UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Glycopyrronium added to Budesonide/Formoterol in patients with Asthma-COPD overlap syndrome
Title of the study (Brief title)	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	Yoshihisa Ishiura
Organization	Toyama City Hospital
Division name	Respiratory Medicine
Address	2-1 Imaizumi-Hokubu-machi, Toyama City
TEL	076-422-1112
Email	ishiura@tch.toyama.toyama.jp

Public contact
Name of contact person	Yoshihisa Ishiura
Organization	Toyama City Hospital
Division name	Respiratory Medicine
Address	2-1 Imaizumi-Hokubu-machi, Toyama City
TEL	076-422-1112
Homepage URL
Email	ishiura@tch.toyama.toyama.jp

Sponsor
Institute	Toyama City Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030605