UMIN-CTR Clinical Trial

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

asthma

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

4

years-old

<=

Age-upper limit

12

years-old

>=

Gender

Male and Female

Key inclusion criteria

 Children with bronchial asthma under treatment for mild persistent asthma.
 Children who still have wheezing and dyspnea despite of treatment with an anti-LT.
 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.
 Children who (or whose parents) have given informed consent for participation in the present study.

Key exclusion criteria

 Children who are receiving long-acting beta2 agonists (tulobuterol patch or inhaled salmeterol) or oral beta2 agonists regularly.
 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.
 Children with hyperthyroidism, hypertension, heart disease or diabetes mellitus for whom treatment with beta2 agonists is considered inappropriate.
 Children with a history of serious adverse effects of tulobuterol.
 Children with a history of serious adverse effects of theophylline.
 Children with epilepsy, hyperthyroidism, acute nephritis, congestive heart failure or liver disorder for whom treatment with theophylline is considered inappropriate.
 Children with neurological dispositions (e.g., epilepsy, convulsions and abnormal EEG)
 Children with fever
 Any other children for whom participation in the survey is considered inappropriate by the attending physicians.

Target sample size

140

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

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

Institute

PARG (Pediatric Asthma Research Group)

Institute

Department

Personal name

Organization

Japan Allergy Foundation

Organization

Division

Category of Funding Organization

Other

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

Date of disclosure of the study information

2009

Year

12

Month

28

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

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 related information

Registered date

2009

Year

12

Month

20

Day

Last modified on

2011

Year

11

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003559