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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007663
Receipt No. R000008999
Scientific Title Efficacy of inhaled N-acetylcysteine(NAC) on lung function and redox balance in idiopathic pulmonary fibrosis(IPF).
Date of disclosure of the study information 2012/04/05
Last modified on 2012/04/04

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Basic information
Public title Efficacy of inhaled N-acetylcysteine(NAC) on lung function and redox balance in idiopathic pulmonary fibrosis(IPF).
Acronym Efficacy of inhaled NAC in IPF.
Scientific Title Efficacy of inhaled N-acetylcysteine(NAC) on lung function and redox balance in idiopathic pulmonary fibrosis(IPF).
Scientific Title:Acronym Efficacy of inhaled NAC in IPF.
Region
Japan

Condition
Condition Idiopathic pulmonary fibrosis
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of inhaled N-acetylcysteine(NAC) mono-therapy on lung function and redox balance.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes in respiratory function test before and after the therapy.
Key secondary outcomes The levels of total GSH(tGSH), oxidized GSH(GSSG), and GSH/GSSG ratio in the peripheral blood, and 8-OHdG in the urine.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 inhaled NAC mono-therapy
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)From 50 to 80 years-old
2)Patients with informed consent
3)The patients who have never treated.
4)The patients with stage I or stage II disease severity according to the Japanese Respiratory Society criteria.
Key exclusion criteria 1)Secondary interstitial pneumonia
2)Serious complication
3)Serious drug allergy
4)Mental disorder, central nervous system disorders, cerebrovascular disorders
5)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoko Muramatsu
Organization Toho University Omori Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Muramatsu
Organization Toho University Omori Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Toho University Omori Medical Center
Department of Respiratory Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 05 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 Open public recruiting
Date of protocol fixation
2009 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 04 Day
Last modified on
2012 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008999

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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