56
Participants
Start Date
May 1, 2024
Primary Completion Date
May 31, 2026
Study Completion Date
December 31, 2026
budesonide
During an 8-week treatment period, patients will receive 9 mg of Budesonide daily, administered orally in enteric-coated capsules. Following this period, participants will undergo a gradual dose reduction to minimize the risk of adrenal insufficiency: 6 mg daily for 2 weeks, followed by 3 mg daily for another 2 weeks before discontinuing treatment.
Mannitol
During an 8-week treatment period, patients will receive 9 mg of Mannitol daily, administered orally in enteric-coated capsules as placebo control. Following this period, participants will undergo a gradual dose reduction as is the case in the experimental group: 6 mg daily for 2 weeks, followed by 3 mg daily for another 2 weeks before discontinuing treatment.
RECRUITING
UZ Leuven, Leuven
Universitaire Ziekenhuizen KU Leuven
OTHER