UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012189
Receipt number R000014248
Scientific Title Advair Alvesco combination therapy:AVEC study
Date of disclosure of the study information 2013/10/31
Last modified on 2019/07/16 07:15:54

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Basic information

Public title

Advair Alvesco combination therapy:AVEC study

Acronym

Advair Alvesco combination therapy:AVEC study

Scientific Title

Advair Alvesco combination therapy:AVEC study

Scientific Title:Acronym

Advair Alvesco combination therapy:AVEC study

Region

Japan


Condition

Condition

bronchial asthma

Classification by specialty

Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The effectiveness of the combination therapy of an inhalational steroid varying in the particle size

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Improvement degree of the asthmatic control marker

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

one(ICS, inhaled corticosteroid)
three month, one year

Interventions/Control_2

two(ICS, inhaled corticosteroid)
three month, one year

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

bronchial asthma patient

Key exclusion criteria

Pregnant

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Takehito
Middle name
Last name Kobayashi

Organization

Saitama Medical University Hospital

Division name

Department of General Internal Medicine

Zip code

350-0495

Address

38 Morohongo Moroyamamachi Irumagun Saitama, Japan

TEL

049-276-1667

Email

kobatake@saitama-med.ac.jp


Public contact

Name of contact person

1st name Takehito
Middle name
Last name Kobayashi

Organization

Saitama Medical University Hospital

Division name

Department of General Internal Medicine

Zip code

350-0495

Address

38 Morohongo Moroyamamachi Irumagun Saitama, Japan

TEL

049-276-1667

Homepage URL


Email

kobatake@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University Hospital
allergy center

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

Saitama Medical University Hospital Hospital IRB

Address

38 Morohongo Moroyamamachi Irumagun Saitama, Japan

Tel

049-276-1354

Email

hirb@saitama-med.ac.jp


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

2013 Year 10 Month 31 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/31277957

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/31277957

Number of participants that the trial has enrolled

40

Results

Compared with the ICS alone increase group, the ICS combination group further improves the eosinophilic inflammation of the respiratory tract.

Results date posted

2019 Year 07 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 07 Month 10 Day

Baseline Characteristics

Asthmatic patients

Participant flow

Outpatient

Adverse events

nothing

Outcome measures

Eosinophil in sputum
asthma control test
Spirometry

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 04 Month 01 Day

Date of IRB

2011 Year 03 Month 31 Day

Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 10 Month 31 Day

Last modified on

2019 Year 07 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014248


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name