Unique ID issued by UMIN | UMIN000000632 |
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Receipt number | 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 15:34:21 |
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.
Controlled study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate in bronchial asthma.
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.
Controlled study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate in bronchial asthma.
Japan |
Bronchial asthma
Pneumology |
Others
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
Parameters of impulse oscillometry system.
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
Numbered container method
2
Treatment
Medicine |
Hydrofluoroalkane-134a beclomethasone dipropionate 200 mcg bids
12 weeks
Chlorofluorocarbon dipropionate 400 mcg bid
12 weeks
20 | years-old | <= |
Not applicable |
Male and Female
Inhaled corticosteroids-naive mild-to-moderate asthmatic patients
1 Current smoker
2 Past treatment with inhaled corticosteroids
3 Receiving oral corticosteroids in the previous 2 months
45
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
075-751-3830
1st name | |
Middle name | |
Last name | Masafumi Yamaguchi |
Kyoto University Graduate School of Medicine
Department of Respiratory Medicine
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
075-751-3830
Kyoto University Graduate School of Medicine
Kyoto University Graduate School of Medicine
Self funding
Japan
None
None
NO
2007 | Year | 03 | Month | 09 | Day |
Unpublished
Completed
2005 | Year | 04 | Month | 13 | Day |
2005 | Year | 05 | Month | 01 | Day |
2006 | Year | 07 | Month | 01 | Day |
2006 | Year | 07 | Month | 01 | Day |
2006 | Year | 07 | Month | 01 | Day |
2006 | Year | 07 | Month | 01 | Day |
2007 | Year | 03 | Month | 09 | Day |
2007 | Year | 03 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000766
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