Unique ID issued by UMIN | UMIN000016045 |
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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 |
A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.
Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.
A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.
Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.
Japan |
Idiopathic pulmonary fibrosis
Pneumology |
Others
NO
To evaluate the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine compared with pirfenidone alone for idiopathic pulmonary fibrosis
Safety,Efficacy
Exploratory
Change in forced vital capacity
Progression-free survival time
Incidence of acute exacerbation
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
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.
Pirfenidone 1200-1800mg (control group)
20 | years-old | <= |
Not applicable |
Male and Female
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
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
20
1st name | Sakae |
Middle name | |
Last name | Homma |
Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo,
Department of Respiratory Medicine
143-8541
6-11-1 Omori-nishi, Ota-ku, Tokyo,
03-3762-4151
susumu1029@med.toho-u.ac.jp
1st name | susumu |
Middle name | |
Last name | Sakamoto |
Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo,
Department of Respiratory Medicine
143-8541
6-11-1 Omori-nishi, Ota-ku, Tokyo,
03-3762-4151
susumu1029@med.toho-u.ac.jp
Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo,
None
Self funding
Toho university omori medical center
6-11-1 Omori-nishi Ohta-ku Tokyo, Japan
0337624151
somu.omori@jim.toho-u.ac.jp
NO
東邦大学医療センター大森病院(東京都)
2014 | Year | 12 | Month | 26 | Day |
UMIN000016045
Published
respirology 2015 20, 445-452 doi: 10. 1111/resp. 12477
27
Combination treatment with inhaled N-acetylcysteine and oral pirfenidone reduced the rate of annual FVC decline.
2019 | Year | 04 | Month | 30 | Day |
2015 | Year | 02 | Month | 02 | Day |
27patients (23 men and 4 wemen; age 59-82 years
patient with a diagnosis of advanced IPF and a relative decline in FVC of >10% within the previous 6 month
Only pirfenidone adverse event were developed.
Decline of FVC
Completed
2009 | Year | 01 | Month | 10 | Day |
2009 | Year | 10 | Month | 02 | Day |
2009 | Year | 10 | Month | 03 | Day |
2013 | Year | 12 | Month | 31 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 12 | Month | 24 | Day |
2019 | Year | 04 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018649
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