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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001983
Receipt No. R000002182
Scientific Title Efficacy of Pranlukast on Stepped Down Treatment for well-controlled patients with mild persistent asthma.
Date of disclosure of the study information 2009/05/19
Last modified on 2016/02/22

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Basic information
Public title Efficacy of Pranlukast on Stepped Down Treatment for well-controlled patients with mild persistent asthma.
Acronym Efficacy of Pranlukast on Stepped Down Treatment for well-controlled patients with mild persistent asthma.
Scientific Title Efficacy of Pranlukast on Stepped Down Treatment for well-controlled patients with mild persistent asthma.
Scientific Title:Acronym Efficacy of Pranlukast on Stepped Down Treatment for well-controlled patients with mild persistent asthma.
Region
Japan

Condition
Condition asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compair whether patients with asthma that is well-controlled with the use of 200 mcg/day of inhaled corticosteroids can recieve a step-down treatment with pranlukast or 100 mcg/day of inhaled corticosteroids.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes symptom status of asthma
Key secondary outcomes pulmonary function and status of airway inflammation after 2, 4, 6 months treatment period

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pranlukast, 450mg/day, 6months
Interventions/Control_2 inhaled corticosteroid, 100mcg/day, 6months
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with mild persistent asthma who are well-controlled for at least last 3 months
Key exclusion criteria 1. under 20 years old
2. additional usage of other drugs provided in protocol
3. patients for contraindication
4. patients with malignant tumor
5. pregnant women
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kazuhisa Takahashi
Organization Juntendo University school of medicine
Division name Department of respiratory medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5802-1063
Email kztakaha@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Atsuta
Organization Juntendo University school of medicine
Division name Department of respiratory medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5802-1063
Homepage URL
Email atsuta@juntendo.ac.jp

Sponsor
Institute Juntendo University school of medicine, Department of respiratory medicine
Institute
Department

Funding Source
Organization none
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 順天堂大学医学部附属順天堂医院呼吸器内科

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.tandfonline.com/doi/abs/10.3109/02770903.2015.1087556?journalCode=ijas20
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 Completed
Date of protocol fixation
2009 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 12 Month 26 Day
Date of closure to data entry
2013 Year 05 Month 29 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 19 Day
Last modified on
2016 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002182

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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