Inhaled Treprostinil for Usual Interstitial Pneumonia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Usual Interstitial Pneumonia+5 More
Inhaled Treprostinil - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the safety and effectiveness of inhaled treprostinil in people with a lung disease called idiopathic pulmonary fibrosis.

Eligible Conditions
  • Usual Interstitial Pneumonia
  • Lung Diseases, Interstitial

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Week 52

Baseline to Week 52
Change in % Predicted FVC from Baseline to Week 52
Change in Absolute FVC from Baseline to Week 52
Change in K-BILD Questionnaire Score from Baseline to Week 52
Time to Clinical Worsening
Time to First Acute Exacerbation of IPF
Week 52
Overall Survival at Week 52

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Active Inhaled Treprostinil
44%Cough
28%Headache
25%Dyspnoea
18%Dizziness
15%Nausea
14%Fatigue
13%Diarrhea
12%Throat irritation
11%Oropharyngeal pain
9%Chest pain
8%Oedema peripheral
7%Upper respiratory tract infection
6%Epistaxis
6%N-terminal prohormone brain natriuretic peptide increased
5%Rhinorrhoea
5%Fall
5%Chest discomfort
4%Decreased appetite
2%Interstitial lung disease
2%Death
2%Acute respiratory failure
1%Hypervolaemia
1%Cardiac failure congestive
1%Pneumonia
1%Combined pulmonary fibrosis and emphysema
1%Pneumothorax
1%Hyperglycaemia
1%Left ventricular failure
1%Cerebral haemorrhage
1%Respiratory failure
1%Hypoxia
1%Sepsis
1%Chronic respiratory failure
1%Idiopathic pulmonary fibrosis
1%Pain in extremity
1%Syncope
1%Right ventricular failure
1%Cardiopulmonary failure
1%Tachycardia
1%Arrythmia
1%Acute myocardial infarction
1%Acute right ventricular failure
1%Cardiac arrest
1%Bradycardia
1%Bronchopulmonary aspergillosis
1%Cellulitis
1%Bronchitis
1%Cor pulmonale
1%Influenza
1%Rhinovirus infetion
1%B-cell lymphoma
1%Chronic obstructive pulmonary disease
1%Haemoptysis
1%Pulmonary hypertension
This histogram enumerates side effects from a completed 2019 Phase 2 & 3 trial (NCT02630316) in the Active Inhaled Treprostinil ARM group. Side effects include: Cough with 44%, Headache with 28%, Dyspnoea with 25%, Dizziness with 18%, Nausea with 15%.

Trial Design

2 Treatment Groups

Inhaled Treprostinil
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

396 Total Participants · 2 Treatment Groups

Primary Treatment: Inhaled Treprostinil · Has Placebo Group · Phase 3

Inhaled TreprostinilExperimental Group · 2 Interventions: Treprostinil Ultrasonic Nebulizer, Inhaled Treprostinil · Intervention Types: Device, Drug
PlaceboPlaceboComparator Group · 2 Interventions: Placebo, Treprostinil Ultrasonic Nebulizer · Intervention Types: Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treprostinil
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 52

Who is running the clinical trial?

United TherapeuticsLead Sponsor
105 Previous Clinical Trials
11,569 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient has been diagnosed with idiopathic pulmonary fibrosis (IPF) based on the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline, and the diagnosis has been confirmed by a review of their high-resolution computed tomography (HRCT) scan (performed within the previous 12 months)
Women who might become pregnant during the study must not be pregnant (confirmed by a urine pregnancy test), must not be breastfeeding, and must use two forms of contraception for the duration of the study and for at least 30 days after they stop taking the study drug.
If you are male and have a partner who could potentially become pregnant, you must use a condom for the duration of treatment and for at least 48 hours after discontinuing the study drug.
The Investigator believes that the subject is able to communicate effectively with study personnel and that they are reliable, willing, and cooperative with the study requirements.
The subject agrees to participate in the study and is aware of the risks and benefits involved.
The subject must be at least 40 years old when they sign the consent form.
The individual has a forced vital capacity (FVC) of at least 45% predicted at Screening.
People taking pirfenidone or nintedanib must have been on a stable and optimized dose for at least 30 days before the study begins

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: November 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas60.0%
Kansas20.0%
New Jersey20.0%
How old are they?
18 - 6550.0%
65+50.0%
What site did they apply to?
Northwell Health50.0%
Memorial Hermann-Texas Medical Center50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
0100.0%