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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019965
Receipt No. R000014605
Scientific Title Airway anti-inflammatory effect can be maintained after salmeterol/fluticasone combination inhaler therapy is stepped down from medium to low dose for mild to moderate persistent asthmatics
Date of disclosure of the study information 2015/11/28
Last modified on 2019/09/12

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Basic information
Public title Airway anti-inflammatory effect can be maintained after salmeterol/fluticasone combination inhaler therapy is stepped down from medium to low dose for mild to moderate persistent asthmatics
Acronym Anti-inflammatory effect after SFC step down
Scientific Title Airway anti-inflammatory effect can be maintained after salmeterol/fluticasone combination inhaler therapy is stepped down from medium to low dose for mild to moderate persistent asthmatics
Scientific Title:Acronym Anti-inflammatory effect after SFC step down
Region
Japan

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

Objectives
Narrative objectives1 To compare the airway anti-inflammatory effect of salmeterol/fluticasone combination inhaler between continuation therapy with SFC250 and step down therapy with SFC100
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The change of FeNO value after 1 year treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 To continue 1 year treatment with SFC250 or
Interventions/Control_2 To receive step down treatment with SFC100
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 The asthmatics treated for at least 6 months with SFC 250 Diskus 2 puffs daily therapy, in whom the disease was well-controlled or totally controlled,i.e., an ACT score of 20-25 points, were eligible
Key exclusion criteria Current smokers, those who had a smoking history (smoking index > 400) and patients with suspected COPD were excluded
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Hojo
Organization National Center for Global Health and Medicine
Division name Division of Respiratory Medicine
Zip code 1628655
Address 1-21-1Toyama, Shinjuku-ku, Tokyo, Japan 1628655
TEL 03-3202-7181
Email mhojo@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Hojo
Organization National Center for Global Health and Medicine
Division name Division of Respiratory Medicine
Zip code 1628655
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan 1628655
TEL 03-3202-7181
Homepage URL
Email mhojo@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center for Global Health and Medicine
Address 1-21-1Toyama,Shinjuku-ku,Tokyo,Japan
Tel 03-3202-7181
Email rinrijm@hosp.ncgm.go.jp

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

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 28 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 25
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
2013 Year 12 Month 02 Day
Date of IRB
2013 Year 12 Month 02 Day
Anticipated trial start date
2013 Year 12 Month 03 Day
Last follow-up date
2018 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 27 Day
Last modified on
2019 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014605

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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