Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01266265
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2010-12-22
Brief Title:
Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso Compared to Other FDA Approved PAH Therapies
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso Treprostinil Inhalation Solution
Status:
COMPLETED
Status Verified Date:
2016-01
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:
Aspire
Brief Summary:
A surveillance of respiratory tract related adverse events in patients treated with Tyvasotreprostinil Inhalation Solution versus other FDA approved therapies
Detailed Description:
A post marketing surveillance to determine the type and incidence of oronasopharyngeal or pulmonary adverse events that may occur in patients treated with commercially available Tyvasotreprostinil Inhalation Solution A comparison will be made to the type and incidence of events in patients receiving other FDA approved therapies for pulmonary arterial hypertension as a control measure
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