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Recruitment status Completed
Unique ID issued by UMIN UMIN000012189
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Middle name
Last name Kobayashi
Organization Saitama Medical University Hospital
Division name Department of General Internal Medicine
Zip code
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
Middle name
Last name Kobayashi
Organization Saitama Medical University Hospital
Division name Department of General Internal Medicine
Zip code
Address 38 Morohongo Moroyamamachi Irumagun Saitama, Japan
TEL 049-276-1667
Homepage URL
Email kobatake@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
Results
Compared with the ICS alone increase group, the ICS combination group further improves the eosinophilic inflammation of the respiratory tract.
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
2012 Year 04 Month 01 Day
Date of IRB
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014248


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