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Prostacyclin Analogue

Treprostinil for Pulmonary Hypertension

Phase 2
Waitlist Available
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females must be ≥ 18 to ≤ 80 years of age at the time of signing the informed consent form (ICF).
Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD) (including idiopathic interstitial pneumonia [IIP], idiopathic pulmonary fibrosis [IPF], connective tissue disease [CTD], sarcoidosis).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-, during, and post- 6-minute walk test (6mwt) at baseline, week 5, week 10, and week 16
Awards & highlights

Study Summary

This trial is testing if treprostinil palmitil inhalation powder is safe and tolerable compared to a placebo.

Who is the study for?
Adults aged 18-80 with pulmonary hypertension linked to interstitial lung disease can join this trial. They must not have a primary COPD diagnosis, allergies to the study drug or its components, recent use of certain heart and lung medications, severe heart issues, high oxygen needs, or substance abuse history. Participants should be able to perform required tests like the 6-minute walk test.Check my eligibility
What is being tested?
The trial is testing Treprostinil Palmitil inhalation powder against a placebo for safety and tolerability in patients with pulmonary hypertension due to interstitial lung disease. It aims to see if this new treatment is safe for patients and doesn't cause too many problems when used.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions related to Treprostinil Palmitil inhalation powder compared with those taking a placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old.
Select...
I have high blood pressure in my lungs due to lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-, during, and post- 6-minute walk test (6mwt) at baseline, week 5, week 10, and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-, during, and post- 6-minute walk test (6mwt) at baseline, week 5, week 10, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Saturation of Peripheral Capillary Oxygenation (SpO2) Levels
Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs)
Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs)
Secondary outcome measures
AUClast of Treprostinil
AUCtau of Treprostinil
AUC∞ of Treprostinil
+13 more

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT03055221
31%
Pyrexia
25%
Catheter site infection
19%
Device-related infection
19%
Nausea
19%
Abdominal discomfort
19%
Catheter site pain
19%
Device dislocation
19%
Cough
13%
Device-related sepsis
13%
Diarrhoea
13%
Vomiting
13%
Pain in extremity
13%
Pain in jaw
13%
Dyspnea
13%
Oropharyngeal pain
13%
Bacteraemia
13%
Headache
6%
Pyogenic granuloma
6%
Sepsis
6%
Endocarditis
6%
Localized infection
6%
Lower respiratory tract infection
6%
Nasopharyngitis
6%
Pleural effusion
6%
Pleurisy
6%
Pulmonary arterial hypertension
6%
Abortion induced
6%
Thrombophlebitis
6%
Venous thrombosis
6%
Cyanosis
6%
Lacrimation increased
6%
Local swelling
6%
Wound infection
6%
Wound haemorrhage
6%
Weight decreased
6%
Muscle spasms
6%
Decreased appetite
6%
Coagulopathy
6%
Pulmonary hypertension
6%
Cardiac failure acute
6%
Cardiac failure congestive
6%
Right ventricular failure
6%
Vertigo
6%
Catheter site swelling
6%
Chills
6%
Disease progression
6%
Infusion site pain
6%
Hepatomegaly
6%
Atypical pneumonia
6%
Pneumonia
6%
Septic shock
6%
Polymenorrhea
6%
Interstitial lung disease
6%
Lung consolidation
6%
Musculoskeletal chest pain
6%
Epistaxis
6%
Productive cough
6%
Rhinorrhoea
6%
Chest pain
6%
Haematuria
6%
Pain
6%
Oedema
6%
Insomnia
6%
Gynacomastia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intravenous Treprostinil

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treprostinil PalmitilExperimental Treatment1 Intervention
Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be titrated up to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be administered a placebo matching TPIP once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treprostinil Palmitil
2022
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Insmed IncorporatedLead Sponsor
42 Previous Clinical Trials
7,163 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on participant numbers for this clinical trial?

"The trial is seeking 32 eligible participants, who may join from either USA008 in Aurora, Colorado or USA016 in Mineola, New york."

Answered by AI

Who can be accepted as a participant in this research?

"To be eligible to partake in this medical study, patients must have hypertension and pulmonary disease while also falling within the age range of 18-75. Currently there are 32 available spots for recruitment."

Answered by AI

Is there an open call for participants in this medical trial?

"This clinical trial is actively recruiting, as evidenced by the information hosted on clinicaltrials.gov. The research first went live on January 15th 2023 and has been resubmitted for review recently, with its last update being November 23rd 2022."

Answered by AI

To what degree is Treprostinil Palmitil harmless to human subjects?

"Based on our internal evaluations, the safety of Treprostinil Palmitil was rated at a 2. This rating is because there are no findings to support efficacy but some evidence suggesting it may be safe for human use in Phase 2 trials."

Answered by AI

Does this trial include elderly people in its enrollment criteria?

"This study is welcoming individuals aged 18 or over, but no older than 75 to enroll in the trial."

Answered by AI

How many locations have been identified to manage this clinical trial?

"This medical research is accepting participants from USA008 in Aurora, Colorado; USA016 in Mineola, New york and USA002 in Atlanta, Georgia. Additionally they are recruiting patients at 11 other sites."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
USA007
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
2022. "A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05176951.
~17 spots leftby Apr 2025
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