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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016933
Receipt No. R000019657
Scientific Title An Open-label Crossover Trial to Explore the Clinical Effects and Safety of As-needed Use of ICS/LABA in Patients with Mild-intermittent Asthma
Date of disclosure of the study information 2015/04/01
Last modified on 2015/09/28

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Basic information
Public title An Open-label Crossover Trial to Explore the Clinical Effects and Safety of As-needed Use of ICS/LABA in Patients with Mild-intermittent Asthma
Acronym Trial of As-needed use of ICS/LABA (TRAIL study)
Scientific Title An Open-label Crossover Trial to Explore the Clinical Effects and Safety of As-needed Use of ICS/LABA in Patients with Mild-intermittent Asthma
Scientific Title:Acronym Trial of As-needed use of ICS/LABA (TRAIL study)
Region
Japan

Condition
Condition Patinets with mild-intermittent asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the effect and the safety of as-needed use of ICS/LABA in patinets with mild-intermittent asthma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes duration until the first excerbation
Key secondary outcomes 1. numbers of exacerbation
2. FEV1

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 As-nneded use of ICS/LABA
Interventions/Control_2 standard treatment
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Asthma diagnosed by allergist
1. Age is 20 to 80 years old at the time of obtaining informed consent
2. Being treated regularly more than a year
3. No asthma symptom in last 3 months before the enrollment
4. Being able to understand the as-needed use of ICS/LABA
5. Being able to obtain informed consent
Key exclusion criteria 1. Pregnant woman or woman who wish to be pregnant during the trial
2. Cough variant asthma
3. Current smoker or ex-smoker who smoked more than 10 pack-year
4. Complications with pulmonary diseases such as COPD and heart diseases
5. Admission within an year due to asthma attack
6. Participating in clinical trials
7. Being determined not to have indication for entry by physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Tanaka
Organization Showa University, Department of Medicine
Division name Division of Allergy and Respiratory Medicine
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 81-3-3784-8532
Email tanakaa@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Tanaka
Organization Showa University, Department of Medicine
Division name Division of Allergy and Respiratory Medicine
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 81-3-3784-8532
Homepage URL
Email tanakaa@med.showa-u.ac.jp

Sponsor
Institute Showa University, Department of Medicine, Division of Allergy and Respiratory Medicine
Institute
Department

Funding Source
Organization Showa University, Department of Medicine, Division of Allergy and Respiratory Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 昭和大学病院

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2015 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 27 Day
Last modified on
2015 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019657

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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