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Prostacyclin Analogue

Inhaled Treprostinil for Sarcoidosis (SAPPHIRE Trial)

Phase 2
Recruiting
Led By Ali Ataya, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8, week 16
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing an inhaled medication called treprostinil for people with a specific lung disease (sarcoidosis) that causes high blood pressure in the lungs. The treatment aims to help these patients breathe better and exercise more easily by widening their lung blood vessels. The study will also check if this treatment is safe for them. Inhaled treprostinil has been shown to improve exercise tolerance and has demonstrated safety and beneficial effects on hemodynamics, exercise capacity, and quality of life.

Who is the study for?
This trial is for adults with sarcoidosis-associated lung disease and high blood pressure in the lungs. Participants must be able to walk a certain distance, not be pregnant or breastfeeding, have stable health conditions, and agree to use birth control if applicable. Those on certain heart medications or with severe heart issues cannot join.
What is being tested?
The study tests the effectiveness and safety of inhaling Treprostinil—a medication—in patients who have both sarcoidosis-related lung scarring and pulmonary hypertension (high blood pressure affecting the lungs).
What are the potential side effects?
Inhaled Treprostinil may cause coughing, headaches, nausea, dizziness, flushing, throat irritation or pain. It can also increase the risk of bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8, week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8, week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PVR by Right heart catheterization (RHC)
mPAP by Right heart catheterization (RHC)
Secondary study objectives
Change in 6-Minute Walk Test (6MWT)
Change in Brain Natriuretic Peptide (BNP)
Change in Cardiac MRI parameters
+2 more

Side effects data

From 2019 Phase 2 & 3 trial • 326 Patients • NCT02630316
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%
N-terminal prohormone brain natriuretic peptide increased
6%
Epistaxis
5%
Chest discomfort
5%
Fall
5%
Rhinorrhoea
4%
Decreased appetite
2%
Acute respiratory failure
2%
Interstitial lung disease
2%
Death
1%
Pulmonary hypertension
1%
Sepsis
1%
Pain in extremity
1%
Chronic obstructive pulmonary disease
1%
Chronic respiratory failure
1%
Pneumothorax
1%
Bronchitis
1%
Bronchopulmonary aspergillosis
1%
Rhinovirus infetion
1%
Cellulitis
1%
Cardiopulmonary failure
1%
Cor pulmonale
1%
Left ventricular failure
1%
Right ventricular failure
1%
Tachycardia
1%
Bradycardia
1%
Influenza
1%
Pneumonia
1%
Hyperglycaemia
1%
Hypervolaemia
1%
B-cell lymphoma
1%
Cerebral haemorrhage
1%
Syncope
1%
Respiratory failure
1%
Combined pulmonary fibrosis and emphysema
1%
Haemoptysis
1%
Hypoxia
1%
Idiopathic pulmonary fibrosis
1%
Acute myocardial infarction
1%
Acute right ventricular failure
1%
Arrythmia
1%
Cardiac arrest
1%
Cardiac failure congestive
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Active Inhaled Treprostinil

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study GroupExperimental Treatment1 Intervention
Sarcoidosis patients with interstitial lung disease and precapillary pulmonary hypertension based on right heart catheterization (RHC). All subjects will initiate inhaled treprostinil at a dose of 3 breaths (18 mcg) four times daily. Study drug doses escalations (additional one breath four times daily) can occur every three days with a maximum dosing regimen of up to 12 breaths (72 mcg) four times daily, as clinically tolerated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inhaled Treprostinil
2017
Completed Phase 3
~330

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,393 Previous Clinical Trials
767,014 Total Patients Enrolled
United TherapeuticsIndustry Sponsor
110 Previous Clinical Trials
14,516 Total Patients Enrolled
Ali Ataya, MDPrincipal InvestigatorUniversity of Florida

Media Library

Inhaled Treprostinil (Prostacyclin Analogue) Clinical Trial Eligibility Overview. Trial Name: NCT03814317 — Phase 2
Cardiac Sarcoidosis Research Study Groups: Study Group
Cardiac Sarcoidosis Clinical Trial 2023: Inhaled Treprostinil Highlights & Side Effects. Trial Name: NCT03814317 — Phase 2
Inhaled Treprostinil (Prostacyclin Analogue) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03814317 — Phase 2
~0 spots leftby Jan 2025
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