UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of tiotropium versus montelukast on airway inflammation and remodeling in asthma
Title of the study (Brief title)	Effect of tiotropium versus montelukast on airway inflammation and remodeling in asthma
Region	Japan

Condition
Condition	Bronchial asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of tiotropium on clinical index of asthma comapred with montelukast
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Indices of chest CT, FeNO(baseline and after 6 months treatment)
Key secondary outcomes	Parameters of pulmonary function Cell counts of induced sputum Scores of quality of life

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tiotropium treatment group Respimat (2.5mcg) 2 inhalation once daily Treatment period 6 months
Interventions/Control_2	Montelukast treatment group Kipres (10mg) oral once daily Treatment period 6 months
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	16 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Symptomatic asthma patients who have been treated with ICS+LABA
Key exclusion criteria	1. Patients who have any coexisting pulmonary diseases other than asthma 2. Pregnancy or lactation 3. Patients have hypersensitivity to tiotropium or montelukast 4. Patients judged to be unsuitable by the doctors
Target sample size	100

Research contact person
Name of lead principal investigator	Makoto Hoshino
Organization	Atami Hospital International University of Health and Welfare
Division name	Division of Clinical Allergy, Department of Internal Medicine
Address	13-1 Higashikaigan-cho, Atami, Shizuoka
TEL	0557-81-9171
Email	hoshino@iuhw.ac.jp

Public contact
Name of contact person	Makoto Hoshino
Organization	Atami Hospital, International University of Health and Welfare
Division name	Division of Clinical Allergy, Department of Internal Medicine
Address	13-1 Higashikaigan-cho, Atami, Shizuoka
TEL	0557-81-9171
Homepage URL
Email	hoshino@iuhw.ac.jp

Sponsor
Institute	Atami Hospital International University of Health and Welfare
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 09 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 27 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 16 Day
Last modified on	2018 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022017