UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2009 Year 05 Month 29 Day
Date of IRB	2009 Year 05 Month 29 Day
Anticipated trial start date	2009 Year 06 Month 01 Day
Last follow-up date	2012 Year 10 Month 31 Day
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	2021 Year 06 Month 30 Day

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