Study 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
Treatment Effectiveness
Phase-Based Effectiveness
Phase 2
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: Baseline, Week 8, Week 16
Baseline, Week 16
Change in Brain Natriuretic Peptide (BNP)
Change in Cardiac MRI parameters
Change in Pulmonary Function Testing
PVR by Right heart catheterization (RHC)
mPAP by Right heart catheterization (RHC)
Week 16
Change in 6-Minute Walk Test (6MWT)
Change in WHO Functional Class (WHO FC)
Trial Safety
Phase-Based Safety
This is further along than 68% 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%Chest discomfort
5%Fall
5%Rhinorrhoea
4%Decreased appetite
2%Interstitial lung disease
2%Death
2%Acute respiratory failure
1%Arrythmia
1%Cardiac failure congestive
1%Cardiopulmonary failure
1%Left ventricular failure
1%Right ventricular failure
1%Tachycardia
1%Pneumonia
1%Sepsis
1%Hyperglycaemia
1%Hypervolaemia
1%Pain in extremity
1%Cerebral haemorrhage
1%Syncope
1%Chronic respiratory failure
1%Respiratory failure
1%Combined pulmonary fibrosis and emphysema
1%Hypoxia
1%Idiopathic pulmonary fibrosis
1%Pneumothorax
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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Study Group
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: Inhaled Treprostinil · No Placebo Group · Phase 2
Study Group
Drug
Experimental Group · 1 Intervention: Inhaled Treprostinil · Intervention Types: DrugTreatment
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: baseline, week 8, week 16
Who is running the clinical trial?
University of FloridaLead Sponsor
1,274 Previous Clinical Trials
700,077 Total Patients Enrolled
United TherapeuticsIndustry Sponsor
106 Previous Clinical Trials
12,254 Total Patients Enrolled
1 Trials studying Sarcoidosis
12 Patients Enrolled for Sarcoidosis
Ali Ataya, MDPrincipal InvestigatorUniversity of Florida
Eligibility Criteria
Age 18 - 99 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Georgia | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Florida, Division of Pulmonary and Critical Care Medicine | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |