A new randomized controlled clinical trial (EXAFIP2) aiming to assess the efficacy of glucocorticoids during acute exacerbations of idiopathic pulmonary fibrosis (IPF) will begin in March 2023.
The study will enroll 110 adults with IPF or suspected IPF who present with definite or suspected acute exacerbation. Participants randomized to the glucocorticoids group will receive 10 mg/kg/d of intravenous methylprednisolone from day 1 to day 3 and oral prednisone slowly tapered from day 4 to day 30.
The primary outcome measure of the trial is the efficacy of glucocorticoids compared to that of placebo in terms of mortality, corresponding to the all-cause mortality rate at day 30.
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Secondary outcome measures include: time to death at day 30 and day 90, death or transplantation at day 90, respiratory disease-specific mortality rate at day 30 and day 90, time to worsening, percentage of patients admitted to the intensive care unit, percentage of patients requiring invasive ventilation, length of hospital stay, radiological evolution, pulmonary function test evolution (forced vital capacity and diffusing capacity of the lungs for carbon monoxide), and the occurrence of infectious disease, diabetes, cardiovascular disorder, neuropsychological disturbances, and clinical laboratory evaluation.
Furthermore, investigators will compare the treatment and placebo arms in terms of anxiety, depression, and clinical status at day 15.
The study’s exclusion criteria include an identified etiology for acute worsening, a known hypersensitivity to glucocorticoids or any other component of the study treatment, active infection or cancer, pregnancy or lactation, a requirement for mechanical ventilation, and treatment with glucocorticoids (>1 mg/kg/d) for more than 7 days in the 15 days prior to enrollment. It will also exclude patients who are on a lung transplantation waiting list, enrolled in another interventional clinical trial, deprived of liberty, or under tutorship, curatorship, or court protection.
The sponsor of EXAFIP2, Groupe Hospitalier Paris Saint Joseph, estimates that the study will be completed by the end of 2025.
Glucocorticoids versus placebo for the treatment of acute exacerbation of idiopathic pulmonary fibrosis (EXAFIP2). ClinicalTrials.gov. January 9, 2023. Updated January 13, 2023. Accessed January 20, 2023.