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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

SAPPHIRE Trial Summary

This trial will test whether inhaled treprostinil is an effective and safe treatment for sarcoidosis-associated interstitial lung disease and pulmonary hypertension.

Eligible Conditions
  • Sarcoidosis
  • Pulmonary Hypertension
  • Interstitial Lung Disease

SAPPHIRE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PVR by Right heart catheterization (RHC)
mPAP by Right heart catheterization (RHC)
Secondary outcome measures
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%
Bronchitis
1%
Bronchopulmonary aspergillosis
1%
Chronic respiratory failure
1%
Sepsis
1%
Pulmonary hypertension
1%
Pneumothorax
1%
Pain in extremity
1%
Chronic obstructive pulmonary disease
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

SAPPHIRE 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
1,340 Previous Clinical Trials
715,695 Total Patients Enrolled
United TherapeuticsIndustry Sponsor
107 Previous Clinical Trials
13,377 Total Patients Enrolled
1 Trials studying Sarcoidosis
12 Patients Enrolled for Sarcoidosis
Ali Ataya, MDPrincipal InvestigatorUniversity of Florida

Media Library

Inhaled Treprostinil (Prostacyclin Analogue) Clinical Trial Eligibility Overview. Trial Name: NCT03814317 — Phase 2
Sarcoidosis Research Study Groups: Study Group
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

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
University of Florida, Division of Pulmonary and Critical Care Medicine
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension
2020. "Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03814317.
All > Stronger Than Sarcoidosis > Pulmonary Hypertension
~2 spots leftby Apr 2025
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