UMIN-CTR Clinical Trial

Public title

Clinical efficacy of Budesonide Turbuhaler in pediatric patients with bronchial asthma
-Evaluation of JPAC scores and parent/guardian satisfaction-

Acronym

Clinical efficacy of Budesonide Turbuhaler in pediatric patients with bronchial asthma
-Evaluation of JPAC scores and parent/guardian satisfaction-

Scientific Title

Clinical efficacy of Budesonide Turbuhaler in pediatric patients with bronchial asthma
-Evaluation of JPAC scores and parent/guardian satisfaction-

Scientific Title:Acronym

Clinical efficacy of Budesonide Turbuhaler in pediatric patients with bronchial asthma
-Evaluation of JPAC scores and parent/guardian satisfaction-

Region

Japan

Condition

bronchial asthma

Classification by specialty

Pneumology	Clinical immunology	Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate symptomatic improvement, its influence on parent/guardian satisfaction, and the safety after 12 weeks of switching to ICS (Budesonide Turbuhaler) monotherapy in pediatric subjects with bronchial asthma (aged 5-15 years) who are ICS-naive and responding poorly to existing non-ICS therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Improvement in JPAC (Japanese Pediatric Asthma Control Program) score

Key secondary outcomes

- Respiratory function
- Parent/guardian satisfaction
- Adherence
- Fractional exhaled nitric oxide
- Adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Budosonide turbuhaler (200 mcg) 1 inhlation, Twice daily, 12 weeks

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

Age-lower limit

5

years-old

<=

Age-upper limit

15

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Outpatients with bronchial asthma aged between 5 and 15 years
(2) Patients for whom both patient's and parent/guardian's written informed consent can be obtained
Note: For patients who are too young to provide written informed consent, verbal assent of the patients confirmed by parent/guardian can be substituted.
(3) Patients who have not received ICS therapy during the preceding three months
(4) Patients with asthma poorly controlled over the preceding month (with a total JPAC score of 11 or less at the start of study) (including newly diagnosed patients)

Key exclusion criteria

(1) Patients given systemic steroid therapy within the preceding month
(2) Patients unable to use Turbuhaler appropriately (judgment by physician)
(3) Patients contraindicated for the study drug
(4) Patients with any chronic respiratory disease other than asthma
(5) Patients complicated by acute lower respiratory tract infection at the time of enrollment
(6) Other patients judged by the physician to be inappropriate for this study

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Shigemi Yoshihara

Organization

Dokkyo Medical University

Division name

Department of Pediatrics

Zip code

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi

TEL

0282-86-1111

Email

Name of contact person

1st name
Middle name
Last name	Shigemi Yoshihara

Organization

Dokkyo Medical University

Division name

Department of Pediatrics

Zip code

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi

TEL

0282-86-1111

Homepage URL

Email

Institute

J-TRUST Study Group

Institute

Department

Personal name

Organization

Japan Allergy Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

獨協医科大学（栃木県）
医療法人ありた小児科・アレルギー科クリニック（広島県）
重田こども・アレルギークリニック（群馬県）
清水小児科アレルギークリニック（埼玉県）
せきねこどもクリニック（千葉県）
土田こどもクリニック（北海道）
にしかわクリニック（香川県）
国立病院機構 下志津病院（千葉県）
同愛記念病院（東京都）
医療法人土屋小児病院（埼玉県）
わたなべ小児科・アレルギー科クリニック（北海道）
西方病院（栃木県）
大田原赤十字病院（栃木県）

Date of disclosure of the study information

2011

Year

03

Month

01

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

2010

Year

12

Month

05

Day

Date of IRB

Anticipated trial start date

2011

Year

03

Month

01

Day

Last follow-up date

2012

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

02

Month

28

Day

Last modified on

2012

Year

09

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006122