UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015508 |
|---|---|
| Receipt number | R000018019 |
| Scientific Title | A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. |
| Date of disclosure of the study information | 2014/10/24 |
| Last modified on | 2019/04/30 08:47:58 |
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Basic information
Public title
A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.
Acronym
Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.
Scientific Title
A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.
Scientific Title:Acronym
Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine compared with pirfenidone alone for idiopathic pulmonary fibrosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in forced vital capacity
Key secondary outcomes
(1)Changes in distance and lowest SpO2 in 6-minute walk test,
(2)Changes in vital capacity(VC), %VC, total lung capacity(TLC), %TLC, diffusion capacity of the lung for carbon monoxide (DLco), %DLco. A category analysis of FVC (5% or greater decline or decline less than 5% in FVC)
(3) Changes in serum maker (KL-6, SP-D, SP-A)
(4) Changes in high-resolution computed tomography (HRCT) findings
(5) Changes in dyspnea (mMRC)
(6) Changes in health Health-related Quality of Life (CAT score)
(7) Safety
(8) Incidence of acute exacerbation
(9) Progression-free survival time
(10) Survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Using Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which was diluted with saline to a total volume of 6 mL for 48 weeks.
Interventions/Control_2
Pirfenidone 1200-1800mg (control group)
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
patients diagnosed as IPF/UIP according to ATS/ERS/JRS/ALAT guidline.
(1)age:>=40years
(2)sex:male or female
(3)patient who intiate pirfenidone or under treatment with pirfenidone.
(4)%FVC >= 50%, %DLco>= 35%, FEV1% > 70%
(5)all patients must provide written informed consent
(6)patient who did not have a treatment with inhaled NAC in previous 3 months.
Key exclusion criteria
1.coexisting severe cardiovascular disease
2.coexisting severe liver disfunction
3.coexisting chronic kidney disease
4.patients who had a history of receiving chemotherapy or thoracic radiotherapy
5.patients who are pregnant or possibly pregnant, or nursing
6.patients who were unable to undergo physiologic tests
7.candidates for lung transplantation
8.improving physiologic tests or HRCT findings compared with previous 6 months.
9.patient who were administered with 20 mg/day or more of predonisolone during the preceding 3 months. Treated with NAC or nintedanib during the preceding 3 months.
10.treated with immunosuppressive agents.
11.coexisting pulmonary arterial hypertension, bronchial asthma,sarcoidosis,bronchiectasis, neoplasm,infectious disease.
12.patients who participated in another clinical study within 3 months prior to the administration period of the study drug.
13.considered ineligible for the study by the investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | homma |
| Middle name | |
| Last name | sakae |
Organization
Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo,
Japan.
Division name
Department of Respiratory Medicine
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo,
TEL
03-3762-4151
sahomma@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Sakamoto |
Organization
Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo,
Division name
Department of Respiratory Medicine
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo,
TEL
03-3762-4151
Homepage URL
susumu1029@med.toho-u.ac.jp
Sponsor or person
Institute
Grant for Research on Diffuse Lung Disease from the Ministry of Health, Labour and Welfare of Japan.
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho university omori medical center
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo,
Tel
0337624151
somu.omori@jim.toho-u.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 24 | Day |
Related information
URL releasing protocol
UMIN000015508
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
81
Results
There was no difference between the two groups in the of change in FVC.
Results date posted
| 2019 | Year | 04 | Month | 30 | Day |
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
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 02 | Month | 26 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 23 | Day |
Last modified on
| 2019 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018019
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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