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)

Not Applicable

Conditions: Bronchiolitis obliterans.
Other specified interstitial pulmonary diseases
J84.89

Registration Number: IRCT20200415047080N3

Lead Sponsor: The pulmonary disease research center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 24

Inclusion Criteria

Willingness to participate in study and sign consent form.
Both sexes
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.

Exclusion Criteria

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