Unique ID issued by UMIN | UMIN000000983 |
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Receipt number | 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 22:06:35 |
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.
Study to compare the effect of HFA-BDP and FP-DPI in bronchial asthma.
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.
Study to compare the effect of HFA-BDP and FP-DPI in bronchial asthma.
Japan |
Bronchial asthma
Pneumology |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Phase IV
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.
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
Numbered container method
2
Treatment
Medicine |
Hydrofluoroalkane-134a beclomethasone dipropionate 200 mcg bid
12 weeks
Fluticasone propionate dry powder inhaler 200 mcg bid
12 weeks
20 | years-old | <= |
Not applicable |
Male and Female
Inhaled corticosteroids-naive mild-to-moderate asthmatic patients
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
60
1st name | |
Middle name | |
Last name | Akio Niimi |
Kyoto University Graduate School of Medicine
Department of Respiratory Medicine
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan.
075-751-3830
1st name | |
Middle name | |
Last name | Tomoshi Takeda |
Kyoto University Graduate School of Medicine
Department of Respiratory Medicine
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan.
075-751-3830
Kyoto University Graduate School of Medicine
Kyoto University Graduate School of Medicine
Self funding
Japan
None
None
NO
2008 | Year | 01 | Month | 13 | Day |
Unpublished
Completed
2007 | Year | 01 | Month | 09 | Day |
2008 | Year | 02 | Month | 01 | Day |
2009 | Year | 10 | Month | 01 | Day |
2008 | Year | 01 | Month | 13 | Day |
2010 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001155
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