UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000366 |
|---|---|
| Receipt number | R000000456 |
| Scientific Title | Multicentric study of inhaled corticosteroid and theophylline in asthma |
| Date of disclosure of the study information | 2006/04/01 |
| Last modified on | 2008/12/08 20:32:29 |
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Basic information
Public title
Multicentric study of inhaled corticosteroid and theophylline in asthma
Acronym
Inhaled corticosteroid and theophylline in asthma
Scientific Title
Multicentric study of inhaled corticosteroid and theophylline in asthma
Scientific Title:Acronym
Inhaled corticosteroid and theophylline in asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of combination therapy of inhaled corticosteroid and theophylline among smoking and non-smoking bronchial asthma patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morning peakflow
Key secondary outcomes
Evening peakflow
Spirogram
Blood concentration of theophylline
Induced sputum
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
Combination therapy of inhaled corticosteroid and oral theophylline
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Bronchilal asthma patients, aged 20 to 70, smoker and non smoker, inhaled corticosteroid use=>1 month, theophylline free=> 1 month.
Smoker means a current smoker who continues to smoke after steady instructions of smoking cessation.
Non-smoker means a never smoker or an ex-smoker who stopped smoking more than 3 years ago and smoking index is less than 10 pack-years.
Patients who uses inhaled corticosteroid for more than 1 month.
Patients who have signed the agreement for participation in this study
Key exclusion criteria
Patients who used theophylline and oral or intravenous corticosteroid within 1 month,
Patients who had acute exacerbation of ashtma within 1 month.
Patients who cannot perform spirogram,
Patients with respiratory infection, glaucoma , or pepcic ulcer
In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Yokoyama |
Organization
Graduate school of biomedical sciences, Hiroshima university
Division name
Department of molecular and internal medicine
Zip code
Address
1-2-3 Kasumi Minami-ku Hirosima city 734-8551 Japan
TEL
082-257-5196
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Haruta |
Organization
Graduate school of biomedical sciences, Hiroshima university
Division name
Department of molecular and internal medicine
Zip code
Address
1-2-3 Kasumi Minami-ku Hirosima city 734-8551 Japan
TEL
082-257-5196
Homepage URL
Sponsor or person
Institute
Graduate school of biomedical sciences, Hiroshima university, department of molecular and internal medicine
Institute
Department
Personal name
Funding Source
Organization
Graduate school of biomedical sciences, Hiroshima university, department of molecular and internal medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2006 | Year | 04 | 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
Completed
Date of protocol fixation
| 2005 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 03 | Month | 24 | Day |
Last modified on
| 2008 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000456
