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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000632
Receipt No. R000000766
Scientific Title Open-label, single-center, randomized and parallel-group study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate on small airways involvement in asthma assessed using impulse oscillometry system.
Date of disclosure of the study information 2007/03/09
Last modified on 2007/03/09

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Basic information
Public title Open-label, single-center, randomized and parallel-group study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate on small airways involvement in asthma assessed using impulse oscillometry system.
Acronym Controlled study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate in bronchial asthma.
Scientific Title Open-label, single-center, randomized and parallel-group study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate on small airways involvement in asthma assessed using impulse oscillometry system.
Scientific Title:Acronym Controlled study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate in bronchial asthma.
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and that of Chlorofluorocarbon beclomethasone dipropionate on small airways involvement in asthma with a use of impulse oscillometry system.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Parameters of impulse oscillometry system.
Key secondary outcomes 1 Symptoms
2 Wheezing on auscultation
3 Methacholine airway responsiveness
4 Pulmonary function
5 Lung volume measurement
6 Inflammatory biomarkers of induced sputum and peripheral blood
7 Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Hydrofluoroalkane-134a beclomethasone dipropionate 200 mcg bids
12 weeks
Interventions/Control_2 Chlorofluorocarbon dipropionate 400 mcg bid
12 weeks
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 Inhaled corticosteroids-naive mild-to-moderate asthmatic patients
Key exclusion criteria 1 Current smoker
2 Past treatment with inhaled corticosteroids
3 Receiving oral corticosteroids in the previous 2 months
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Niimi
Organization Kyoto University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3830
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Yamaguchi
Organization Kyoto University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3830
Homepage URL
Email

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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
2007 Year 03 Month 09 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
2005 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2005 Year 05 Month 01 Day
Last follow-up date
2006 Year 07 Month 01 Day
Date of closure to data entry
2006 Year 07 Month 01 Day
Date trial data considered complete
2006 Year 07 Month 01 Day
Date analysis concluded
2006 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 03 Month 09 Day
Last modified on
2007 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000766

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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