Efficacy and safety of iNO in Pulmonary Arterial Hypertension, v1.0
Research type
Research Study
Full title
A Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study To Determine Efficacy, Safety And Tolerability Of Pulsed, Inhaled Nitric Oxide (iNO) versus Placebo in Symptomatic Subjects With Pulmonary Arterial Hypertension (PAH): Inovation-1 (Part 1 and Part 2)
IRAS ID
202601
Contact name
Gerry Coghlan
Contact email
Sponsor organisation
Bellerophon Pulse Technologies LLC
Eudract number
2015-005223-90
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 30 days
Research summary
The PULSE-PAH004 clinical trial investigates the efficacy and safety of pulsed, inhaled nitric oxide (a combination product featuring an investigational medicinal product (NO) delivered through a CE marked device), in selected patients who have a confirmed diagnosis of PAH Group 1 who have either idiopathic PAH (IPAH), heritable PAH, drug and toxin-induced PAH, associated PAH (APAH) with connective tissue disease (CTD), APAH with repaired simple congenital systemic to pulmonary shunt (i.e., atrial septal defect, ventricular septal defect and/or patent ductus arteriosus; complete repair at least 1 year prior to Screening), APAH with human immunodeficiency virus (HIV), or APAH with portal hypertension. This trial includes men and women aged 18 to 80 years inclusive. Patients must show willingness to use the drug-device for at least 16 hours per day. Patients should be willing to continue on the new therapy until the last subject has completed week 18 assessments. The trial is in acute care hospitals with sites around the world. The patients will have assessments included 6 minute walk distance, spirometry, blood tests (including methaemaglobin measurement, in order to assess the blood's capacity of binding oxygen) and patient reported outcomes. This trial includes a placebo-treated comparator group.
REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/0908
Date of REC Opinion
6 Jun 2016
REC opinion
Favourable Opinion