OLE study in participants with pulmonary arterial hypertension
Research type
Research Study
Full title
An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension
IRAS ID
1006465
Contact name
Colin Urquhart
Contact email
Sponsor organisation
Insmed Incorporated
Eudract number
2022-001951-18
Clinicaltrials.gov Identifier
Research summary
Pulmonary arterial hypertension (PAH) is a debilitating progressive disease that causes a wide range of non-specific symptoms including, dyspnoea, shortness of breath, chest pain, fatigue, generalized weakness, and exertional syncope, severely affecting the patient’s physical mobility, emotional and social well-being, ability to perform activities of daily living and overall quality of life. Pharmacological treatments are available to mitigate disease symptoms and slow disease progression, but treatment-related adverse events (AEs), inconvenience, and side effects can be treatment limiting and negatively influence the patient’s daily life.
The purpose of this study is to evaluate treprostinil palmitil inhalation powder (TPIP), an experimental drug being tested for treatment of PAH, for the following reasons: (1) to learn how safe TPIP is for people with PAH to take for a long time and to learn if TPIP helps PAH to get better (or makes it worse), (2) find out if TPIP is well tolerated (has few side effects), (3) learn more about TPIP and how it works in the human body and the substances it produces (“biomarkers”), and (4) to measure the amount of TPIP in the body (pharmacokinetics) and to learn more about how the body reacts to the study drug. This is the same drug that was studied in the previous original/main study, INS1009-202.
There are six research sites, and six participants are planned to be involved in the UK.
All participants in the study will complete the same study procedures.
The overall treatment period is up to 24 months followed by a 4-week follow-up period.REC name
London - Chelsea Research Ethics Committee
REC reference
22/LO/0831
Date of REC Opinion
24 Apr 2023
REC opinion
Further Information Favourable Opinion