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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019964
Receipt No. R000022418
Scientific Title The add-on effect of Tiotropium bromide to ICS/LABA combination inhaler for the patients with severe uncontrolled asthma
Date of disclosure of the study information 2015/11/28
Last modified on 2019/09/12

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Basic information
Public title The add-on effect of Tiotropium bromide to ICS/LABA combination inhaler for the patients with severe uncontrolled asthma
Acronym Add-on effect of TIO for severe asthmatics
Scientific Title The add-on effect of Tiotropium bromide to ICS/LABA combination inhaler for the patients with severe uncontrolled asthma
Scientific Title:Acronym Add-on effect of TIO for severe asthmatics
Region
Japan

Condition
Condition bronchial asthma
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the clinical usefulness of TIO, especially its add-on effect on lung function, among severe asthmatics who have already received treatment with high-dose ICS/LABA combination inhaler
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes add-on improvement of respiratory resistance and reactance measured by Mostgraph-01 after inhalation of TIO or salbutamol to usual treatment with ICS/LABA combination after 6 months treatment period.
Key secondary outcomes ACT scores, FeNO values, and spirometry values were also compared before and after 6 months treatment with TIO treatment.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tiotropium bromide
once daily two puffs
6 months treatment
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Poorly controlled moderate to severe asthmatics followed at our hospital, aged 20-80 years old, receiving Tiotropium Respimat(TIO) 2puffs/day for more than 6 months even with GINA step 4 or 5 standard treatment as described below; ICS/LABA combination (equivalent FP 1000microgram/day or more; i.e. Salmeterol/Fluticasone (SFC) 500 DPI twice daily, SFC 250 pMDI 4puffs/ day, or budesonide/formoterol (FBC) 160/4.5 8puffs/day or frequent SMART treatment) with other controller drugs.
Key exclusion criteria apparent COPD patient
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Hojo
Organization National Center for Global Health and Medicine
Division name Division of Respiratory Medicine
Zip code 1628655
Address 1-21-1Toyama, Shinjuku, Tokyo, Japan
TEL 03-3202-7181
Email mhojo@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Hojo
Organization National Center for Global Health and Medicine
Division name Division of Respiratory Medicine
Zip code 1628655
Address 1-21-1Toyama, Shinjuku, Tokyo, Japan
TEL 03-3202-7181
Homepage URL
Email mhojo@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization National Center for Global Health and Medicine
Address 1-21-1Toyama, Shinjuku, Tokyo, Japan
Tel 03-3202-7181
Email rinrijm@hosp.ncgm.go.jp

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 11 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 03 Month 20 Day
Date of IRB
2014 Year 05 Month 30 Day
Anticipated trial start date
2014 Year 11 Month 20 Day
Last follow-up date
2018 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 27 Day
Last modified on
2019 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022418

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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