A new clinical trial that aims to assess the efficacy of an investigational therapy for idiopathic pulmonary fibrosis (IPF) recently opened.

The phase 2 participant- and investigator-blinded, randomized, placebo-controlled, multicenter study will include 94 patients with a diagnosis of IPF based on the American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) IPF 2018 modified guidelines. Researchers believe that none of the participants are likely to undergo a lung transplant during the span of the study.

All patients will have a forced vital capacity (FVC) over 45% of predicted and a diffusing capacity for carbon monoxide (DLCO) over 25% of predicted. All patients included in the study must be at least 40 years of age. Patients with evidence of airway obstruction, bronchodilator response, connective tissue disease, emphysema, or a history of IPF exacerbation in the last 3 months will be excluded from the study.


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Patients will be divided into 2 groups. One group will receive the experimental treatment, called LTP001, orally once a day for 26 weeks; the placebo group will receive a placebo pill for an equal amount of time. Primary and secondary outcome measures will be measured at weeks 4, 8, 12, 16, 20, and 26.

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The primary outcome measure will be the change in FVC from baseline until the end of treatment. Secondary outcome measures will include the change in DLCO from baseline, change in 6-minute walk distance from baseline, changes in scores from standardized IPF questionnaires, number of participants with an absolute decline in FVC of greater than 10%, and time to progression.

The study is estimated to start in the first week of October 2022 and should be completed by February 2025.

Currently, antifibrotic drugs such as pirfenidone and nintedanib constitute the mainstay of treatment for IPF due to their ability to slow the decrease in FVC.

The benefits of other available pharmacological treatments, such as morphine, thalidomide, and oral corticosteroids, are not well established. The median survival rate of IPF after diagnosis is approximately 3 to 5 years without treatment.

Reference

To assess the efficacy of the investigational products compared to placebo in participants with IPF. ClinicalTrials.gov. August 11, 2022. Accessed August 31, 2022.