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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000983
Receipt No. R000001155
Scientific Title Open-label, single-center, randamized and parallel-group study to compare the effect of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and that of fluticasone propionate dry powder inhaler (FP-DPI) on large and small airways involvement in bronchial asthma.
Date of disclosure of the study information 2008/01/13
Last modified on 2010/02/19

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Basic information
Public title Open-label, single-center, randamized and parallel-group study to compare the effect of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and that of fluticasone propionate dry powder inhaler (FP-DPI) on large and small airways involvement in bronchial asthma.
Acronym Study to compare the effect of HFA-BDP and FP-DPI in bronchial asthma.
Scientific Title Open-label, single-center, randamized and parallel-group study to compare the effect of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and that of fluticasone propionate dry powder inhaler (FP-DPI) on large and small airways involvement in bronchial asthma.
Scientific Title:Acronym Study to compare the effect of HFA-BDP and FP-DPI 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 fluticasone propionate dry powder inhaler on large and small airways involvement in bronchial asthma using impulse oscillometry, chest computed tomography, continuous methacholine inhalation method, health related quality of life questionnaires, etc.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Parameters of impulse oscillometry at 0, 4, 8 and 12 weeks.
Indices of chest computed tomography at 0 and 12 weeks.
Indices of continuous methacholine inhalation method at 0 and 12 weeks.
Key secondary outcomes 1 Values of pulmonary function at 0, 4, 8 and 12 weeks.
2 Inflammatory biomarkers of induced sputum at 0 and 12 weeks.
3 Exhaled nitric oxide concentration at 0 and 12 weeks.
4 Scores of questionnaires at 0 and 12 weeks.
5 Wheezing on auscultation at 0, 4, 8 and 12 weeks.

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 bid
12 weeks
Interventions/Control_2 Fluticasone propionate dry powder inhaler 200 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 smokers
2 Past treatment with inhaled corticosteroids ever
3 Past treatment with oral corticosteroids in the previous 2 months
4 Intractable infection such as systemic fungal infection
5 Allergy to the drugs used in this study
6 Tuberculosis or other respiratory infection
7 Obstructive lung disease such as COPD or bronchiectasis
8 Adrenal insufficiency
9 Dependency on systemic steroids
10 Glaucoma or cataract
11 Pregnancy or lactation
12 Inappropriate patients from the doctor's viewpoint
Target sample size 60

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, Japan.
TEL 075-751-3830
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoshi Takeda
Organization Kyoto University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan.
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
2008 Year 01 Month 13 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
2007 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2009 Year 10 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
2008 Year 01 Month 13 Day
Last modified on
2010 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001155

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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