UMIN-CTR Clinical Trial

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
Email	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
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	Tokyo Medical University Hachioji Medical Center
Address	1163 Tatemachi Hachioji-shi Tokyo
Tel	+81426655611
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040345