UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028408
Receipt number R000021136
Scientific Title Drug adherence and objective index in childhood asthma
Date of disclosure of the study information 2017/07/27
Last modified on 2017/07/27 17:03:42

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Basic information

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

Condition

Bronchial Asthma

Classification by specialty

Pneumology Clinical immunology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

National Hospital Organization Sagamihara National Hospital

Institute

Department

Personal name



Funding Source

Organization

Environmental Restoration and Conservation Agency

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

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


Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 27 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

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

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.


Management information

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name