Ignite Creation Date:
2024-05-06 @ 1:04 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01728220
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2012-11-13
Brief Title:
Two-Part Dose-Confirming Study of Pulsed Inhaled Nitric Oxide in Subjects With WHO Group 3 Pulmonary Hypertension Associated With COPD
Sponsor:
Bellerophon Pulse Technologies
Organization:
Bellerophon
Study Overview
Official Title:
A Placebo-Controlled Double-Blind Parallel Randomized Two-Part Clinical Dose-Confirming Study Of Pulsed Inhaled Nitric Oxide iNO In Subjects With World Health Organization WHO Group 3 Pulmonary Hypertension PH Associated With Chronic Obstructive Pulmonary Disease COPD On Long Term Oxygen Therapy LTOT INHALE 1
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a placebo-controlled double-blind parallel randomized two-part dose-confirming clinical study characterizing the pharmacodynamic effects of pulsed iNO using the combination product inhaled nitric oxideINOpulse DS-C vs placebo in subjects with World Health Organization WHO Group 3 pulmonary hypertension PH associated with Chronic Obstructive Pulmonary Disease COPD on Long Term Oxygen Therapy LTOT
Detailed Description:
This two-part study is designed to confirm the dose of inhaled nitric oxide NO administered through an investigational pulsed delivery device INOpulse DS-C that results in decreased pulmonary arterial systolic pressure PASP without significantly affecting systemic oxygenation
In Part A 80 subjects will be randomized to 1of 4 treatment groups in a 1111 ratio with 20 subjects in each treatment group Subjects assigned to an iNO group will receive pulsed iNO at a dose of 0003 mgkg IBWhr 0010 mgkg IBWhr or 0015 mgkg IBWhr with a set pulse width PW of 260 milliseconds ms Part A subjects assigned to the placebo group will receive nitrogen N2 at a randomly assigned device setting of 0003 0010 or 0015 mgkg IBWhr with a set PW of 260 ms
Subjects who were randomized in Part A are permitted to participate in Part B of the study Subjects will need to be re-screened and re-randomized for Part B participation
In Part B 60 subjects will be randomized to 1 of 3 treatment groups in a 111 ratio with 20 subjects in each treatment group Subjects assigned to an iNO group will receive pulsed iNO at either 0030 mgkg IBWhr or 0075 mgkg IBWhr with a set PW of 260 ms Part B subjects assigned to placebo will receive N2 at a randomly assigned device setting of 0030 mgkg IBWhr or 0075 mgkg IBWhr with a set PW of 260 ms
Part B will use a skewed block randomization scheme with 10 blocks of 6 subjects as follows
Blocks 1-3 3 subjects at 0030 mgkg IBWhr 1 subject at 0075 mgkg IBWhr and 2 subjects randomly assigned to placebo either 0030 or 0075 mgkg IBWhr
Blocks 4-7 2 subjects at 0030 mgkg IBWhr 2 subjects at 0075 mgkg IBWhr and 2 subjects randomly assigned to placebo either 0030 or 0075 mgkg IBWhr
Blocks 8-10 1 subject at 0030 mgkg IBWhr 3 subjects at 0075 mgkg IBWhr and 2 subjects randomly assigned to placebo either 0030 or 0075 mgkg IBWhr
In Part A 80 subjects will be randomized to 1of 4 treatment groups in a 1111 ratio with 20 subjects in each treatment group Subjects assigned to an iNO group will receive pulsed iNO at a dose of 0003 mgkg IBWhr 0010 mgkg IBWhr or 0015 mgkg IBWhr with a set pulse width PW of 260 milliseconds ms Part A subjects assigned to the placebo group will receive nitrogen N2 at a randomly assigned device setting of 0003 0010 or 0015 mgkg IBWhr with a set PW of 260 ms
Subjects who were randomized in Part A are permitted to participate in Part B of the study Subjects will need to be re-screened and re-randomized for Part B participation
In Part B 60 subjects will be randomized to 1 of 3 treatment groups in a 111 ratio with 20 subjects in each treatment group Subjects assigned to an iNO group will receive pulsed iNO at either 0030 mgkg IBWhr or 0075 mgkg IBWhr with a set PW of 260 ms Part B subjects assigned to placebo will receive N2 at a randomly assigned device setting of 0030 mgkg IBWhr or 0075 mgkg IBWhr with a set PW of 260 ms
Part B will use a skewed block randomization scheme with 10 blocks of 6 subjects as follows
Blocks 1-3 3 subjects at 0030 mgkg IBWhr 1 subject at 0075 mgkg IBWhr and 2 subjects randomly assigned to placebo either 0030 or 0075 mgkg IBWhr
Blocks 4-7 2 subjects at 0030 mgkg IBWhr 2 subjects at 0075 mgkg IBWhr and 2 subjects randomly assigned to placebo either 0030 or 0075 mgkg IBWhr
Blocks 8-10 1 subject at 0030 mgkg IBWhr 3 subjects at 0075 mgkg IBWhr and 2 subjects randomly assigned to placebo either 0030 or 0075 mgkg IBWhr
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None