UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039091 |
|---|---|
| Receipt number | R000044583 |
| Scientific Title | Additive effect of Tiotropium on Fluticasone propionate /Formoterol in patients with asthma-COPD overlap. |
| Date of disclosure of the study information | 2022/01/27 |
| Last modified on | 2022/01/27 15:32:44 |
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Basic information
Public title
Additive effect of Tiotropium on Fluticasone propionate /Formoterol in patients with asthma-COPD overlap.
Acronym
Efficacy of triple therapy in ACO
Scientific Title
Additive effect of Tiotropium on Fluticasone propionate /Formoterol in patients with asthma-COPD overlap.
Scientific Title:Acronym
Additive effect of Tiotropium on Fluticasone/Formoterol in patients with ACO
Region
| Japan |
Condition
Condition
asthma-COPD overlap
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the additive effect of thiotropium on fluticasone propionate in patients with asthma-COPD overlap.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of forced expiriratory volume in one second, a respiratory function test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Additional treatment of Tiotropium on Fluticasone propionate /Formoterol
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
| 40 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
age over 40 years old
Patients with asthma-COPD overlap as follow
past history of episodic wheezeing
bronchial hyperrectivity of 20% fall of FEV1 after inhalation of methacholine, or bronchial reversivirity of 12% and 200 ml improvement of FEV1 after inhalation of bronchodilator.
Without cardiac asthma
Under 70% of FEV1/FVC
Under 80% of FEV1 after bronchodilator therapy
Patients with asthma-COPD overlap diagnosed by treated by 250microg/10microg of Fluticasone propionate /Formoterol
Outpatient with stable symptoms
Agreement for the enrollment of this study
Key exclusion criteria
1) Patients with unstable symptoms
2) Patients needed hospitalization because of infectious diseases
3) Patients with hospitalization within 8 weeks
4) Patients with severe hepatic or renal disease
5) Patients with uncontrolled diabes mellitus
6) Female with pregnancy
7) Female breast-feeding baby
8) Patients enrolled by clinical trials within 3 month
9) Patients recognized as insufficient
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Ishiura |
Organization
Kansai Medical University Medical Center
Division name
Division of Respiratory, Oncology and Allergy
Zip code
570-8507
Address
10-15 Fumizono-cho, moriguchi city, Osaka
TEL
0669921001
ishiuray@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Ishiura |
Organization
Kansai Medical University Medical Center
Division name
Division of Respiratory, Oncology and Allergy
Zip code
570-8507
Address
10-15 Fumizono-cho, moriguchi city, Osaka
TEL
0669921001
Homepage URL
ishiuray@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Medical Center
Address
10-15 Fumizono-cho, moriguchi city, Osaka
Tel
0669921001
ishiuray@takii.kmu.ac.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
| 2022 | Year | 01 | Month | 27 | 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
18
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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 08 | Day |
Last modified on
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044583
