TETON-2
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (TETON-2)
IRAS ID
1005725
Contact name
Amin Boateng
Contact email
Sponsor organisation
UNITED THERAPEUTICS CORPORATION
Eudract number
2021-005881-17
Clinicaltrials.gov Identifier
Research summary
Currently there is no cure for idiopathic pulmonary fibrosis (IPF), and only 2 drugs are approved to treat the condition (nintedanib and pirfenidone).
Patients with IPF have scarring of the lungs from an unknown cause that makes it difficult for the lungs to get oxygen into the blood, which causes shortness of breath and coughing.
Inhaled treprostinil is an investigational drug being developed by United Therapeutics Corporation which may offer a treatment option for patients with IPF.
Treprostinil is given by inhaling (breathing in) the medicine into the lungs using a TD-300/A inhalation device called a nebuliser (inhaling device). The nebuliser changes the medicine into a mist to breathe into the lungs.
This study is investigating whether inhaled treprostinil works to help people with idiopathic pulmonary fibrosis (IPF) improve their lung function and if they are able to administer treprostinil on their own with the TD 300/A inhalation device.
Approximately 396 adults over 40 years of age with IPF will take part in this study across 100 study sites worldwide. Participants will be in the study for about 58 weeks with approximately 8 visits to the study site.
Participants will be randomly assigned to receive either inhaled treprostinil or placebo (which looks exactly like inhaled treprostinil but does not contain the active ingredient) for the whole study to be inhaled 4 times a day during waking hours.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0002
Date of REC Opinion
5 Apr 2023
REC opinion
Further Information Unfavourable Opinion