UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004097 |
|---|---|
| Receipt number | R000004931 |
| Scientific Title | Prospective combined analysis of spirometry, impulse oscillation, and chest tomography for the effect of salmeterol/fluticasone (SFC) in COPD |
| Date of disclosure of the study information | 2010/08/25 |
| Last modified on | 2021/10/16 20:36:21 |
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Basic information
Public title
Prospective combined analysis of spirometry, impulse oscillation, and chest tomography for the effect of salmeterol/fluticasone (SFC) in COPD
Acronym
Prospective analysis of spirometry and chest tomography for the effect of salmeterol/fluticazone (SFC) in COPD
Scientific Title
Prospective combined analysis of spirometry, impulse oscillation, and chest tomography for the effect of salmeterol/fluticasone (SFC) in COPD
Scientific Title:Acronym
Prospective analysis of spirometry and chest tomography for the effect of salmeterol/fluticazone (SFC) in COPD
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the new indicators for the effect on lung hyperinflation with treatment of SFC in COPD, using combined analysis of spirometry, oscillation, and chest tomography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
inspiratory capacity
Key secondary outcomes
1) subjective dyspnea
2)spirometry
3)R5, R20, R5-R20, and X5 on oscillation
4)Total lung capacity and emphysema lung volume on inspiratory phase expiratory phase by chest tomograpghy
5) subanalysis of lung hyperinflation and subjective dyspnea in both responder and non-responder for SFC
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SFC250 1 inhaler per time, twice a day
Interventions/Control_2
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. FEV1.0/FVC70%below after bronchodilator
2. not receiving any treatment of inhaled steroid, long-term b stimulant, and/or anti-cholinergic agent
Key exclusion criteria
1. any disease with possible air flow limitation defined as below
2.defined as below;
bronchial asthma, diffuse pan bronchitis, sinobronchial syndrome, bronchial ectasis, tuberculosis, pneumoconiosis, lymphangioleiomyomatosis, congestic heart failure, and interstitial pneumonia detected by chest Xray
3. contraindication to SFC treatment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Hasegawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
0527442167
yhasega@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Naozumi |
| Middle name | |
| Last name | Hashimoto |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
0527442167
Homepage URL
hashinao@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
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
Institutional Review Board
Address
65 Tsurumai Showa-ku Nagoya
Tel
0527412111
hashinao@med.nagoya-u.ac.jp
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
Immature result
Number of participants that the trial has enrolled
34
Results
The clinical trial was discontinued due to small numbers.
Results date posted
| 2020 | Year | 09 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
COPD
Participant flow
written informed consent
Adverse events
none
Outcome measures
The studu did not have any conclusion.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2010 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 25 | Day |
Last modified on
| 2021 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004931
