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.
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Insmed Incorporated
Lead Sponsor