UMIN-CTR Clinical Trial

Public title

Drug adherence and objective index in childhood asthma

Acronym

Drug adherence to asthma therapy and objective index

Scientific Title

Drug adherence and objective index in childhood asthma

Scientific Title:Acronym

Drug adherence to asthma therapy and objective index

Region

Japan

Condition

Bronchial Asthma

Classification by specialty

Pneumology	Clinical immunology	Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the relationship between
drug adherence and objective indices
(Spirometry, bronchodilator response, exhaled NO, Forced Oscillation Technique) in childhood asthma.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Patients will be divided into 2 groups, where drug adherence rate is more than 70% or less than 70%, and the following objective index will be compared between them.
1.The parameters of spirometry
2.Bronchodilator response

Key secondary outcomes

1.Comparison of adherence between
self-report and the remaining number of a dose counter
2. Compare following indices between 2groups.
a)Exhaled NO
b)The airway resistance with Forced Oscillation Technique
3.Reevaluation of the objective indices in the group whose drug adherence rate was less than 70% three months later.
The majority of them had received education on the role of inhaled steroids and confirmation of effective inhaler technique.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

7

years-old

<=

Age-upper limit

18

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients who have inhaled
corticosteroids or
corticosteroids-long-acting beta-2 adrenergic agonist combinations using a device with a dose counter.

Key exclusion criteria

1) It is impossible to measure lung function.
2) Patient has had an attack that required the inhalation of beta-2 adrenergic agonists to relieve symptoms within 2 weeks prior to the start of the trial.
3) Patients who did not agree to
participate in the study.
4) The subject is deemed inappropriate for this study, as judged by a medical doctor.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Motohiro Ebisawa

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Allergy, Clinical Research Center for Allergy and Rheumatology

Zip code

Address

18-1, Sakuradai, Minami-ku, Sagamiharashi, Kanagawa, Japan, 252-0392.

TEL

042-742-8311

Email

foodallergy@sagamihara-hosp.gr.jp

Name of contact person

1st name
Middle name
Last name	Tetsuharu Manabe

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Pediatrics

Zip code

Address

18-1, Sakuradai, Minami-ku, Sagamiharashi, Kanagawa, Japan, 252-0392.

TEL

042-742-8311

Homepage URL

Email

t-manabe@sagamihara-hosp.gr.jp

Institute

National Hospital Organization Sagamihara National Hospital

Institute

Department

Personal name

Organization

Environmental Restoration and Conservation Agency

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

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

国立病院機構相模原病院 (神奈川県)
National Hospital Organization Sagamihara National Hospital (Kanagawa Prefecture)

Date of disclosure of the study information

2017

Year

07

Month

27

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

Open public recruiting

Date of protocol fixation

2015

Year

06

Month

01

Day

Date of IRB

Anticipated trial start date

2015

Year

06

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Comparison of adherence between
self-report and the remaining number of a dose counter
2. Compare following indices between
2groups.
a) Exhaled NO
b) The airway resistance with Forced Oscillation Technique
3.Reevaluation of the objective indices in the group whose drug adherence rate was less than 70% three months later.
The majority of them had received education on the role of inhaled steroids and confirmation of effective inhaler technique.

Registered date

2017

Year

07

Month

27

Day

Last modified on

2017

Year

07

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021136