Unique ID issued by UMIN | UMIN000005793 |
---|---|
Receipt number | R000006225 |
Scientific Title | Open-label study of tiotropium/pirfenidone for idiopathic pulmonary fibrosis with emphysema |
Date of disclosure of the study information | 2011/06/16 |
Last modified on | 2016/06/16 09:42:36 |
Open-label study of tiotropium/pirfenidone for idiopathic pulmonary fibrosis with emphysema
PS study
Open-label study of tiotropium/pirfenidone for idiopathic pulmonary fibrosis with emphysema
PS study
Japan |
Idiopathic pulmonary fibrosis (IPF) with centrilobular emphysema (CLE)
Pneumology |
Others
NO
To evaluate the efficacy and the safety of tiotropium and pirfenidone for IPF with CLE
Safety,Efficacy
Change in FVC,FEV1,DLco, and DLco/VA
Time to progression
Progression free survival
Dyspnea (SGRQ)
Change in brain natiuretic peptide
Change in predicted right ventricular
pressure
Change in high-resolution CT findings
Change in 6 minutes walk test
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Uncontrolled
2
Treatment
Medicine |
tiotropium for 8 weeks and then
tiotropium + pirfenidone for 44 weeks
pirfenidone 44 weeks and then
tiotropium + pirfenidone for 8 weeks
40 | years-old | <= |
Not applicable |
Male and Female
Patients with IPF diagnosed by ATS/ERS/JRS guideline 2011 and with CLE
Patients who are not eligible for the administration of tiotropium or pirfenidone.
Patients who cannot undergo pulmonary function tests and/or 6 minutes walk test.
60
1st name | |
Middle name | |
Last name | Yutaka Usui |
Saitma Medical University
Department of Respiratory Medicine
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
0492761319
yusui@saitama-med.ac.jp
1st name | |
Middle name | |
Last name | Yutaka Usui |
Saitma Medical University
Department of Respiratory Medicine
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
0492761319
yusui@saitama-med.ac.jp
Saitama Medical University
None
Self funding
NO
2011 | Year | 06 | Month | 16 | Day |
Unpublished
Open public recruiting
2009 | Year | 10 | Month | 07 | Day |
2009 | Year | 11 | Month | 01 | Day |
2011 | Year | 06 | Month | 16 | Day |
2016 | Year | 06 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006225
Research Plan | |
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Research case data | |
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