Exclusion criteria | Inclusion criteria |
---|---|
1) Life expectancy < 6 months at the time of enrollment as judged by the enrolling investigator | 1) Subjects able to sign the Informed Consent |
2) The need for chronic oxygen therapy | 2) 18 years of age or older |
3) Baseline %FEV1 ≤ 20% | 3) Diagnosis of post-HSCT-BOS according to NIH 2014 criteria |
4) History of thoracic air leak syndrome | 4) Baseline %FEV1 < 70% |
5) Documented respiratory infection | 5) Must be symptomatic, defined as NIH Lung Score 1–3, and no other contributing etiology (including cardiac diseases, infection, anemia, or extrinsic thoracic compression) is present for respiratory symptoms |
6) Active malignancy | 6) Stable disease defined as less than 10% change in %FEV1 during the past 3 months while having no change in immunosuppressive and topical respiratory medications in the past 3 months |
7) Graft failure | 7) Must have received a combination of inhaled corticosteroid and inhaled long-acting beta-2 agonist during the past 3 months |
8) Known history of asthma or chronic obstructive lung disease (COPD) | 8) No new or supplemental immunosuppressive therapy for extra-thoracic GVHD during the past 3 months |
9) Active smoking during the past 12 months | 9) Patients with prior exposure to short-acting or long-acting inhaled anti-cholinergic drugs are eligible unless they have been received within the past 3 months |
10) Substance abuse or uncontrolled psychiatric disorder | 10) Ability to use Revolizer |
11) Pregnant or nursing women | |
12) Daily corticosteroid of more than 1 mg/kg prednisone equivalent | |
13) Known intolerance or allergy to anticholinergic drugs | |
14) History of urinary retention, angle-closure glaucoma, CrCl ≤ 30 ml/min | |
15) History of arrhythmia in past years, MI in past 6 months, or hospital admission due to heart failure in past year | |
16) Ongoing participation in any other clinical trial (more typical would be using an investigational agent within 28 days of enrollment) | |
17) Any condition that, in the opinion of the enrolling investigator, would interfere with the subject's ability to comply with the study requirements | |
18) Inability to perform pulmonary function tests (PFT) reliably, as determined by the enrolling investigator or PFT lab | |
19) No compliance |