Ignite Creation Date:
2024-05-06 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03399604
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2018-01-03
Brief Title:
Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil
Sponsor:
Liquidia Technologies Inc
Organization:
Liquidia Technologies Inc
Study Overview
Official Title:
A Phase 3 Open-label Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861Treprostinil in Pulmonary Arterial Hypertension WHO Group 1 Patients
Status:
COMPLETED
Status Verified Date:
2024-07
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:
INSPIRE
Brief Summary:
The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861 a dry powder formulation of treprostinil in patients with Pulmonary Arterial Hypertension PAH
Detailed Description:
One of the greatest impediments to patient treatment satisfaction with current inhaled treprostinil therapy is inconvenience Currently PAH patients using inhaled treprostinil may require more than 36 breaths per day using a nebulizer requiring daily set up and cleaning The use of a discrete hand-held dry powder inhaler to deliver treprostinil to the lungs could represent a major improvement in convenience and patient satisfaction thereby improving the quality of life for PAH patients Liquidia is pursuing approval of LIQ861 an inhalation dry powder formulation of treprostinil that is produced using Liquidias PRINT Technology Particle Replication in Nonwetting Templates as an alternative to current inhaled treprostinil therapy for the treatment of patients with PAH WHO Group 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None