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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028408
Receipt No. 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

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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
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

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
URL(English) https://upload.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


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