UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011853
Receipt number R000013856
Scientific Title Clinical study concerning anti-inflammatory effect of fixed dose therapy by budesonide/formoterol combination inhaler for moderate persistent asthmatics.
Date of disclosure of the study information 2013/09/25
Last modified on 2013/09/24 21:23:55

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Basic information

Public title

Clinical study concerning anti-inflammatory effect of fixed dose therapy by budesonide/formoterol combination inhaler for moderate persistent asthmatics.

Acronym

anti-inflammatory effect of BUD/FM inhaler

Scientific Title

Clinical study concerning anti-inflammatory effect of fixed dose therapy by budesonide/formoterol combination inhaler for moderate persistent asthmatics.

Scientific Title:Acronym

anti-inflammatory effect of BUD/FM inhaler

Region

Japan


Condition

Condition

Bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the long-term airway anti-inflammatory effect of fix-dosed maintenance therapy with budesonide/formoterol combination inhaler with other treatment including ICS alone or salmeterol/fluticasone

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

FeNO, as a marker of airway inflammation

Key secondary outcomes

asthma control test (ACT) score, and the number of SABA use


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Budesonide/formoterol(BUD/FM)

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

The asthmatics treated for at least 6 months with SFC250 2 puffs/day or BUD 800 micro-g + SLM 100 micro-g /day treatment in whom well-controlled status were maintained

Key exclusion criteria

Current smokers, those who had a smoking history (smoking index > 400) and patients with suspected COPD were excluded

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayuki Hojo

Organization

National Center for Global Health and Medicine

Division name

Devision of Respiratory Medicine

Zip code


Address

Toyama1-21-1, Shinjuku, Tokyo, Japan 162-8655

TEL

03-3202-7181

Email

mhojo@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masayuki Hojo

Organization

National Center for Global Health and Medicine

Division name

Devision of Respiratory Medicine

Zip code


Address

Toyama1-21-1, Shinjuku, Tokyo, Japan 162-8655

TEL

03-3202-7181

Homepage URL


Email

mhojo@hosp.ncgm.go.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

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

国立国際医療研究センター(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


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 03 Month 10 Day

Date of IRB


Anticipated trial start date

2010 Year 03 Month 15 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

2013 Year 09 Month 24 Day

Last modified on

2013 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013856


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name