UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016045
Receipt number R000018649
Scientific Title A case-control study 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 2014/12/26
Last modified on 2019/04/30 09:35:33

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A case-control study 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 case-control study 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

Progression-free survival time
Incidence of acute exacerbation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



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

20 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. Stage III or IV according to JRS criteria.
(1)adult
(2)sex:male or female
(3)patient who had declines in FVC of 10% or more during the 6 months before the study.
(4)all patients must provide written informed consent

Key exclusion criteria

The exclusion criteria were
(1) clinical features of idiopathic interstitial pneumonia other than IPF,
(2) duration of pirfenidone therapy shorter than 1 month, due to adverse events,
(3) poor adherence to inhaled NAC therapy,
(4) an extent of emphysema greater than that of fibrotic change on HRCT, or physiological evidence of airflow obstruction, defined as a ratio of forced expiratory volume in 1 second (FEV1) to FVC of <0.7 or a residual volume >120%, and
(5) evidence of coexisting respiratory infection or lung cancer

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Sakae
Middle name
Last name Homma

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

Email

susumu1029@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


Email

susumu1029@med.toho-u.ac.jp


Sponsor or person

Institute

Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo,

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

Toho university omori medical center

Address

6-11-1 Omori-nishi Ohta-ku Tokyo, Japan

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

東邦大学医療センター大森病院(東京都)


Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 26 Day


Related information

URL releasing protocol

UMIN000016045

Publication of results

Published


Result

URL related to results and publications

respirology 2015 20, 445-452 doi: 10. 1111/resp. 12477

Number of participants that the trial has enrolled

27

Results

Combination treatment with inhaled N-acetylcysteine and oral pirfenidone reduced the rate of annual FVC decline.

Results date posted

2019 Year 04 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2015 Year 02 Month 02 Day

Baseline Characteristics

27patients (23 men and 4 wemen; age 59-82 years

Participant flow

patient with a diagnosis of advanced IPF and a relative decline in FVC of >10% within the previous 6 month

Adverse events

Only pirfenidone adverse event were developed.

Outcome measures

Decline of FVC

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2009 Year 01 Month 10 Day

Date of IRB

2009 Year 10 Month 02 Day

Anticipated trial start date

2009 Year 10 Month 03 Day

Last follow-up date

2013 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2014 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 12 Month 24 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=R000018649


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name