UMIN-CTR Clinical Trial

Public title

Comparison of efficacy between long-acting muscarinic antagonist (LAMA) and leukotriene receptor antagonist (LTRA) as step-up treatment in patients with uncontrolled bronchial asthma

Acronym

Comparison of efficacy between LAMA and LTRA in uncontrolled asthma

Scientific Title

Comparison of efficacy between long-acting muscarinic antagonist (LAMA) and leukotriene receptor antagonist (LTRA) as step-up treatment in patients with uncontrolled bronchial asthma

Scientific Title:Acronym

Comparison of efficacy between LAMA and LTRA in uncontrolled asthma

Region

Japan

Condition

Bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Takafumi Suda

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka

TEL

053-435-2263

Email

suda@hama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Mitsuru Niwa

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code

Address

1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka

TEL

053-435-2263

Homepage URL

Email

mtr.nw@hama-med.ac.jp

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

06

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Open public recruiting

Date of protocol fixation

2016

Year

02

Month

01

Day

Date of IRB

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

Other related information

Registered date

2016

Year

06

Month

11

Day

Last modified on

2018

Year

12

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025945