UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004196 |
|---|---|
| Receipt number | 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 12:35:42 |
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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
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
m-mine@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine, Division of Respiratory and Infectious Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005041
