Unique ID issued by UMIN | UMIN000015602 |
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Receipt number | R000018129 |
Scientific Title | Evaluation of the clinical efficacy and safety of fluticasone propionate/ formoterol fumarate combination (FFC) for the treatment of bronchial asthma-with and without use of an inhalation device |
Date of disclosure of the study information | 2014/11/04 |
Last modified on | 2015/11/21 18:49:25 |
Evaluation of the clinical efficacy and safety of fluticasone propionate/ formoterol fumarate combination (FFC) for the treatment of bronchial asthma-with and without use of an inhalation device
Evaluation of the clinical efficacy and safety of fluticasone propionate/ formoterol fumarate combination (FFC) for the treatment of bronchial asthma-with and without use of an inhalation device
Evaluation of the clinical efficacy and safety of fluticasone propionate/ formoterol fumarate combination (FFC) for the treatment of bronchial asthma-with and without use of an inhalation device
Evaluation of the clinical efficacy and safety of fluticasone propionate/ formoterol fumarate combination (FFC) for the treatment of bronchial asthma-with and without use of an inhalation device
Japan |
Bronchial Asthma
Medicine in general |
Others
NO
To evaluate efficacy and safety of FFC with and without use AeroChamber Plus on lung function
Safety,Efficacy
FEV1
Lung function Score
Asthma Control Questionnaire
FeNO
Impulse Oscillation System
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is considered as a block.
YES
Numbered container method
2
Treatment
Medicine | Device,equipment |
Inhalation of FFC without AeroChamber Plus--> With AeroChamber Plus
Inhalation of FFC with AeroChamber Plus--> Without AeroChamber Plus
20 | years-old | <= |
Not applicable |
Male and Female
1) Outpatient >=20 years old
2) Patients who were diagnosed with asthma and need ICS and LABA by the investigator.
3) Patients with %FEV1 more than 60% at visit1
4) Documented agreement with full explanation of the study to the participant.
1) Patients with any serious cardiac, hepatic, renal, hematological disorder, or any other serious complication
2) Patients who have coexisting malignant tumor or a history of malignant tumor
3) Patients who have history of smoking within the past 1 year
4) Patients who are pregnant, lactating, possibly pregnant, or those who desire to become pregnant during their participation in the study
5) Others deemed unsuitable by the investigator
50
1st name | |
Middle name | |
Last name | Yuji Tohda |
Kinki University
Department of respiratory medicine and allergology
377, Ohnohigashi Osakasayama-city,Osaka, Japan
072-366-0221
tohda@med.kindai.ac.jp
1st name | |
Middle name | |
Last name | Yuji Tohda |
Kinki University
Department of respiratory medicine and allergology
377, Ohnohigashi Osakasayama-city,Osaka, Japan
072-366-0221
tohda@med.kindai.ac.jp
Kinki university Department of respiratory medicine and allergology
None
Self funding
NO
2014 | Year | 11 | Month | 04 | Day |
Unpublished
Enrolling by invitation
2014 | Year | 07 | Month | 04 | Day |
2014 | Year | 08 | Month | 01 | Day |
2014 | Year | 11 | Month | 04 | Day |
2015 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018129
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