UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007663 |
|---|---|
| Receipt number | 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 | 2021/06/30 15:59:28 |
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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
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
Sponsor or person
Institute
Toho University Omori Medical Center
Department of Respiratory Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008999
