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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035407
Receipt No. R000040345
Scientific Title Effect of whole lung lavage (WLL) on exhaled nitric oxide fraction in patients with autoimmune pulmonary alveolar proteinosis (aPAP)
Date of disclosure of the study information 2018/12/29
Last modified on 2018/12/29

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Basic information
Public title Effect of whole lung lavage (WLL) on exhaled nitric oxide fraction in patients with autoimmune pulmonary alveolar proteinosis (aPAP)
Acronym Effect of WLL on exhaled nitric oxide fraction in patients with aPAP
Scientific Title Effect of whole lung lavage (WLL) on exhaled nitric oxide fraction in patients with autoimmune pulmonary alveolar proteinosis (aPAP)
Scientific Title:Acronym Effect of WLL on exhaled nitric oxide fraction in patients with aPAP
Region
Japan

Condition
Condition autoimmune pulmonary alveolar proteinosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the FeNO in patients with aPAP before and after the treatment with WLL
Basic objectives2 Others
Basic objectives -Others The comparison of the FeNO concentration with other paramters before and after the each lung lavage in the PAP patients.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The measurement of the FeNO concentration before and after the each lung lavage in the PAP patients.
Key secondary outcomes The comparison of the FeNO concentration with other paramters before and after the each lung lavage in the PAP patients.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 whole lung lavage (WLL) treatment
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria aPAP diagnosed according to standard diagnostic criteria with positive results of anti-GM-CSF antibody
Key exclusion criteria 1. Diagnosed as secondary or hereditary pulmonary alveolar proteinosis
2. History of malignant disease within recent 5 years
3. Complication of cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc with severe condition
4. Complication of respiratory diseases such as pulmonary infectious disease, bronchial asthma, lung fibrosis, interstitial pneumonitis, or bronchiectasis
5. History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks
6. Severe liver dysfunction
7. Severe renal dysfunction
8. Other patients judged to be inappropriate for the study by the attending physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Ichiwata
Organization Tokyo Medical University Hachioji Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 1163 Tate-machi, Hachioji-shi, Tokyo
TEL 042-665-5611
Email ichiwata@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinji teramoto,MD, PhD
Organization Tokyo Medical University Hachioji Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 1163 Tate-machi, Hachioji-shi, Tokyo
TEL 042-665-5611
Homepage URL
Email shinjit-tky@umin.ac.jp

Sponsor
Institute Tokyo Medical University Hachioji Medical Center
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東京医科大学八王子医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 29 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 10 Day
Last follow-up date
2020 Year 04 Month 01 Day
Date of closure to data entry
2021 Year 04 Month 01 Day
Date trial data considered complete
2021 Year 04 Month 01 Day
Date analysis concluded
2021 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2018 Year 12 Month 29 Day
Last modified on
2018 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040345

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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