UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000016045 |
| Receipt No. | 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 (Ver. 4) |
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| 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 |
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| Condition | ||
| Condition | Idiopathic pulmonary fibrosis | |
| Classification by specialty |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 20 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| 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 | ||||||
| susumu1029@med.toho-u.ac.jp | |||||||
| Public contact | |||||||
| 1st name of contact person |
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| 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 | |
| Institute | Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo, |
| Institute | |
| Department | |
| 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 |
| 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results |
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| Baseline Characteristics | 27patients (23 men and 4 wemen; age 59-82 years |
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| Participant flow | patient with a diagnosis of advanced IPF and a relative decline in FVC of >10% within the previous 6 month |
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| Adverse events | Only pirfenidone adverse event were developed. |
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| Outcome measures | Decline of FVC |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Other | |
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| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018649 |
