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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
