Unique ID issued by UMIN | UMIN000017640 |
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Receipt number | R000020433 |
Scientific Title | Patients'characteristic survey concomitantly to the Post Marketing Surveillance(PMS) of Spiriva Respimat |
Date of disclosure of the study information | 2015/05/22 |
Last modified on | 2020/08/24 19:46:11 |
Patients'characteristic survey concomitantly to the Post Marketing Surveillance(PMS) of Spiriva Respimat
Patients'characteristic survey
Patients'characteristic survey concomitantly to the Post Marketing Surveillance(PMS) of Spiriva Respimat
Patients'characteristic survey
Japan |
Bronchial asthma
Medicine in general | Pneumology |
Others
NO
This survey is designed to assess the characteristics of enrolled people with asthma and potential channelling in patients with severe persistent asthma who are naive to Spiriva Respimat, receiving ICS maintenance therapy and initiate an additional anti-asthmatic drug that is not Spiriva
Others
This survey is designed to assess the characteristics in patients with severe persistent asthma.
Others
Pragmatic
Phase IV
Patients characteristics (sex, birth day, height, weight, smoking status/pack-year, asthma severity, date of onset,the number of hospitalizations and emergency visits), condition of new prescription of anti-asthma drugs, medical history/concomitant disease, concomitant medication, concomitant therapy, pulmonary function test, level of asthma control, QOL
Observational
15 | years-old | <= |
Not applicable |
Male and Female
1)Patients diagnosed with severe persistent bronchial asthma
2)Patients aged >= 15 years
3)Patients who receive ICS maintenance therapy and at least one anti-asthmatic drug (LABA, leukotriene modifier, xanthines, anti-IgE antibody and oral corticosteroid) except for Spiriva Respimat.
4)Patients with informed consent sequentially enrolled in the same hospitals, the same clinics and by the same physicians as the PMS study during the same period
1)Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat
2)Patients who have been enrolled this study before
300
1st name | Yasunori |
Middle name | |
Last name | Suga |
Nippon Boehringer Ingelheim Co.,LTD
Clinical Development & Medical Affairs,Medical Development, Medicine & QRPE
141-6017
2-1-1 Osaki,Shinagawa-ku,Tokyo
03-6417-2228
yasunori.suga@boehringer-ingelheim.com
1st name | Yasunori |
Middle name | |
Last name | Suga |
Nippon Boehringer Ingelheim Co.,LTD
Clinical Development & Medical Affairs,Medical Development, Medicine & QRPE
141-6017
2-1-1 Osaki,Shinagawa-ku,Tokyo
03-6417-2228
yasunori.suga@boehringer-ingelheim.com
Nippon Boehringer Ingelheim Co.,LTD
Nippon Boehringer Ingelheim Co.,LTD
Profit organization
Iryo kenko shigen kaihatsu
4-38-7 Higashiikebukuro toshima
03-5904-8534
jdw06164@nifty.com
NO
2015 | Year | 05 | Month | 22 | Day |
http://www.pieronline.jp/content/article/0289-8020/39110/953
Published
http://www.pieronline.jp/content/article/0289-8020/39110/953
256
Mean value of pack year in the PMS was much higher than that of the BCS. The percentages of ex smokers were higher in the PMS compared with BCS. The prevalence of asthma exacerbationin the PMS was higher than that of the BCS. ICS/LABA was the most frequent in both PMS and BCS.There were more poorly controlled patients with asthma in the PMS compared with the BCS. The proportion of patients who had more severe asthma was higher in the PMS compared with the BCS.
2020 | Year | 08 | Month | 17 | Day |
Mean value of pack year in the PMS was much higher than that of the BCS. For smoking status, the percentages of ex smokers were higher in the PMS compared with BCS. The prevalence of asthma exacerbation at baseline in the PMS was higher than that of the BCS. For concomitant medication at baseline, inhaled corticosteroids long acting beta2 agonist combination drug was the most frequent in both PMS and BCS, followed by leukotriene receptor antagonist and theophylline. There were more poorly controlled patients with asthma in the PMS compared with the BCS. Regarding other asthma disease conditions at baseline, the proportion of patients who had more severe asthma was higher in the PMS compared with the BCS.
Continuous survery, same physician in same hospital or clinics for registration.
NA
Patients Background
Completed
2015 | Year | 05 | Month | 09 | Day |
2015 | Year | 06 | Month | 01 | Day |
2015 | Year | 06 | Month | 01 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 10 | Month | 16 | Day |
2018 | Year | 05 | Month | 18 | Day |
Patients characteristics (sex, birth day, height, weight, smoking status/pack-year, asthma severity, date of onset,the number of hospitalizations and emergency visits) , condition of new prescription of anti-asthma drugs that is not Spiriva Respimat, medical history/concomitant disease, concomitant medication, concomitant therapy, pulmonary function test, level of asthma control, QOL
2015 | Year | 05 | Month | 21 | Day |
2020 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020433
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