Bronchiolitis obliterans. Other specified interstitial pulmonary diseases
Conditions
Interventions
Intervention 1: Intervention group1: During the treatment period A, patients will receive inhaled Tiotropium Bromide (KP-Tiova Rotacaps 18 mcg
Cipla
India) at a dose of 18 micrograms once daily in the morning for one month using a dry powder for inhaler device (Dry Powder Inhaler: DPI) (Revolizer
India) plus usual standard care. Intervention 2: Intervention group2: During the treatment period B, patients will receive Tiotropium Bromide Placebo Revolizer plus standard usual care. After the comp
Sponsors
The pulmonary disease research center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Forced Expiratory Volume in one second. Timepoint: Before starting the study in each period,25 to30 days after each period. Method of measurement: Spirometry.;Forced Vital Capacity. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measurement: Spirometry.;Peak Expiratory Flow Rate. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measurement: Spirometry.;Airway resistance at 5Hz. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measurement: Impulse Oscillometry.;Airway resistance at 20Hz. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measurement: Impulse Oscillometry.;Difference in airway resistance at 20Hz and 5Hz. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measurement: Impulse Oscillometry.;Airway reactance at 5Hz. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measurement: Impulse Oscillometry.;Area of airway reactance. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measurement: Impulse Oscillometry.;Airway impedance at 5Hz. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measurement: Impulse Oscillometry.;Resonant Frequency. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measurement: Impulse Oscillometry.;NIH Lung Symptom Score. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measurement: Questionnaire.;Six minute walk test distance. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measurement: Six minute walk test.;36-Item Short Form Survey score. Timepoint: Before starting the study in each period,25 to 30 days after each period. Method of measure | — |
Primary
| Measure | Time frame |
|---|---|
| Forced Expiratory Volume in one second. Timepoint: Before starting the study,25 to 30 days after each period. Method of measurement: Spirometry. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRasoul Aliannejad
Tehran University of Medical Sciences
Outcome results
None listed