UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016706 |
|---|---|
| Receipt number | R000019377 |
| Scientific Title | Efficacy and safety of inhaled N-acetylcysteine in idiopathic pulmonary fibrosis |
| Date of disclosure of the study information | 2015/03/04 |
| Last modified on | 2016/03/09 11:53:06 |
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Basic information
Public title
Efficacy and safety of inhaled N-acetylcysteine in idiopathic pulmonary fibrosis
Acronym
Efficacy of inhaled N-acetylcysteine in IPF
Scientific Title
Efficacy and safety of inhaled N-acetylcysteine in idiopathic pulmonary fibrosis
Scientific Title:Acronym
Efficacy of inhaled N-acetylcysteine in IPF
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety in patients with IPF who treated with inhaled N-acetylcysteine therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An absolute change in FVC at week 26 after the initiation of N-acetylcysteine therapy.
Key secondary outcomes
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
N-acetylcysteine was administered by inhalation at the dose of 352.4 mg b.i.d. via an ultrasonic nebulizer.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The diagnosis of IPF and inclusion of subjects in the present study were based on the following criteria: an usual interstitial pneumonia (UIP) pattern or possible UIP pattern on high-resolution CT in accordance with the 2011 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American thoracic Association official statement on IPF.
Key exclusion criteria
The exclusion of other clinically known causes of UIP such as drug-induced pneumonitis, collagen vascular diseases, and hypersensitivity pneumonitis.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryo Okuda |
Organization
Saitama Red Cross Hospital
Division name
Respiratory medicine
Zip code
Address
8-3-33 Kami-ochiai, Chuo-ku, Saitama, Japan
TEL
048-852-1111
b980013@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Okuda |
Organization
Saitama Red Cross Hospital
Division name
Respiratory medicine
Zip code
Address
8-3-33 Kami-ochiai, Chuo-ku, Saitama, Japan
TEL
048-852-1111
Homepage URL
b980013@yahoo.co.jp
Sponsor or person
Institute
Saitama Red Cross Hospital
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
| 2015 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | 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
| 2015 | Year | 03 | Month | 04 | Day |
Last modified on
| 2016 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019377
