UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000017640
Receipt No. 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 (Ver. 16)

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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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020433