UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003745
Receipt number R000004536
Scientific Title Clinical effects of budesonide/formoterol in patients with asthma
Date of disclosure of the study information 2010/06/14
Last modified on 2012/05/24 16:19:52

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Basic information

Public title

Clinical effects of budesonide/formoterol in patients with asthma

Acronym

Clinical effects of budesonide/formoterol in patients with asthma

Scientific Title

Clinical effects of budesonide/formoterol in patients with asthma

Scientific Title:Acronym

Clinical effects of budesonide/formoterol in patients with 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 budesonide/formoterol on clinical index of asthma compared with budesonide

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Indices of chest CT

Key secondary outcomes

Parameters of pulmonary function
PEF
Cell counts of induced sputum
Scores of quality of life


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Symbicort treatment group
Symicort turbuhaler (60) 2 inhlation, twice daily
Treatment period 4 months

Interventions/Control_2

Budosonide treatment group
Budosonide turbuhaler (200) 2 inhlation, twice daily
Treatment period 4 months

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

1. Patients who have been not treated with ICS or oral corticosteroids within 2 months before the study
2. Patients who have been not treated with LABA within 1 months before the study
3. Patients have typical asthma symptoms as follows; cough, wheeze, dyspnea, nocturnal sleep disturbance

Key exclusion criteria

1. Patients who have any coexisting pulmonary diseases other than asthma
2. Pregnancy or lactation
3. Patients have hypersensitivity to symbicort or budesonide
4. Patiesnts judged to be unsuitable by the doctors

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Hoshino

Organization

Atami Hospital
International University of Health and Welfare

Division name

Department of Respiratory Medicine

Zip code


Address

13-1 Higashikaigan-cho, Atami, Shizuoka

TEL

0557-81-9171

Email



Public contact

Name of contact person

1st name
Middle name
Last name Makoto Hoshino

Organization

Atami Hospital International University of Health and Welfare

Division name

Department of Respiratory Medicine

Zip code


Address

13-1 Higashikaigan-cho, Atami, Shizuoka

TEL

0557-81-9171

Homepage URL


Email



Sponsor or person

Institute

Atami Hospital International University of Health and Welfare

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

国際医療福祉大学熱海病院(静岡県)
Atami Hospital International University of Health and Welfare


Other administrative information

Date of disclosure of the study information

2010 Year 06 Month 14 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

2010 Year 04 Month 30 Day

Date of IRB


Anticipated trial start date

2010 Year 06 Month 01 Day

Last follow-up date

2012 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 06 Month 13 Day

Last modified on

2012 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004536


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name