UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000015508
Receipt No. 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 (Ver. 7)

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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
Last 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
Email sahomma@med.toho-u.ac.jp

Public contact
1st 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
Email susumu1029@med.toho-u.ac.jp

Sponsor
Institute Grant for Research on Diffuse Lung Disease from the Ministry of Health, Labour and Welfare of Japan.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018019