UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019964 |
|---|---|
| Receipt number | 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 14:10:01 |
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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
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
mhojo@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022418
