At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Placebo (drug), Inhaled Treprostinil (drug), Treprostinil Ultrasonic Nebulizer (device)
- How long the study runs
- Study runs about 49 months (dates as stated)
- About the drug or intervention
- Placebo — drug: Placebo administered QID · Inhaled Treprostinil — drug: Inhaled treprostinil (6 mcg/breath) administered QID · Treprostinil Ultrasonic Nebulizer — device: Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by United Therapeutics, is looking at whether an inhaled medicine called treprostinil is safe and helps people with progressive pulmonary fibrosis (a lung condition where scarring gets worse over time) that is not idiopathic pulmonary fibrosis. Progressive pulmonary fibrosis is a form of interstitial lung disease, a group of conditions causing inflammation and scarring in the lungs.
Who can take part
- Adults aged 18 or over who agree to take part
- Have scarring (fibrosis) on a lung scan (HRCT) in the past 12 months, covering more than 10% of the lung, checked by a central review team
- Have progressive pulmonary fibrosis that is not idiopathic pulmonary fibrosis (IPF), with signs of the disease getting worse in the past 2 years despite standard treatment. Worsening can include: a sizeable drop in breathing test results (10% or more), a smaller drop (5–10%) alongside worse breathlessness or more scarring on scans, or worse symptoms together with more scarring on scans
- Breathing test (FVC) result of at least 45% of the predicted value at screening, checked by central review
- Either taking nintedanib or pirfenidone for at least 90 days before the study starts and planning to carry on, or not taking either for at least 90 days and not planning to start. Taking both together is not allowed
- If taking medicines that dampen the immune system (such as mycophenolate, methotrexate, azathioprine, steroid tablets, or rituximab), must have been on them for at least 120 days and the treatment must not be working well, in the doctor's opinion
- Women who could become pregnant must not be pregnant or breastfeeding, and must either avoid sex or use two highly effective forms of contraception during the study and for 30 days after stopping the study medicine
- Men with a partner who could become pregnant must use a condom during treatment and for 48 hours after stopping
- Able to communicate with the study team and likely to attend all study visits
Who may not be able to
- Pregnant or breastfeeding
- Main problem is blocked airways rather than scarring (breathing test ratio below 0.70), or more emphysema than scarring on the lung scan
- A diagnosis of idiopathic pulmonary fibrosis (IPF)
- Previous bad reaction or no benefit from prostacyclin or similar medicines, leading to stopping or being unable to adjust the dose
- Taken any pulmonary hypertension (PAH) medicines — including prostacyclin-type medicines, selexipag, endothelin receptor antagonists, PDE5 inhibitors, or similar — in the 60 days before the study starts (PDE5 inhibitors for erectile dysfunction are allowed, but not within 48 hours before study tests)
- Needing more than 10 litres per minute of oxygen at rest
- A flare-up of lung disease or a chest or airway infection in the 30 days before the study starts (or hospital discharge for these within the past 90 days)
- Uncontrolled heart disease, such as a heart attack in the past 6 months or unstable angina in the past 30 days
- Taken part in another study with an experimental drug or device in the past 30 days (taking part in observational or registry studies is fine)
- A blood clot in the lungs (pulmonary embolism) in the past 90 days
- Any condition that, in the doctor's opinion, would interfere with study tests or taking part
- Life expectancy of less than 12 months, in the doctor's opinion
- Taken nerandomilast in the past 60 days
What taking part involves
- • An inhaled medicine called treprostinil, breathed in through a nebuliser (a device that turns medicine into a fine mist)
- • Not stated whether everyone gets the active medicine or some get a placebo (dummy) — ask the trial team
- • You keep taking your usual lung fibrosis medicine (nintedanib or pirfenidone) if you were already on it, but not both together
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 698
- Started
- 2023-10-30
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for progressive pulmonary fibrosis
- • Phase3 - 698 participants
- • Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with progressive pulmonary fibrosis
Where?
- • Birmingham - Birmingham Heartlands Hospital
- • Cambridge - Royal Papworth Hospital
- • Edinburgh - NHS Lothian, Royal INfirmary of Edingburgh
- • London - Guy's Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.
More detail
Study RIN-PF-305 is a Phase 3, multinational, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of inhaled treprostinil in subjects with PPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo. All subjects will initiate inhaled treprostinil or placebo at a dose of 3 breaths administered 4 times daily (QID) and will titrate to a target dosing regimen of 12 breaths QID. Study drug doses may be titrated up as tolerated, until the target dose or maximum clinically tolerated dose is achieved. Once eligible, 6 Treatment Period visits to the clinic will be required at Weeks 4, 8, 16, 28, 40, and 52. Efficacy assessments include spirometry (forced vital capacity \[FVC\]), time to clinical worsening, time to first acute exacerbation of interstitial lung disease (ILD), overall survival, King's Brief Interstitial Lung Disease (K-BILD) questionnaire, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration, supplemental oxygen use, and lung diffusion capacity (DLCO). Safety assessments include the development of adverse events (AEs)/serious adverse events (SAEs), vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters. Subjects who complete the Week 52 Visit may be offered the opportunity to enter an open-label extension (OLE) study after completing the final study visit.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Subject gives voluntary agreement to take part to participate in the study.
- ✓Subject is ≥18 years of age, inclusive, at the time of signing agreement to take part.
- ✓Subject has radiological evidence of lung fibrosis of \>10% extent on an HRCT scan in the previous 12 months...
- ✓Clinically significant decline in % predicted FVC based on ≥10% relative decline
- ✓Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory...
Who cannot take part
- ✗Subject is pregnant or lactating.
- ✗Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC \<0.70 at Screening) or...
- ✗Subject has a diagnosis of IPF.
- ✗Subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that...
- ✗Subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
See the full criteria
Where Is This Study? (6 UK sites)
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Royal Papworth Hospital
Cambridge CB2 0AY, United Kingdom
NHS Lothian, Royal INfirmary of Edingburgh
Edinburgh EH16 4SA, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
Manchester University NHS Foundation Trust, North Manchester General Hospital
Manchester M8 5RB, United Kingdom
NHS Tayside, Perth Royal Infirmary
Perth PH1 1NX, United Kingdom
How to Get in Touch
United Therapeutics Global Medical Information
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