Unique ID issued by UMIN | UMIN000024905 |
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Receipt number | R000028656 |
Scientific Title | A randomized, open-label, crossover study to evaluate ICS/LABA treatment versus LAMA/LABA treatment in COPD with eosinophilic inflammation |
Date of disclosure of the study information | 2016/11/21 |
Last modified on | 2018/09/07 17:23:21 |
A randomized, open-label, crossover study to evaluate ICS/LABA treatment versus LAMA/LABA treatment in COPD with eosinophilic inflammation
COPD and eosinophilic inflammation.
A randomized, open-label, crossover study to evaluate ICS/LABA treatment versus LAMA/LABA treatment in COPD with eosinophilic inflammation
COPD and eosinophilic inflammation.
Japan |
COPD
Medicine in general | Pneumology |
Others
NO
To evaluate ICS/LABA treatment versus LAMA/LABA treatment in COPD with eosinophilic inflammation.
Efficacy
Exploratory
FEV1 after 4 weeks of treatment.
Dyspnoea, symptoms, FENO level, and blood eosinophils after 4 weeks of treatment. Adverse events and exacerbation.
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
YES
2
Treatment
Medicine |
Treatment with ICS/LABA for 4 weeks, then treatment with LAMA/LABA for 4 weeks.
Treatment with LAMA/LABA for 4 weeks, then tteatment with ICS/LABA for 4 weeks.
40 | years-old | <= |
Not applicable |
Male and Female
Severity of airflow limitation as GOLD 2-4; have a smoking history of at least 10 pack-years; and FENO level of at least 25 ppb.
Asthma overlap (ACOS); history of lung resection; using inhaled or oral corticosteroid; receiving anti-IgE therapy; and exacerbation of COPD in the 4 weeks.
25
1st name | |
Middle name | |
Last name | Seiichi Kobayashi |
Japanese Red Cross Ishinomaki Hospital
Department of Respiratory Medicine
71 Nishimichishita, Hebita, Ishinomaki, Japan
0225-21-7220
skoba-thk@umin.ac.jp
1st name | |
Middle name | |
Last name | Seiichi Kobayashi |
Japanese Red Cross Ishinomaki Hospital
Department of Respiratory Medicine
71 Nishimichishita, Hebita, Ishinomaki, Japan
0225-21-7220
skoba-thk@umin.ac.jp
Department of Respiratory Medicine, Japanese Red Cross Ishinomaki Hospital
NON
Self funding
NO
石巻赤十字病院
2016 | Year | 11 | Month | 21 | Day |
Unpublished
Terminated
2016 | Year | 11 | Month | 02 | Day |
2016 | Year | 11 | Month | 21 | Day |
2018 | Year | 09 | Month | 07 | Day |
2016 | Year | 11 | Month | 19 | Day |
2018 | Year | 09 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028656
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