Treprostinil Palmitil for Pulmonary Hypertension
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new inhalation powder, Treprostinil Palmitil, to assess its safety and tolerability for long-term use in individuals with pulmonary hypertension linked to interstitial lung disease (PH-ILD). Participants will use the treatment daily for up to two years to evaluate its effects. It is suitable for those who completed the initial study related to this treatment and are not currently using other specific pulmonary hypertension medications. Participants must have finished the earlier study without experiencing severe side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Is there any evidence suggesting that Treprostinil Palmitil Inhalation Powder is likely to be safe for humans?
Research has shown that Treprostinil Palmitil Inhalation Powder (TPIP) is generally safe and well-tolerated. In one study, 79.3% of participants used the highest dose tested, indicating that most handled the treatment well. Mild side effects, such as headaches, were common, but no severe or serious side effects occurred.
Another study supported these findings, with 69% of participants experiencing mild side effects and 16.7% having moderate ones. Importantly, no severe side effects were noted. These results suggest that TPIP is safe for treating conditions like pulmonary hypertension.12345Why do researchers think this study treatment might be promising for pulmonary hypertension?
Treprostinil Palmitil Inhalation Powder (TPIP) is unique because it offers a new delivery method for treating pulmonary hypertension. Unlike standard treatments that are often delivered via intravenous or subcutaneous routes, TPIP is administered as an inhalation powder, potentially making it more convenient and less invasive for patients. Additionally, the once-daily dosing of TPIP may improve patient adherence compared to more frequent dosing schedules of existing therapies. Researchers are excited about TPIP because it could simplify treatment regimens and enhance the quality of life for those with pulmonary hypertension.
What evidence suggests that Treprostinil Palmitil Inhalation Powder might be an effective treatment for pulmonary hypertension?
Research has shown that Treprostinil Palmitil Inhalation Powder (TPIP), which participants in this trial will receive, may help treat pulmonary hypertension linked to interstitial lung disease. Studies have found that TPIP can reduce fatigue during physical activities by improving exercise capacity. In one study, the treatment demonstrated lasting improvement in various effectiveness measures and was well tolerated, causing few side effects. TPIP is designed to release medication slowly in the lungs, reducing the frequency of doses. This feature could simplify daily management of the condition. Overall, evidence suggests TPIP could be a helpful option for those with this type of pulmonary hypertension.678910
Who Is on the Research Team?
Study Director
Principal Investigator
Insmed Incorporated
Are You a Good Fit for This Trial?
This trial is for people with pulmonary hypertension linked to interstitial lung disease who have already finished a previous related study (INS1009-311). Participants must be able to give consent and agree not to join other clinical trials during this study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Titration
Participants undergo an initial double-dummy titration with the stable dose from the lead-in study and either TPIP or placebo
Treatment
Participants receive open-label TPIP at a stable maintenance dose with optional escalation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Treprostinil Palmitil Inhalation Powder
Trial Overview
The study is testing the long-term safety of Treprostinil Palmitil Inhalation Powder (TPIP) compared to placebo in people with PH-ILD. All participants previously took part in an earlier TPIP trial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants transitioning from study INS1009-311 (NCT07179380) will undergo an initial double-dummy titration with the stable dose from the lead-in study and either TPIP or placebo for 4 weeks. They will then receive open-label TPIP at a stable maintenance dose with optional escalation (80-1280 micrograms once daily) for the remainder of the 104-week treatment period.
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Who Is Running the Clinical Trial?
Insmed Incorporated
Lead Sponsor
Citations
1.
pulmonaryfibrosis.org
pulmonaryfibrosis.org/patients-caregivers/medical-and-support-resources/find-medical-care/care-center-new/NCT07179380-2243362Efficacy and Safety Study of Treprostinil Palmitil Inhalation ...
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung ...
An open-label extension study to evaluate the safety, ...
TPIP is expected to provide prolonged release of treprostinil in the lungs with the aim of less frequent and more convenient dosing while ...
3.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-treprostinil-palmitil-inhalation-powder-tpip-in-pulmonary-arterial-hypertension-pahA Study of Treprostinil Palmitil Inhalation Powder (TPIP) In ...
The main purpose of this study is to evaluate the safety and tolerability of single dose of treprostinil palmitil inhalation powder (TPIP) ...
Insmed to Present Multiple Abstracts on Treprostinil Palmitil ...
Developed entirely in Insmed's laboratories, TPIP is being evaluated as a once-daily therapy for the treatment of patients with PAH, PH-ILD, and ...
Efficacy and Safety Study of Treprostinil Palmitil Inhalation ...
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung ...
6.
investor.insmed.com
investor.insmed.com/2021-02-19-Insmed-Announces-Topline-Results-from-Phase-1-Study-of-Treprostinil-Palmitil-Inhalation-Powder-TPIPInsmed Announces Topline Results from Phase 1 Study of ...
Data from the study demonstrated that TPIP was generally safe and well tolerated, with a pharmacokinetic profile that supports once-daily dosing ...
NCT05176951 | A Study to Evaluate the Safety and ...
The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo
B106-14 Population Pharmacokinetics Analysis of Treprostinil ...
Phase 2 trials demonstrated safety, tolerability, and efficacy of TPIP in pulmonary arterial hypertension (PAH) and pulmonary hypertension
Efficacy and Safety Study of Treprostinil Palmitil Inhalation ...
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults ...
Insmed Presents Data on TPIP Inhalation Drug for PAH | RT
Insmed will present 4 abstracts on treprostinil palmitil inhalation powder (TPIP) evaluated for PAH, PH-ILD, and rare pulmonary disorders.
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