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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002921
Receipt No. R000003559
Scientific Title Evaluation of long-term management of pediatric bronchial asthma – Effects of bronchodilators in combination of antileukotrienes –
Date of disclosure of the study information 2009/12/28
Last modified on 2011/11/17

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Basic information
Public title Evaluation of long-term management of pediatric bronchial asthma
– Effects of bronchodilators in combination of antileukotrienes –
Acronym PAB
Scientific Title Evaluation of long-term management of pediatric bronchial asthma
– Effects of bronchodilators in combination of antileukotrienes –
Scientific Title:Acronym PAB
Region
Japan

Condition
Condition asthma
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the long-term management of mild persistent asthma, shown in JPGL, anti-LTs are used as the first-line therapy. Bronchodilators such as theophylline and beta2-agonists are added. In the present study, the add-on effects of tulobuterol patch, a beta2 agonist, on patients receiving anti-LT will be compared with that of theophylline in order to evaluate the efficacy and safety (exacerbation of inflammation) of these major regimens.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Pulmonary function
Morning and evening PEF
2) Airway inflammation: expired NO

Key secondary outcomes 1) Asthma symptoms (evaluate on the basis of the patient diary)
Asthma score: Symptoms, activities of daily living, nocturnal sleep, frequency of attacks, number of days without symptoms
2) Frequency of use of inhaled/oral beta2 agonists (as single doses)
3) Concomitant symptoms (adverse effects for which causal relationship with the treatment cannot be ruled out)
4) Frequency of occurence of adverse effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is 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 tulobuterol patch (TP)
Interventions/Control_2 theophylline (Theo)
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
4 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria &#61569; Children with bronchial asthma under treatment for mild persistent asthma.
&#61570; Children who still have wheezing and dyspnea despite of treatment with an anti-LT.
&#61571; Children who are 4~12 years of age and show stable PEF measurements (note).
Note) Stable PEF measurements are defined as that the difference between the second highest and the highest PEF measurement is lower 15% lower than the highest PEF measurement among three consecutive measurements of PEF.
&#61572; Children who (or whose parents) have given informed consent for participation in the present study.
Key exclusion criteria &#61569; Children who are receiving long-acting beta2 agonists (tulobuterol patch or inhaled salmeterol) or oral beta2 agonists regularly.
&#61570; Children with a history of hypersensitivity to tulobuterol patch, and children with dermal diseases such as atopic dermatitis for whom treatment with tulobuterol patch are considered inappropriate.
&#61571; Children with hyperthyroidism, hypertension, heart disease or diabetes mellitus for whom treatment with beta2 agonists is considered inappropriate.
&#61572; Children with a history of serious adverse effects of tulobuterol.
&#61573; Children with a history of serious adverse effects of theophylline.
&#61574; Children with epilepsy, hyperthyroidism, acute nephritis, congestive heart failure or liver disorder for whom treatment with theophylline is considered inappropriate.
&#61575; Children with neurological dispositions (e.g., epilepsy, convulsions and abnormal EEG)
&#61576; Children with fever
&#61577; Any other children for whom participation in the survey is considered inappropriate by the attending physicians.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Katsunuma
Organization The Jikei University School of Medicine
Division name Department of Pediatrics
Zip code
Address 3-25-8, Nishi-Shinbashi, Minatoku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Saito, Kumiko Ohta
Organization PARG
Division name PARG
Zip code
Address
TEL
Homepage URL
Email otak@mie-m.hosp.go.jp

Sponsor
Institute PARG (Pediatric Asthma Research Group)
Institute
Department

Funding Source
Organization Japan Allergy Foundation
Organization
Division
Category of Funding Organization Other
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
2009 Year 12 Month 28 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 Completed
Date of protocol fixation
2007 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 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
2009 Year 12 Month 20 Day
Last modified on
2011 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003559

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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