonary shunt, sickle cell anemia, schistosomiasis).
Documented uncontrolled systemic hypertension as evidenced by systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
Have used prescription appetite suppressants within 3 months prior to wean/transition.
Have chronic kidney disease stage IV or worse or the requirement for dialysis.
Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
Have had an atrial septostomy.
Have anemia (hemoglobin <10 g/dL), active infection or any other ongoing condition that would interfere with the interpretation of study assessments.
Have any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, renal dialysis, etc.).
Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial
Participant is pregnant or lactating
Significant, ongoing alcohol or drug abuse.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01092559). 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. Informational only — not medical advice.