A placebo-controlled, crossover trial to investigate the efficacy of Tiotropium Bromide or Placebo added to usual care in stable symptomatic post-Hematopoietic Stem Cell Transplantation (HSCT) Bronchiolitis Obliterans Syndrome (BOS)

Abstract

Abstract Background: Despite the fundamental progress in Hematopoietic stem cell transplant, this treatment is also associated with complications. Graft versus Host Disease is a possible complication of HSCT. Bronchiolitis obliterans syndrome (BOS) is the pulmonary form of this syndrome. Due to the high morbidity and morbidity rate of BOS, various studies have been conducted in the field of drug therapy for this syndrome, although no standard treatment has yet been proposed. According to the hypotheses about the similarities between BOS and chronic obstructive pulmonary disease, the idea of using tiotropium bromide as a bronchodilator has been proposed. Method/design: A randomized, double-blind, placebo-controlled, and crossover clinical trial is being conducted to evaluate the efficacy of tiotropium in patients with BOS. A total of 20 patients with BOS, were randomly assigned (1:1) to receive a once-daily inhaled capsule of either Tiotropium bromide (KP-Tiova Rotacaps 18 mcg; Cipla; India) or placebo for 1 month. Patients will receive Tiotropium Bromide or placebo Revolizer added to usual standard care. Measurements will include spirometry, six-minute walking test. Ethics/dissemination: This study was approved by the Research Ethics Committees of Imam Khomeini Hospital Complex, Tehran University of Medical science. Recruitment started in September 2022, with 20 patients randomized. The treatment follow-up of participants with Tiotropium is currently ongoing and is due to finish in December 2023. The authors will disseminate the findings in peer-reviewed publications, conferences and seminar presentations. Trial registration: Iranian registry of clinical trial IRCT registration number: IRCT20200415047080N3 Registration date: 2022-07-12, 1401/04/21