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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003403
Receipt No. R000004126
Scientific Title Additional effects of moderate-dose fluticasone and salmeterol combination therapy on exacerbations and airflow limitations in patients with COPD in Japan
Date of disclosure of the study information 2010/04/01
Last modified on 2017/10/03

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Basic information
Public title Additional effects of moderate-dose fluticasone and salmeterol combination therapy on exacerbations and airflow limitations in patients with COPD in Japan
Acronym Additional effects of SFC in patients with COPD
Scientific Title Additional effects of moderate-dose fluticasone and salmeterol combination therapy on exacerbations and airflow limitations in patients with COPD in Japan
Scientific Title:Acronym Additional effects of SFC in patients with COPD
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate that moderate-dose (500mcg/day) fluticasone and salmeterol combination therapy prevents exacerbation and airflow limitation in Japanese patients with COPD, a randomized, parallel-group, open label trial is conducted.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevent the numbers and severity of exacerbation/yr/patient
Key secondary outcomes Prevent the decline of FEV1

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Add on treatment with inhaled 250mcg dose of SFC (twice daily), everyday, for 3years
Interventions/Control_2 control
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria COPD
Key exclusion criteria 1. other respiratory diseases
2. regular use of inhaled corticosteroids
3. regular use of inhaled and transdermal beta2 agonists
4. severe other orgen diseases
5. active malignancies
Target sample size 1008

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisamichi Aizawa
Organization Kurume University School of Medicine
Division name Department of Medicine, Division of Respirology, Neurology, and Rheumatology
Zip code
Address 67 Asahimachi, Kurume, Fukuoka, Japan
TEL 0942-31-7560
Email kawayama_tomotaka@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazako Matsunaga
Organization Kurume University School of Medicine
Division name Department of Medicine, Division of Respirology, Neurology, and Rheumatology
Zip code
Address 67 Asahimachi, Kurume
TEL 0942-31-7560
Homepage URL
Email kmatsunaga@med.kurume-u.ac.jp

Sponsor
Institute Kyusyu Asthma & COPD Forum
Institute
Department

Funding Source
Organization KASCOM
Organization
Division
Category of Funding Organization Other
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 04 Month 01 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 Terminated
Date of protocol fixation
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 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 03 Month 29 Day
Last modified on
2017 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004126

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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