UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017640
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

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Basic information

Public title

Patients'characteristic survey concomitantly to the Post Marketing Surveillance(PMS) of Spiriva Respimat

Acronym

Patients'characteristic survey

Scientific Title

Patients'characteristic survey concomitantly to the Post Marketing Surveillance(PMS) of Spiriva Respimat

Scientific Title:Acronym

Patients'characteristic survey

Region

Japan


Condition

Condition

Bronchial asthma

Classification by specialty

Medicine in general Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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

Basic objectives2

Others

Basic objectives -Others

This survey is designed to assess the characteristics in patients with severe persistent asthma.

Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

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

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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Yasunori
Middle name
Last name Suga

Organization

Nippon Boehringer Ingelheim Co.,LTD

Division name

Clinical Development & Medical Affairs,Medical Development, Medicine & QRPE

Zip code

141-6017

Address

2-1-1 Osaki,Shinagawa-ku,Tokyo

TEL

03-6417-2228

Email

yasunori.suga@boehringer-ingelheim.com


Public contact

Name of contact person

1st name Yasunori
Middle name
Last name Suga

Organization

Nippon Boehringer Ingelheim Co.,LTD

Division name

Clinical Development & Medical Affairs,Medical Development, Medicine & QRPE

Zip code

141-6017

Address

2-1-1 Osaki,Shinagawa-ku,Tokyo

TEL

03-6417-2228

Homepage URL


Email

yasunori.suga@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

Iryo kenko shigen kaihatsu

Address

4-38-7 Higashiikebukuro toshima

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

2015 Year 05 Month 22 Day


Related information

URL releasing protocol

http://www.pieronline.jp/content/article/0289-8020/39110/953

Publication of results

Published


Result

URL related to results and publications

http://www.pieronline.jp/content/article/0289-8020/39110/953

Number of participants that the trial has enrolled

256

Results

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.

Results date posted

2020 Year 08 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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.

Participant flow

Continuous survery, same physician in same hospital or clinics for registration.

Adverse events

NA

Outcome measures

Patients Background

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 05 Month 09 Day

Date of IRB

2015 Year 06 Month 01 Day

Anticipated trial start date

2015 Year 06 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2017 Year 10 Month 16 Day

Date analysis concluded

2018 Year 05 Month 18 Day


Other

Other related information

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


Management information

Registered date

2015 Year 05 Month 21 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=R000020433


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name