UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023629
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public 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
Acronym Baseline characteristics of patients with COPD (chronic bronchitis, emphysema) who require LABA and LAMA (BI trial number 1237.48)
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
Scientific Title:Acronym Baseline characteristics of patients with COPD (chronic bronchitis, emphysema) who require LABA and LAMA (BI trial number 1237.48)
Region
Japan

Condition
Condition COPD(chronic bronchitis, emphysema)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Others
Basic objectives -Others This survey is designed to assess baseline characteristics without the information regarding safety and effectiveness.
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 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
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Shuhei
Middle name
Last name Nakamura
Organization Nippon Boehringer Ingelheim Co.,LTD
Division name TA Asthma & COPD, Primary Care Medicine, Medicine Division
Zip code 1416017
Address 2-1-1 Osaki,Shinagawa-ku,Tokyo
TEL 03-6417-2471
Email shuhei.nakamura@boehringer-ingelheim.com

Public contact
Name of contact person
1st name Shuhei
Middle name
Last name Nakamura
Organization Nippon Boehringer Ingelheim Co.,LTD
Division name TA Asthma & COPD, Primary Care Medicine, Medicine Division
Zip code 1416017
Address 2-1-1 Osaki,Shinagawa-ku,Tokyo
TEL 03-6417-2471
Homepage URL
Email shuhei.nakamura@boehringer-ingelheim.com

Sponsor
Institute Nippon Boehringer Ingelheim Co.,LTD
Institute
Department

Funding Source
Organization Nippon Boehringer Ingelheim Co.,LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Iryokenkoshigenkaihatsu kenkyujo
Address NA
Tel 03-5904-8534
Email jdw06164@nifty.com

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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 21 Day

Related information
URL releasing protocol http://www.pieronline.jp/content/article/0289-8020/41040/281
Publication of results Published

Result
URL related to results and publications http://www.pieronline.jp/content/article/0289-8020/41040/281
Number of participants that the trial has enrolled 474
Results 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.
Results date posted
2020 Year 08 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 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.
Participant flow Continuous survery, same physician in same hospital or clinics for registration.
Adverse events NA
Outcome measures NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 20 Day
Date of IRB
2016 Year 08 Month 23 Day
Anticipated trial start date
2016 Year 08 Month 23 Day
Last follow-up date
2018 Year 04 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This survey is designed to assess the characteristics in patients with COPD.

Management information
Registered date
2016 Year 08 Month 15 Day
Last modified on
2020 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027115

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.