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Prostacyclin Analogue

Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis (TETON Trial)

Phase 3

Recruiting

Research Sponsored by United Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for ≥30 days prior to Baseline. Concomitant use of both pirfenidone and nintedanib is not permitted.

Subject is ≥40 years of age, inclusive, at the time of signing informed consent.

Must not have

The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.

Use of any of the following medications: azathioprine (AZA), cyclosporine, mycophenolate mofetil, tacrolimus, oral corticosteroids (OCS) >20 mg/day or the combination of OCS+AZA+N-acetylcysteine within 30 days prior to Baseline; cyclophosphamide within 60 days prior to Baseline; or rituximab within 6 months prior to Baseline.

Timeline

Screening 3 weeks

Treatment 12 months

Follow Up week 52

Awards & highlights

Pivotal Trial

Summary

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

Who is the study for?

Adults over 40 with Idiopathic Pulmonary Fibrosis (IPF) confirmed by HRCT, having an FVC ≥45% predicted. They must not be pregnant or breastfeeding and agree to use contraception. Participants can't have severe obstructive airway disease, recent heart attacks, uncontrolled cardiac disease, or have used certain IPF treatments recently.

What is being tested?

The trial is testing inhaled treprostinil delivered via a nebulizer against a placebo to see if it improves lung function measured by forced vital capacity (FVC) after one year of treatment in patients with IPF.

What are the potential side effects?

While the side effects for this specific inhalation form are not detailed here, treprostinil can generally cause coughing, headaches, dizziness, nausea, flushing and jaw pain. The severity of these side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a stable dose of either pirfenidone or nintedanib for over 30 days, but not both.

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I am 40 years old or older.

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I have been on a stable dose of either pirfenidone or nintedanib for over 30 days, but not both.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a bad reaction or no improvement with a specific heart or lung treatment, leading to its discontinuation.

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I haven't taken specific immune system medications recently.

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I need more than 10 liters per minute of oxygen to breathe normally when resting.

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My doctor expects I have less than 6 months to live due to my lung condition or another illness.

Timeline

Screening ~ 3 weeks1 visit

Treatment ~ 12 months8 visits

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ 12 months

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, 12 months for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Absolute FVC from Baseline to Week 52

Secondary study objectives

Change in % Predicted FVC from Baseline to Week 52

Change in DLCO from Baseline to Week 52

Change in K-BILD Questionnaire Score from Baseline to Week 52

+3 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

Chest pain

Oedema peripheral

Upper respiratory tract infection

N-terminal prohormone brain natriuretic peptide increased

Epistaxis

Chest discomfort

Fall

Rhinorrhoea

Decreased appetite

Acute respiratory failure

Interstitial lung disease

Death

Pulmonary hypertension

Sepsis

Pain in extremity

Chronic obstructive pulmonary disease

Chronic respiratory failure

Pneumothorax

Bronchitis

Bronchopulmonary aspergillosis

Rhinovirus infetion

Cellulitis

Cardiopulmonary failure

Cor pulmonale

Left ventricular failure

Right ventricular failure

Tachycardia

Bradycardia

Influenza

Pneumonia

Hyperglycaemia

Hypervolaemia

B-cell lymphoma

Cerebral haemorrhage

Syncope

Respiratory failure

Combined pulmonary fibrosis and emphysema

Haemoptysis

Hypoxia

Idiopathic pulmonary fibrosis

Acute myocardial infarction

Acute right ventricular failure

Arrythmia

Cardiac arrest

Cardiac failure congestive

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Active Inhaled Treprostinil

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Inhaled TreprostinilExperimental Treatment2 Interventions

Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled QID and titrated up to a target of 12 breaths QID or until the subject reaches their maximum clinically tolerated dose.

Group II: PlaceboPlacebo Group2 Interventions

Matching placebo inhaled using an ultrasonic nebulizer QID

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inhaled Treprostinil

2017

Completed Phase 3

~330

0 / 7Eligibility criteria met