Treprostinil Palmitil for Pulmonary Hypertension
(PALM-ILD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new inhalation powder treatment, Treprostinil Palmitil, to determine if it can improve exercise capacity in people with pulmonary hypertension linked to lung diseases like idiopathic interstitial pneumonia. Participants will receive either the treatment or a placebo once daily for 24 weeks. The trial targets individuals with a confirmed diagnosis of pulmonary hypertension due to interstitial lung disease who can walk between 100 and 500 meters in six minutes. This trial may suit those diagnosed with this specific lung disease and who face exercise challenges. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.
Do I have to stop taking my current medications for the trial?
The trial does not require you to stop your current medications. However, if you are taking medications for your underlying disease or certain other treatments, you should have been on them for at least 90 days and on a stable dose for at least 30 days before the trial starts.
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 for people. In a previous study with patients who have pulmonary arterial hypertension (a type of high blood pressure affecting the lungs), TPIP demonstrated promising safety results. Most participants did not experience serious side effects, with common mild side effects including cough and mild throat irritation.
In studies with rats and dogs, TPIP provided a steady release of the drug in the lungs, leading to a long-lasting reduction in high blood pressure in the lungs without causing significant harm to the animals.
Overall, these findings suggest that TPIP is safe for humans, with few side effects reported in earlier studies.12345Why do researchers think this study treatment might be promising?
Treprostinil Palmitil Inhalation Powder is unique because it offers a new inhalation method for delivering treprostinil, which is different from traditional treatments like oral, subcutaneous, or intravenous options. This inhaled powder could potentially improve convenience and comfort for patients, making it easier for them to adhere to their treatment plan. Researchers are also excited because this form of administration might allow for more rapid absorption and targeted delivery to the lungs, which could enhance its effectiveness in treating pulmonary hypertension.
What evidence suggests that Treprostinil Palmitil might be an effective treatment for pulmonary hypertension?
Research has shown that Treprostinil Palmitil Inhalation Powder (TPIP), which participants in this trial may receive, is effective for conditions like pulmonary hypertension. In one study with patients who had pulmonary arterial hypertension (a type of high blood pressure in the lungs), TPIP reduced resistance in lung blood vessels by 35%, improving blood flow through the lungs. The treatment also enabled patients to walk farther in a set time, indicating better exercise ability. Additionally, it was linked to fewer episodes of lung disease worsening. These findings suggest that TPIP might improve exercise capacity in people with pulmonary hypertension.14678
Are You a Good Fit for This Trial?
Adults with pulmonary hypertension associated with interstitial lung disease (PH-ILD) can join this trial. They must have specific heart and lung pressure measurements, a confirmed diagnosis of PH-ILD by CT scan, and be able to walk a certain distance. Stable on current meds for their condition for at least 90 days is also required.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Treprostinil Palmitil Inhalation Powder or placebo once daily for 24 weeks
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 tests Treprostinil Palmitil Inhalation Powder (TPIP) against a placebo over 24 weeks to see if it improves the ability to exercise in adults with PH-ILD. Participants will receive either TPIP or placebo once daily.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive TPIP, once daily (QD), at a starting dose of 80 micrograms (μg) to maximum tolerated dose up to 1280 μg for 24 weeks.
Participants will receive a placebo matching TPIP QD for 24 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Insmed Incorporated
Lead Sponsor
Citations
Press Release
The Phase 2b study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH) was a randomized ...
NCT05649748 | An Extension Study of Treprostinil Palmitil ...
The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 ...
Late Breaking Abstract - A randomized, double-blind, placebo ...
Conclusions: This is the first global, randomized, placebo-controlled study of TPIP in pts with PAH. Data from this study will help inform the development of ...
Therapeutic options for patients with pulmonary hypertension ...
Treatment with inhaled treprostinil was also associated with improvement in time to clinical worsening, fewer exacerbations of underlying lung ...
5.
conferences.medicom-publishers.com
conferences.medicom-publishers.com/specialisation/respiratory/phase-2b-results-confirm-the-efficacy-of-treprostinil-palmitil-inhalation-powder-in-pulmonary-arterial-hypertension/Phase 2b results confirm the efficacy of treprostinil palmitil ...
“The study showed a positive effect on the primary endpoint, with a 35% reduction in pulmonary vascular resistance alongside improvement in 6- ...
Safety, Tolerability, and Pharmacokinetics of Treprostinil ...
In rat and dog models of pulmonary hypertension, TP provided sustained treprostinil release in the lung and demonstrated prolonged reduction of ...
NCT07179380 | Efficacy and Safety Study of Treprostinil ...
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung ...
8.
dovepress.com
dovepress.com/therapeutic-potential-of-treprostinil-inhalation-powder-for-patients-w-peer-reviewed-fulltext-article-DHPSTherapeutic potential of treprostinil inhalation powder | DHPS
This study was a multicenter, randomized trial comparing nebulized treprostinil versus placebo in 326 patients with pulmonary hypertension due ...
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