A study published in The New England Journal of Medicine examined results from the phase 3 TETON-1 clinical trial of inhaled treprostinil for idiopathic pulmonary fibrosis (IPF).
IPF is a rare, progressive disorder characterized by the progressive scarring of tissues in the lungs. Common symptoms include shortness of breath and a dry, hacking cough. In some cases fibrosis happens quickly, while in others, the process is slower. The cause of IPF is unknown. It is most often diagnosed in patients aged 60 to 70 years.
In the double-blind TETON-1 (NCT04708782) study, 598 patients with IPF were randomly assigned to receive inhaled treprostinil or placebo. The primary end point was the change in forced vital capacity (FVC) at week 52.
A total of 434 patients completed the assessments through week 52. 77.6% were receiving background antifibrotic therapy and the percentage of predicted FVC at baseline was 74.6%. The median change in FVC at week 52 was −43.3 ml with treprostinil and −196.2 ml with placebo. Clinical worsening occurred in 31.8% of patients treated with treprostinil and in 44.5% with placebo. No significant difference was observed in the time to an IPF exacerbation, and no further inferences regarding secondary end points were made.
The most frequent adverse event was cough. Discontinuation of treprostinil or placebo occurred in 40.5% and 32.8% of the patients, respectively, with adverse events being the primary reason. Efficacy and safety outcomes were similar in analyses of the combined trial data.
To learn more about IPF and other rare lung conditions, visit https://checkrare.com/diseases/lung-diseases/