UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009904
Receipt number R000011605
Scientific Title [Study of Tulobuterol Patch] Diagnostic procedure for infantile bronchial asthma <Pilot Study> -Evaluation of Tulobuterol Patch using pulse oximetry-
Date of disclosure of the study information 2013/01/30
Last modified on 2013/01/30 13:53:23

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Basic information

Public title

[Study of Tulobuterol Patch]
Diagnostic procedure for infantile bronchial asthma <Pilot Study>
-Evaluation of Tulobuterol Patch using pulse oximetry-

Acronym

[Study of Tulobuterol Patch]
Diagnostic procedure for infantile bronchial asthma <Pilot Study>
-Evaluation of Tulobuterol Patch using pulse oximetry-

Scientific Title

[Study of Tulobuterol Patch]
Diagnostic procedure for infantile bronchial asthma <Pilot Study>
-Evaluation of Tulobuterol Patch using pulse oximetry-

Scientific Title:Acronym

[Study of Tulobuterol Patch]
Diagnostic procedure for infantile bronchial asthma <Pilot Study>
-Evaluation of Tulobuterol Patch using pulse oximetry-

Region

Japan


Condition

Condition

infantile bronchial asthma

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of a long-acting beta-2 agonist (Tulobuterol patch) on oxygen saturation (SpO2) measured with pulse oximetry in the early morning after dosing as compared with those that before dosing to explore differential diagnostic procedure for infant asthma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

SpO2 that will be measured using pulse oximetry for at least three hours around 4 am while the patient is sleeping

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

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Hokunalin tape 0.5 mg is applied on chest, back, or upper arm at 8 pm once daily.

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

1 years-old <=

Age-upper limit

4 years-old >

Gender

Male and Female

Key inclusion criteria

i.Patients who present with respiratory symptom and have suspected bronchial asthma.
ii.Patients who have not had a major attack of bronchial asthma during one week prior to initiation of study drug.

Key exclusion criteria

i.Patients receiving an inhaled long-acting beta-2 agonist (inhaled salmeterol) or receiving an oral short-acting beta-2 agonist continuously.
ii.Patients who have known hypersensitivity to Tulobuterol Patch or have a skin disease, including atopic dermatitis, and are considered inappropriate to use Tulobuterol Patch.
iii.Patients who have thyroid hyperfunction disorders, hypertension, cardiac disorder, or diabetes concurrently, and are considered inappropriate to use a beta-2 antagonist.
iv.Patients who have experienced serious adverse drug reactions of Tulobuterol.
v.Patients who, in the opinion of the investigator are inappropriate for inclusion in the study.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naomi Kondo

Organization

Graduate School of Medicine
Gifu University

Division name

Pediatrics

Zip code


Address

1-1 Yanagito, Gifu, Japan

TEL

058-230-6386

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takahide Teramoto

Organization

Graduate School of Medicine

Division name

Pediatrics

Zip code


Address

1-1 Yanagito, Gifu, Japan

TEL

058-230-6386

Homepage URL


Email



Sponsor or person

Institute

Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Graduate 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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2013 Year 01 Month 30 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


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

Enrolling by invitation

Date of protocol fixation

2011 Year 11 Month 02 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 30 Day

Last modified on

2013 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011605


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name