Unique ID issued by UMIN | UMIN000023629 |
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Receipt number | R000027115 |
Scientific Title | Baseline characteristics of patients with COPD (chronic bronchitis, emphysema) who require LABA and LAMA (both free and fixed combination) for maintenance therapy other than tiotropium+olodaterol fixed dose combination (Tio+Olo FDC) assessed in parallel with the PMS of Tio+Olo FDC Respimat, BI trial number 1237.34 |
Date of disclosure of the study information | 2016/08/21 |
Last modified on | 2020/08/24 19:06:24 |
Baseline characteristics of patients with COPD (chronic bronchitis, emphysema) who require LABA and LAMA (both free and fixed combination) for maintenance therapy other than tiotropium+olodaterol fixed dose combination (Tio+Olo FDC) assessed in parallel with the PMS of Tio+Olo FDC Respimat, BI trial number 1237.34
Baseline characteristics of patients with COPD (chronic bronchitis, emphysema) who require LABA and LAMA (BI trial number 1237.48)
Baseline characteristics of patients with COPD (chronic bronchitis, emphysema) who require LABA and LAMA (both free and fixed combination) for maintenance therapy other than tiotropium+olodaterol fixed dose combination (Tio+Olo FDC) assessed in parallel with the PMS of Tio+Olo FDC Respimat, BI trial number 1237.34
Baseline characteristics of patients with COPD (chronic bronchitis, emphysema) who require LABA and LAMA (BI trial number 1237.48)
Japan |
COPD(chronic bronchitis, emphysema)
Pneumology |
Others
NO
This survey is designed to assess baseline characteristics and potential channelling in patients with COPD (chronic bronchitis, emphysema) who require both LABA and LAMA (both free and fixed combination) for maintenance therapy other than Tio+Olo FDC sequentially enrolled in the half of sites in which other LABA/LAMA FDC or free combination could be prescribed and could participate in the PMS, in parallel in order to allow the same physicians can prescribe LABA/LAMA FDCs or free combinations during the same period.
Others
This survey is designed to assess baseline characteristics without the information regarding safety and effectiveness.
Others
Pragmatic
Phase IV
Demographics(Sex,date of birth ,height, weight, smoking history, reason of LAMA+LABA administration), COPD status, LAMA + LABA combination administration status, Medical history, Concomitant disease,Previous/concomitant therapies, Concomitant/ past medications, CAT, FVC and FEV1
Observational
Not applicable |
Not applicable |
Male and Female
Patients who are newly prescribed LABA + LAMA combination (both free and fixed combination) or who are switched to new LABA + LAMA combination from conventional LABA and LAMA combination.
Patients with informed consent (excepted in case of opt-out procedure) sequentially to be enrolled by the same physicians in the PMS sites.
Patients who are prescribed Tio+Olo FDC, Patients who have already been registered in this study once (re-entry of patients is not allowed).
Patients who are participating in a clinical trial or registry.
Patients who have a contraindication to Tio+Olo FDC defined in the package insert for Tio+Olo FDC.
500
1st name | Shuhei |
Middle name | |
Last name | Nakamura |
Nippon Boehringer Ingelheim Co.,LTD
TA Asthma & COPD, Primary Care Medicine, Medicine Division
1416017
2-1-1 Osaki,Shinagawa-ku,Tokyo
03-6417-2471
shuhei.nakamura@boehringer-ingelheim.com
1st name | Shuhei |
Middle name | |
Last name | Nakamura |
Nippon Boehringer Ingelheim Co.,LTD
TA Asthma & COPD, Primary Care Medicine, Medicine Division
1416017
2-1-1 Osaki,Shinagawa-ku,Tokyo
03-6417-2471
shuhei.nakamura@boehringer-ingelheim.com
Nippon Boehringer Ingelheim Co.,LTD
Nippon Boehringer Ingelheim Co.,LTD
Profit organization
Iryokenkoshigenkaihatsu kenkyujo
NA
03-5904-8534
jdw06164@nifty.com
NO
2016 | Year | 08 | Month | 21 | Day |
http://www.pieronline.jp/content/article/0289-8020/41040/281
Published
http://www.pieronline.jp/content/article/0289-8020/41040/281
474
Mild COPD was slightly higher in the BCS than in the PMS. The mean post dose percent FEV1 and FEV1 FVC were numerically slightly higher in the BCS than in the PMS. The proportion of comorbidities, benign prostatic hyperplasi and gastroesophageal reflux disease, was numerically higher and lower, respectively, in the BCS than in the PMS. The proportion of previously received respiratory medication was higher in the BCS than in the PMS.
2020 | Year | 08 | Month | 24 | Day |
Mild COPD was slightly higher in the BCSthan in the PMS. The mean postdose percent FEV1 and FEV1FVC were numerically slightly higher in the BCS than in the PMS. The proportion of comorbidities, benign prostatic hyperplasia and gastroesophageal reflux disease, was numerically higher and lower than in the PMS.
The proportion of previously received respiratory medication was higher in the BCS than in the PMS.
Continuous survery, same physician in same hospital or clinics for registration.
NA
NA
Completed
2016 | Year | 07 | Month | 20 | Day |
2016 | Year | 08 | Month | 23 | Day |
2016 | Year | 08 | Month | 23 | Day |
2018 | Year | 04 | Month | 03 | Day |
This survey is designed to assess the characteristics in patients with COPD.
2016 | Year | 08 | Month | 15 | Day |
2020 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027115
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