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

The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT - Chiba AFO-01 study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022048
Enrollment
60
Registered
2016-04-25
Start date
2016-06-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Air flow obstruction after allogeneic SCT

Interventions

The patients who diagnosed as AFO start the combination treatment, includind butesonid/formoterol fumarate, clarjthromycin, and monterkast, immediately. If feasible, continue the triplet combination t

Sponsors

Department of Hematology, Chiba University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patient who receive the 1st allogeneic stem cell transplantation 2. The patient who can examine the pulmonary function tests. 3. PS (ECOG), 0-2 4. The patient who has no exceptionable organ problems 1) serum ALT/AST concentrations:150 IU/L and under 2) total bilirubin: 3mg/dL and under 3) CCr:40ml/min or over (by C-G) 4) arterial blood oxygen saturation or SpO2 in room air:94% or over 5. Written informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The prevention rate of decreasing respiratory function of the triplet combination treatment in AFO patinets

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactEmiko Sakaida

Chiba University Hospital Department of Hematology

esakaida@faculty.chiba-u.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026