UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023629
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

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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 or person

Institute

Nippon Boehringer Ingelheim Co.,LTD

Institute

Department

Personal name



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

Value
https://center6.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