UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of efficacy between long-acting muscarinic antagonist (LAMA) and leukotriene receptor antagonist (LTRA) as step-up treatment in patients with uncontrolled bronchial asthma
Title of the study (Brief title)	Comparison of efficacy between LAMA and LTRA in uncontrolled asthma
Region	Japan

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

Objectives
Narrative objectives1	To compare the efficacy between long-acting muscarinic antagonist (LAMA) and leukotriene receptor antagonist (LTRA) as step-up treatment in patients with uncontrolled bronchial asthma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	Change from baseline (0 week) in FEV1 after 12 weeks of treatment
Key secondary outcomes	Secondly end points are change in QOL (ACT score, ACQ score), parameters of pulmonary function (%FEV1, FEV1/FVC, PEF, MMF, respiratory resistance, respiratory reactance), and fractional exhaled nitric oxide after 12 weeks of treatment from baseline (0 week). Adverse events are reported throughout the study.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tiotropium 2.5ug two inhalations, once daily for 12 weeks
Interventions/Control_2	Montelukast 10mg oral administration, once daily for 12 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with uncontrolled asthma under the treatment of moderate or high dose of ICS/LABA for over 4 weeks. They haven't treated with LAMA or LTRA for asthma.
Key exclusion criteria	(1) Treatment with oral or intravenous corticosteroids, hospitalization, emergency or unexpected visit within 4 weeks (2) Angle closure glaucoma, symptomatic prostatic hypertrophy and uncontrolled heart failure (3) Active other pulmonary diseases except for asthma and COPD (4) Vocal cord disfunction (5) Previous history of hypersensitivity to tiotropium or montelukast (6) Pregnancy or lactation (7) Considered to be unsuitable by the physicians
Target sample size	200

Research contact person
Name of lead principal investigator	Takafumi Suda
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	Mitsuru Niwa
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka
TEL	053-435-2263
Homepage URL
Email	mtr.nw@hama-med.ac.jp

Sponsor
Institute	Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
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	聖隷三方原病院（静岡県）、聖隷浜松病院（静岡県）、浜松医療センター（静岡県）、独立行政法人労働者健康福祉機構浜松労災病院（静岡県）、JA静岡厚生連遠州病院（静岡県）、浜松赤十字病院（静岡県）、独立行政法人国立病院機構天竜病院（静岡県）、市立湖西病院（静岡県）、磐田市立総合病院（静岡県）、藤枝市立総合病院（静岡県）、静岡県立総合病院（静岡県）、静岡市立静岡病院（静岡県）、静岡市立清水病院（静岡県）、静岡赤十字病院（静岡県）、静岡済生会病院（静岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 11 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 06 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	2016 Year 06 Month 11 Day
Last modified on	2018 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025945