UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003023 |
|---|---|
| Receipt number | R000003123 |
| Scientific Title | Efficacy and safety of step-down therapy with ciclesonide once-daily and beta2-agonist tulobuterol patch in asthma patients receiving salmeterol/fluticasone propionate diskus: multicenter study |
| Date of disclosure of the study information | 2010/01/13 |
| Last modified on | 2010/01/13 12:09:46 |
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Basic information
Public title
Efficacy and safety of step-down therapy with ciclesonide once-daily and beta2-agonist tulobuterol patch in asthma patients receiving salmeterol/fluticasone propionate diskus: multicenter study
Acronym
Efficacy and safety of step-down therapy with ciclesonide once-daily and beta2-agonist tulobuterol patch in asthma patients receiving salmeterol/fluticasone propionate diskus
Scientific Title
Efficacy and safety of step-down therapy with ciclesonide once-daily and beta2-agonist tulobuterol patch in asthma patients receiving salmeterol/fluticasone propionate diskus: multicenter study
Scientific Title:Acronym
Efficacy and safety of step-down therapy with ciclesonide once-daily and beta2-agonist tulobuterol patch in asthma patients receiving salmeterol/fluticasone propionate diskus
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of step-down therapy with ciclesonide once-daily and beta2-agonist tulobuterol patch in asthma patients receiving salmeterol/fluticasone propionate diskus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
percentage of patients with reducing treatment and maintaining control of asthma
Key secondary outcomes
1)pulmonary function using spirometry
2)questionnaire of asthma control
3)questionnaire of adverse effects
4)impulse oscillation system parameters and exhaled nitric oxide (only 2 ceters)
5)adverse events
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
Patients whose asthma was controlled with salmeterol/fluticasone(low or moderate dose) for at least 3 months,are switched to step-down treatment with ciclesonide and tulobuterol patch. If the asthma is well controlled,physicians can reduce tulobuterol pathch during 6 months to aim at ciclesonide alone.
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
In patients with bronchial asthma (or cough variant asthma), all of the following criteria was required for enrollment :
1) age;20 years or more
2) receiving low or medium dose salmeterol/fluticasone propionate diskus for at least 3 months, and ACT total score =20 or >20 at baseline
3) no use of oral corticosteroids or systemic rescue medication within previous 3 months
4) little or nothing of asthma symptoms within previous 3 months
5) use of 2 times or less per 2 weeks of short-acting beta2-agonist within previous 1 month
6) Written informed consent from the patients
Key exclusion criteria
1)addition or dose-change of antiasthma medications (except for salmeterol/fluticasone propionate diskus) within previous 3 months
2)use of ciclesonide and beta2-agonist tulobuterol patch within previous 3 months
3)corresponding to contraindication on accompanied note of study medication
4)difficult to answer of self administered questionnaire
5)physician decided the patient is unsuitable to enrollment
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Haruta |
Organization
Hiroshima University Hospital
Division name
Department of respiratory medicine
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Miyamoto |
Organization
Hiroshima University Hospital
Division name
Department of respiratory medicine
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL
Homepage URL
Sponsor or person
Institute
Hiroshima Allergy Research Group
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
| 2010 | Year | 01 | Month | 13 | 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 | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | 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
| 2010 | Year | 01 | Month | 13 | Day |
Last modified on
| 2010 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003123
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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