The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT

Not Applicable

• Conditions: Air flow obstruction after allogeneic SCT

• Registration Number: JPRN-UMIN000022048
• Lead Sponsor: Department of Hematology, Chiba University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-25
• Study Completion: 2021-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

1. Known history of intolerance or allergy to any triplet component. 2. The patient who has past history of asthma and had attack within one year. 3. The patient who has already been treated with the triplet combination. 4. The patient who has active infection 5. The patient who has mental disability requiring treatment 6. The patient who has severe thromboembolism, including myocardial infarction, cerebral infarction, and cardiovascular complications. 7. The patient who has uncontrollable diabetes mellitus and metabolic disease 8. The patient who has other malignancy requiring anticancer treatment 9. Pregnancy or nursing. 10. At the time of enrollment as judged by the enrolling investigator would interfere with the subjects ability to comply with the study requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevention rate of decreasing respiratory function of the triplet combination treatment in AFO patinets

Secondary Outcome Measures

Name	Time	Method
Efficacy: 1) incidence of AFO in allogeneic stem cell ytansplant recipients 2) the rate of symptom improvement after intervention with triplet combination therapy 3) the rate of the detection of radiologic abnormality, and improvement 4) the correlation between the occurrence of AFO and chronic GVHD 5) OS, NRM, relapse rate 6) the rate of intervention of immunosuppressant 7) QOL assessment by CATS scoring Safety: 1) adverse events dueing the treatment 2) incidence of infectious episode