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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009990
Receipt No. R000011695
Scientific Title Comparison of Clinical Effects of Salmeterol/Fluticasone Propionate Combination Products Delivered via Metered-Dose Inhaler with Dry Powder Inhaler in Patients with Moderate Asthma
Date of disclosure of the study information 2013/02/08
Last modified on 2014/08/13

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Basic information
Public title Comparison of Clinical Effects of Salmeterol/Fluticasone Propionate Combination Products Delivered via Metered-Dose Inhaler with Dry Powder Inhaler in Patients with Moderate Asthma
Acronym SFC Diskus vs aerosol inhaler
Scientific Title Comparison of Clinical Effects of Salmeterol/Fluticasone Propionate Combination Products Delivered via Metered-Dose Inhaler with Dry Powder Inhaler in Patients with Moderate Asthma
Scientific Title:Acronym SFC Diskus vs aerosol inhaler
Region
Japan

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

Objectives
Narrative objectives1 To compare the clinical effects of SFC dry powder products (Diskus) and those of aerosol products in the viewpoint of peripheral airway inflammation in adult asthmatic patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Respiratory resistance and reactance measured by Forced Oscillation Technique (Most Graph)
Key secondary outcomes FeNO
Asthma Control Test score
Side effect

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
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 SFC Diskus; wash out; SFC aerosol
Interventions/Control_2 SFC aerosol; wash out; SFC Diskus
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 moderate persistent adult asthmatics who had received ICS or ICS/LABA combination inhaler of fluticasone 500 micro-g equivalent daily or less and under well-control status have been recruited.
Key exclusion criteria Current smokers, those who had pulmonary diseases with non reversible airflow obstruction such as COPD or pulmonary fibrosis were excluded.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Hojo
Organization National Center for Global Health and Medicine
Division name Devision of Respiratory Medicine
Zip code
Address Toyama1-21-1, Shinjuku, Tokyo, Japan 162-8655
TEL 03-3202-7181
Email mhojo@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nahoko Sato
Organization National Center for Global Health and Medicine
Division name Devision of Respiratory Medicine
Zip code
Address Toyama1-21-1, Shinjuku, Tokyo, Japan 162-8655
TEL 03-3202-7181
Homepage URL
Email nahoko.t.k.d@gmail.com

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
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 国立国際医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 08 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 Completed
Date of protocol fixation
2013 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 12 Day
Last follow-up date
2013 Year 07 Month 27 Day
Date of closure to data entry
2013 Year 07 Month 27 Day
Date trial data considered complete
2013 Year 07 Month 27 Day
Date analysis concluded
2013 Year 07 Month 27 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 07 Day
Last modified on
2014 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011695

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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