UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002657 |
|---|---|
| Receipt number | R000003233 |
| Scientific Title | Effect of double inhaled corticosteroids in patients with moderate bronchial asthma |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2009/10/22 13:11:56 |
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Basic information
Public title
Effect of double inhaled corticosteroids in patients with moderate bronchial asthma
Acronym
Double inhaled corticosteroids on moderate bronchial asthma
Scientific Title
Effect of double inhaled corticosteroids in patients with moderate bronchial asthma
Scientific Title:Acronym
Double inhaled corticosteroids on moderate bronchial asthma
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare Adoair 500 micro g plus Asmanex 200 micro g and Adoair 1000 micro g in patients with uncontroled moderate bronchial asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
exhaled NO
Key secondary outcomes
pulmonary functions and peak flow
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adoair 500 micro g + Asmanex 200 micro g
Interventions/Control_2
Adoair 1000 micro g
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with uncontroled moderate asthma treated with Adoair 250 micro g twice a day.
Key exclusion criteria
Cronic disease such as COPD.
Acute disease such as infectious disease.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Kurashima |
Organization
Saitama cardiovascular and respiratory center
Division name
respiratory medicine
Zip code
Address
1696 Itai Kumagaya city, Saitama
TEL
048-536-9900
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Kurashima |
Organization
Saitama cardiovascular and respiratory center
Division name
respiratory medicine
Zip code
Address
1696 Itai Kumagaya city, Saitama
TEL
048-536-9900
Homepage URL
kurashima.kazuyoshi@pref.saitama.lg.jp
Sponsor or person
Institute
Saitama cardiovascular and respiratory center
Institute
Department
Personal name
Funding Source
Organization
Saitama cardiovascular and respiratory center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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
埼玉県立循環器・呼吸器病センター
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 22 | Day |
Last modified on
| 2009 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003233
