UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026651 |
|---|---|
| Receipt number | R000030605 |
| Scientific Title | Efficacy of Glycopyrronium added to Budesonide/Formoterol in patients with Asthma-COPD overlap syndrome |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/03/22 17:53:14 |
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Basic information
Public title
Efficacy of Glycopyrronium added to Budesonide/Formoterol in patients with Asthma-COPD overlap syndrome
Acronym
Efficacy of triple therapy in patients with Asthma-COPD overlap syndrome
Scientific Title
Efficacy of Glycopyrronium added to Budesonide/Formoterol in patients with Asthma-COPD overlap syndrome
Scientific Title:Acronym
Efficacy of triple therapy in patients with Asthma-COPD overlap syndrome
Region
| Japan |
Condition
Condition
patients with Asthma-COPD overlap syndrom
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the additive effect of Glycopyrronium on Budesonide/Formoterol in patients with asthma-COPD overlap syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of respiratory functions (FEV1, FVC) after 4 week treatment
Key secondary outcomes
Improvement of respiratory symptoms after 4 week treatment
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with ACOS treated by Budesonide/Formoterol 640 micro g/18micri g/day.
Interventions/Control_2
Glycopyrronium 50 micro g/day is administered 4 weeks in patients with ACOS treated by Budesonide/Formoterol 640 micro g/18micri g/day.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with stable asthma COPD overlap syndrome
Key exclusion criteria
Patients with unstable asthma COPD overlap syndrome
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City Hospital
Division name
Respiratory Medicine
Zip code
Address
2-1 Imaizumi-Hokubu-machi, Toyama City
TEL
076-422-1112
ishiura@tch.toyama.toyama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City Hospital
Division name
Respiratory Medicine
Zip code
Address
2-1 Imaizumi-Hokubu-machi, Toyama City
TEL
076-422-1112
Homepage URL
ishiura@tch.toyama.toyama.jp
Sponsor or person
Institute
Toyama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama City Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 22 | Day |
Last modified on
| 2017 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030605
