UMIN-CTR Clinical Trial

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
Email	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
Email	ishiuray@takii.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Medical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044583