UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007708 |
|---|---|
| Receipt number | R000009083 |
| Scientific Title | Evaluation of the efficacy of Symbicort turbuhaler that target patients with bronchial ashtma complicated by COPD and bronchial asthma - Evaluation of diurnal variation in peak flow - |
| Date of disclosure of the study information | 2012/04/10 |
| Last modified on | 2012/04/09 19:09:39 |
* 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
Evaluation of the efficacy of Symbicort turbuhaler that target patients with bronchial ashtma complicated by COPD and bronchial asthma - Evaluation of diurnal variation in peak flow -
Acronym
Evaluation of the efficacy of Symbicort turbuhaler that target patients with bronchial ashtma complicated by COPD and bronchial asthma - Evaluation of diurnal variation in peak flow -
Scientific Title
Evaluation of the efficacy of Symbicort turbuhaler that target patients with bronchial ashtma complicated by COPD and bronchial asthma - Evaluation of diurnal variation in peak flow -
Scientific Title:Acronym
Evaluation of the efficacy of Symbicort turbuhaler that target patients with bronchial ashtma complicated by COPD and bronchial asthma - Evaluation of diurnal variation in peak flow -
Region
| Japan |
Condition
Condition
bronchial asthma complicated by COPD and bronchial ashtma
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy of Symbicort turbuhaler for diurnal variation of respiratory function in patients with bronchial asthma complicated by COPD and bronchial asthma. We also examine whether Symbicort turbuhaler inhibit expiratory NO as indicator of respiratory inflammation and serum substance P as indicator of airway hyperresponsiveness.
Consider that there are some reports that Symbicort is equivalent to rapid-acting bronchodilator SABA, we examine whether bronchodilator effect of Symbicort is correlated with that of SABA by resiratory function test after those inhalation.
We eventually and comprehensively determine the phenotype that Symbicort is useful.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diurnal variation in PEF by Piko-1
Key secondary outcomes
expiratory NO
eosinophil in sputum
serum substance P
FEV1.0
FEV1.0 in five minites after inhalaton of Symbicort or Procaterol Hydrochloride
chest CT
assessment of safty
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
symbicort turbuhaler
for 2years
twice daily, 1-4 inhalation
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
>COPD (complicated by asthma) or asthma (unquestioned stage)
>patients who have inspiratory flow rate can be inhaled test drug
>patients who voluntary consent document was obtained after receiving a full explanation upon participation in this study and full understanding
>outpatients
Key exclusion criteria
>patient wiht an infection refractory to any antibiotics, or deep-seated mycoses
>hitory of hypersensitivity to test drug
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Tasumi |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of respirology
Zip code
Address
1-8-1 inohana, chuo-ku, chiba city, chiba prefecture
TEL
043-222-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Iesato |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of respirology
Zip code
Address
1-8-1 inohana, chuo-ku, chiba city, chiba prefecture
TEL
043-222-7171
Homepage URL
http://www.m.chiba-u.ac.jp/class/respir/index.html
iesato@gmail.com
Sponsor or person
Institute
Department of respirology, graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2012 | Year | 04 | Month | 10 | 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
| 2010 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 09 | Day |
Last modified on
| 2012 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009083
