UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002719
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Kansai Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003276

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.