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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007708
Receipt No. 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

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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
Email

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
Email iesato@gmail.com

Sponsor
Institute Department of respirology, graduate School of Medicine, Chiba University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009083

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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