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

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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 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


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

Value
https://center6.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