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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004196
Receipt No. R000005041
Scientific Title Assessments of the effect of Salmeterol and Fluticasone Propionate (SFC250) on the patients with chronic obstructive pulmonary disease by Impulse Oscillometry
Date of disclosure of the study information 2010/09/13
Last modified on 2014/09/13

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Basic information
Public title Assessments of the effect of Salmeterol and Fluticasone Propionate (SFC250) on the patients with chronic obstructive pulmonary disease by Impulse Oscillometry
Acronym Assessments of the effect of Salmeterol and Fluticasone Propionate (SFC250) on the patients with chronic obstructive pulmonary disease
Scientific Title Assessments of the effect of Salmeterol and Fluticasone Propionate (SFC250) on the patients with chronic obstructive pulmonary disease by Impulse Oscillometry
Scientific Title:Acronym Assessments of the effect of Salmeterol and Fluticasone Propionate (SFC250) on the patients with chronic obstructive pulmonary disease
Region
Japan

Condition
Condition Chronic Obstructive Pulmonary Disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the additive effects of SFC250 on pulmonary functions of COPD patients treated by tiotropium
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To assess the additive effects of SFC250 on pulmonary functions (IOS, etc) of COPD patients treated by tiotropium on 4, 8,12weeks
Key secondary outcomes a) Improvement of clinical symptoms (dyspnea, cough, sputum) and QOL
b) Reduction of the exacerbations (follow up to 52weeks)
c) Adverse events

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Salmeterol and fluticasone propionate (25/250), 1 puff twice daily.
Interventions/Control_2 Control(continue treatment without SFC)
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 1. Patient is able to read and understand the Informed Consent Form and he/she will sign the Informed Consent.
2. COPD patient, in the age range of 40-80 years, meets all of the following inclusion criteria.
FEV1 < 80% of predicted value
Current or former smokers with at least 10 pack years smoking history
Patient is able to use Diskus.
Patient is already treated with tiotropium
Patient has COPD symptoms in spite of tiotropium treatment
Key exclusion criteria 1. Patient is receiving inhaled steroids and long-acting beta2-agonists.
2. Patient is diagnosis as asthma.
3. Patient is decided as inappropriate for this study by the investigator.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masamichi Mineshita
Organization St.Marianna University School ofMedicine
Division name Division of Respiratory and Infectious diseases
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa, Japan
TEL 044-977-8111
Email m-mine@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masamichi Mineshita
Organization St.Marianna University School ofMedicine
Division name Division of Respiratory and Infectious diseases
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki City
TEL 044-977-8111
Homepage URL
Email m-mine@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine, Division of Respiratory and Infectious Diseases
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

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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
2010 Year 09 Month 13 Day
Last modified on
2014 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005041

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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