UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035407 |
|---|---|
| Receipt number | 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 | 2020/08/04 22:37:27 |
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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 | Toshio |
| Middle name | |
| Last name | Ichiwata |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Respiratory Medicine
Zip code
193-0998
Address
1163 Tate-machi, Hachioji-shi, Tokyo
TEL
+81426655611
shinjit-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Teramoto |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Respiratory Medicine
Zip code
193-0998
Address
1163 Tate-machi, Hachioji-shi, Tokyo
TEL
042-665-5611
Homepage URL
shinjit-tky@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hachioji Medical Center
Institute
Department
Personal name
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
Tokyo Medical University Hachioji Medical Center
Address
1163 Tatemachi Hachioji-shi Tokyo
Tel
+81426655611
shinjit-tky@umin.ac.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
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
| 2019 | Year | 12 | Month | 10 | Day |
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
| 2020 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040345
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