UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002719 |
|---|---|
| Receipt number | R000003276 |
| Scientific Title | Comparison of the effect of SFC (Salmeterol Fluticasone Combination) and ICS plus Tulobuterol Patch in asthma : multicenter open-labelled double cross over study |
| Date of disclosure of the study information | 2009/11/06 |
| Last modified on | 2010/05/18 21:24:24 |
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Basic information
Public title
Comparison of the effect of SFC (Salmeterol Fluticasone Combination) and ICS plus Tulobuterol Patch in asthma : multicenter open-labelled double cross over study
Acronym
Comparison of the effect of SFC (Salmeterol Fluticasone Combination) and ICS plus Tulobuterol Patch in asthma : double cross over study
Scientific Title
Comparison of the effect of SFC (Salmeterol Fluticasone Combination) and ICS plus Tulobuterol Patch in asthma : multicenter open-labelled double cross over study
Scientific Title:Acronym
Comparison of the effect of SFC (Salmeterol Fluticasone Combination) and ICS plus Tulobuterol Patch in asthma : double cross over study
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is a prospective open-labelled trial of double crossover design comparing the effects of treatment with SFC (Salmeterol Fluticasone Combination) and
ICS plus Tulobuterol Patch .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Mean variation of morning PEF
Key secondary outcomes
Pulmonary function (FEV1, V 50,V25)
Asthma Control Test
Patient questionnaire
Mean variation of evening PEF
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The first 4week are treated with SFC.
The second 4week are treated with ICS plus Tulobuterol Patch.
The third 4week are treated with SFC.
Interventions/Control_2
The first 4week are treated with ICS plus Tulobuterol Patch.
The second 4week are treated with SFC.
The third 4week are treated with ICS plus Tulobuterol Patch.
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
Patients diagnosed with asthma and who meet following requirements
1) patient receiving SFC or ICS+ TP
(without regard to other drugs)
2) patient can write down the patient-dairy of this study appropriately from the doctor's viewpoint
3) patient can understand how to use PEF-meter and use appropriately from the doctor's viewpoint
4) patient can keep the rule of this study and doctor's direction from the doctor's viewpoint
5) obtain informed consent before registration to this study
6) Patient aged 20 years and above when doctors obtain informed consent
Key exclusion criteria
1) severe asthma like following examples
patients with a past history of asthma
attack with airway cannulation or respiratory arrest , CO2 excess symptom, hypoxic convulsion , syncope
patients receiving steroid injection or ACTH injection during 4 weeks before registration to this study
patients receiving oral steroid or beta2 agonist injection , xanthene injection during 4 weeks before registration to this study
2) patient suspected of infection which has no effective antibacterial drug or deep mycosis
3) uncontrolled diabetes mellitus , hypertension , cardiac disease or hyperthyroidism
4) tuberculosis or respiratory infection
5) patient experienced adverse effect by components of study drug or another inhaled powder medicine
6) patients who is pregnant or suspected of pregnancy , wish to get pregnant , nursing mom
7) patients who don't have ability to agree
8) inappropriate patient for this study from the doctor's viewpoint
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Tanijiri |
Organization
Kansai Medical University HirakataHospita
Division name
Respiratory medicine
Zip code
Address
2-3-1shinmachi,hirakata,osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kansai Medical University HirakataHospital
Division name
Respiratory medicine
Zip code
Address
2-3-1shinmachi,hirakata,osaka
TEL
Homepage URL
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2009 | Year | 11 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | 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
| 2009 | Year | 11 | Month | 06 | Day |
Last modified on
| 2010 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003276
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
