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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022048
Receipt No. R000025413
Scientific Title The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT
Date of disclosure of the study information 2016/04/25
Last modified on 2020/04/27

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Basic information
Public title The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT
Acronym Chiba AFO-01 study
Scientific Title The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT
Scientific Title:Acronym Chiba AFO-01 study
Region
Japan

Condition
Condition Air flow obstruction after allogeneic SCT
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in patinets with AFO after allogeneic SCT
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The prevention rate of decreasing respiratory function of the triplet combination treatment in AFO patinets
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients who diagnosed as AFO start the combination treatment, includind butesonid/formoterol fumarate, clarjthromycin, and monterkast, immediately. If feasible, continue the triplet combination therapy for one year after diagonosis of AFO.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key 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
Key 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Emiko
Middle name
Last name Sakaida
Organization Chiba University Hospital
Division name Department of Hematology
Zip code 2608677
Address 1-8-1, inohana, Chuo-ku, Chiba
TEL 043-222-7171
Email chiaki-nakaseko@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Emiko
Middle name
Last name Sakaida
Organization Chiba University Hospital
Division name Department of Hematology
Zip code 2608677
Address 1-8-1, inohana, Chuo-ku, Chiba
TEL 043-222-7171
Homepage URL
Email esakaida@faculty.chiba-u.jp

Sponsor
Institute Department of Hematology, Chiba University Hospital
Institute
Department

Funding Source
Organization Department of Hematology, Chiba University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University Hospital
Address 1-8-1, inohana, Chuo-ku, Chiba
Tel 043-222-7171
Email esakaida@faculty.chiba-u.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学病院、青葉病院、成田赤十字病院、旭中央病院

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 85
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 01 Month 28 Day
Date of IRB
2016 Year 06 Month 19 Day
Anticipated trial start date
2016 Year 06 Month 20 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2021 Year 08 Month 31 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 25 Day
Last modified on
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025413

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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