Unique ID issued by UMIN | UMIN000023109 |
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Receipt number | R000026634 |
Scientific Title | The effects of budesonide therapy on airway hypersecretion and/or sputum excretion failure in asthma patients; open label study |
Date of disclosure of the study information | 2016/08/01 |
Last modified on | 2016/07/11 14:44:57 |
The effects of budesonide therapy on airway hypersecretion and/or sputum excretion failure in asthma patients; open label study
The effects of budesonide therapy on sputum excretion failure in asthma patient
The effects of budesonide therapy on airway hypersecretion and/or sputum excretion failure in asthma patients; open label study
The effects of budesonide therapy on sputum excretion failure in asthma patient
Japan |
Asthma
Pneumology |
Others
NO
To compare the effects of budesonide therapy a on airway hypersecretion and/or sputum excretion failure in Japanese patients
Efficacy
Exploratory
Pragmatic
Changes in m-CASA-Q efficacy(%) from before to after 8 weeks treatment
Changes in lung function (%FEV1/%PEF) from before to after 8 weeks treatment
Changes in eosinophil and neutrophil from before to after 8 weeks treatment
Changes in ECP and mucin from before to after 8 weeks treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Budesonide group
Budesonide 200micro;g two inhalations bid (morning and evening)
20 | years-old | <= |
Not applicable |
Male and Female
- Signed informed consent by the patient
- Outpatient, man or woman, 20 years or older
- Diagnosis of asthma
- Sputum over the past 8 weeks
patien
- Patients with a history of hypersensitivity (including contact dermatitis) to any ingredient contained in the study drugs
- Patients with infections with no available effective antimicrobial drugs or with deep seated mycosis
- Patients with tuberculosis
- Respiratory infection, judged by the investigator as an infection affecting the asthma, within 8 weeks prior to enrollment
- Use of any beta-blocking agents
- Treatment with oral, parenteral or rectal steroids within 30 days prior to enrollment
- Any significant disease or disorder judged by the investigator
- Current or previous with a smoking
30
1st name | |
Middle name | |
Last name | Jun Tamaoki |
Tokyo Women's Medical University
Respiratory Medicine
8-1 Kawada-Cho, Shinjuku, Tokyo
03-3353-8111
jtamaoki@chi.twmu.ac.jp
1st name | |
Middle name | |
Last name | Jun Tamaoki |
Tokyo Women's Medical University
Respiratory Medicine
8-1 Kawada-Cho, Shinjuku, Tokyo
03-3353-8111
jtamaoki@chi.twmu.ac.jp
Tokyo Women's Medical University
Tokyo Women's Medical University
Self funding
NO
2016 | Year | 08 | Month | 01 | Day |
Unpublished
Preinitiation
2016 | Year | 04 | Month | 01 | Day |
2016 | Year | 08 | Month | 01 | Day |
2016 | Year | 07 | Month | 11 | Day |
2016 | Year | 07 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026634
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