Unique ID issued by UMIN | UMIN000006290 |
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Receipt number | R000007448 |
Scientific Title | An open-label, randomized, parallel group study to compare the changes in asthma control variables by budesonide vs. budesonide/formoterol in mild to moderate asthmatic patients |
Date of disclosure of the study information | 2011/09/15 |
Last modified on | 2013/03/06 09:14:06 |
An open-label, randomized, parallel group study to compare the changes in asthma control variables by budesonide vs. budesonide/formoterol in mild to moderate asthmatic patients
A comparison of the changes in asthma control variables by budesonide versus budesonide/formoterol
An open-label, randomized, parallel group study to compare the changes in asthma control variables by budesonide vs. budesonide/formoterol in mild to moderate asthmatic patients
A comparison of the changes in asthma control variables by budesonide versus budesonide/formoterol
Japan |
Bronchial asthma
Pneumology | Clinical immunology |
Others
NO
To compare the degree of improvement on clinical variables for asthma (symptoms, airflow obstruction, airway hyperresponsivness, airway inflammation) by budesonide and budesonide/formoterol for the treatment of mild to moderate asthma
Efficacy
Change from baseline (Week 0) in the airway hyperresponsiveness at Week 2, 4, 8 and 24
Change from baseline (Week 0) in the following clinical variables at Week 2, 4, 8 and 24
1) ACQ
2) Respiratory function
3) Exhaled nitric oxide
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Budesonide group
Pulmicort (200mcg) Turbuhaler one inhalation, twice daily for 24 weeks
Budesonide/formoterol group
Symbicort (160/4.5mcg) Turbuhaler one inhalation, twice daily for 24 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1)Adult outpatient with mild persistent and moderate asthma
2)Patient with inhaled steroid naive
3)Nonsmoking patient
4)Patients who has provided written consent prior to enrollment
1)Patients with a history of hypersensitivity (including contact dermatitis) to any ingredient contained in the budesonide/formoterol combination
2)Patients with infectious with no available effective antimicrobial drugs or with deep-seated mycosis
3)Patients with other respiratory illnesses (including lung cancer, tuberculosis, bronchiectasis)
4)Patients with heart failure
5)Patients who contracted a respiratory infection that could influence asthma within the last 4 weeks
6)Patients who ere treated with systemic corticosteroids in the last 4 weeks
7)Patients with RE
8)Patients with other severe diseases
9)Patients who are considered inappropriate by the physician in charge
30
1st name | |
Middle name | |
Last name | Masakazu Ichinose |
Wakayama Medical University, School of Medicine
Third Department of Internal Medicine
811-1 Kimiidera, Wakayama, Japan
1st name | |
Middle name | |
Last name | Kazuto Matsunaga |
Wakayama Medical University, School of Medicine
Third Department of Internal Medicine
kazmatsu@wakayama-med.ac.jp
Third Department of Internal Medicine, Wakayama Medical University, School of Medicine
None
Self funding
NO
2011 | Year | 09 | Month | 15 | Day |
Published
BUD/FM showed a significant rapid improvement in asthma control than BUD alone.
Completed
2011 | Year | 08 | Month | 15 | Day |
2011 | Year | 09 | Month | 01 | Day |
The results of this study has been reported in pulmonary pharmacology & therapeutics 2013, p189-p194.
2011 | Year | 09 | Month | 06 | Day |
2013 | Year | 03 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007448
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