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)

The pulmonary disease research center0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年6月24日

适应症

试验速览

暂无简介。

•Willingness to participate in study and sign consent form.
•At least 18 years old
•Clinically determined to have developed BOS according to the pathology or National Institutes of Health (NIH) Graft Versus Host Disease Consensus guidelines,2014
•Must have a FEV1<70%
•Patient must be symptomatic with a NIH symptom score 1-3 and other restrictive disease, cryptogenic organizing pneumonia, heart disease, infections, anemia, external chest wall compression are excluded.
•Patient must be stable with maximum 1% difference in FEV1 in past three months and no changes has been made in immunosuppressants and inhalers.
•In past three months patient must apply inhaler corticosteroid and long act beta two agonist with good compliance and routinely.
•No changes in type and dose of immunosuppressants, due to extrapulmonary graft-versus host disease , in past three months.
•Application of short or long act anticholinergic inhalers is not an obstacle, if it has not been in past three months.
•Patient must be able to use Revolizer.
•Patient must have adherence for exact performance of study protocol, participation in visits and application of interventions.

•life expectancy less than 6 months at the time of enrollment as judged by the enrolling investigator
•Chronic oxygen therapy
•FEV1 = 20%
•History of Thoracic air leak syndrome
•Presence of active pulmonary infection
•Active malignancy
•Graft failure
•History of asthma or obstructive lung disease
•Smoking in past year
•Dependency to alcohol or drug
•Presence of uncontrolled psychiatric disease
•pregnancy or nursing
•Treatment with prednisone at >1 mg/kg/day (or equivalent steroid) on the enrollment evaluation
•Known history of intolerance or allergy to anticholinergic drug
•History of urinary retention due to prostate hyperplasia or bladder neck obstruction, history of narrow angle glaucoma, Creatinine clearance less than 30 ml/min.
•History of arrhythmia in last year with application of antiarrhythmic drugs, myocardial infarction in past six months and history of hospital admission due to heart failure in last year.
•Participation in an ongoing study.
•Any condition that, in the opinion of the enrolling investigator, would interfere with the subject’s ability to comply with the study requirements
•Inability to perform pulmonary function tests reliably in the opinion of the enrolling investigator.
•No compliance

发起方

The pulmonary disease research center