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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006589
Receipt No. R000007799
Scientific Title Investigation of inhaled Salmeterol/ Fluticasone propionate (SFC) in patient with COPD.
Date of disclosure of the study information 2011/10/24
Last modified on 2014/03/23

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Basic information
Public title Investigation of inhaled Salmeterol/ Fluticasone propionate (SFC) in patient with COPD.
Acronym SFC for COPD
Scientific Title Investigation of inhaled Salmeterol/ Fluticasone propionate (SFC) in patient with COPD.
Scientific Title:Acronym SFC for COPD
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness and safety of inhaled Salmeterol/ Fluticasone propionate in patients with COPD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Changes of FEV1
Key secondary outcomes QOL, Safety

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 Inhaled Salmeterol/ Fluticasone propionate 100 micro gram
Interventions/Control_2 Inhaled Salmeterol/ Fluticasone propionate 250 micro gram
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with chronic obstructive pulmonary disease
Patients can use the inhaled thearapy
Patients gave written informed consent
Key exclusion criteria History of hyper- sensitivity to Salmeterol/ Fluticasone propionate
Patients with bronchial asthma
Patients during acute exacerbation
Presence of infectious disease, pneumothorax, and severe heart failure
Target sample size 342

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal medicine
Zip code
Address 1-20-1, Handayama, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Yasui
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1, Handayama, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2263
Homepage URL
Email yassy19781119@yahoo.co.jp

Sponsor
Institute Hamamatsu University School of 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 浜松医科大学

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 24 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
2011 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 21 Day
Last modified on
2014 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007799

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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