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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003023
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hiroshima Allergy Research Group
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003123

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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