Unique ID issued by UMIN | UMIN000001177 |
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Receipt number | R000001441 |
Scientific Title | Open-label, single-center, randomized and parallel-group study to exmamine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma. |
Date of disclosure of the study information | 2008/06/06 |
Last modified on | 2012/06/07 20:03:44 |
Open-label, single-center, randomized and parallel-group study to exmamine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.
Study to examine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.
Open-label, single-center, randomized and parallel-group study to exmamine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.
Study to examine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.
Japan |
Bronchial asthma
Pneumology |
Others
NO
To compare the effect of tulobuterol transdermal therapeutic system(TTS) and that of salmeterol dry powder inhaler on large and small airways involvement in bronchial asthma by using impulse oscillometry and exhaled nitric oxide measurements.
Efficacy
Confirmatory
Pragmatic
Phase IV
Parameters of impulse oscillometry
1. Indices of pulmonary function
2. Exhaled nitric oxide concentrations
3. degree of dyspnea (using Medical Research Council dyspnea scale)
4. Quality of life (using St. George's Respiratory Questionnaire)
5. ACT(asthma control test)
6. clinical symptoms(such as wheezing)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Add tulobuterol transdermal therapeutic system(TTS) 2 mg once daily to the current medication
Add inhaled salmeterol 50 mcg twice daily to the current medication
20 | years-old | <= |
Not applicable |
Male and Female
1. Mild or moderate asthma
2. Poorly controlled patients who need additional controler medication to the current treatment including inhaled corticosteroid
3. Astmatic patients diagnosed definitely by airway responsiveness test or airway reversibility test
4. Never smokers or ex-smokers of < 10 pack-years who quit smoking for > one year
1. Patients with concomitant respiratory disease that may interfere with evaluation of outcomes
2. Patients with hypersensitivity to salmeterol or tulobuterol
3. Patients with dermal disease potentially intolerant to transdermal medication
4. Patients with hyperthyroidism or cardiovascular disease which preclude a use of beta-agonist
5. Pregnancy or lactation
6. Patients who are considered inappropriate by physicians in charge
50
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, Japan.
075-751-3830
1st name | |
Middle name | |
Last name | Hideki Inoue |
Kyoto University Graduate School of Medicine
Department of Respiratory Medicine
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan.
075-751-3830
Kyoto University Graduate School of Medicine
Kyoto University Graduate School of Medicine
Self funding
NO
2008 | Year | 06 | Month | 06 | Day |
Unpublished
Completed
2008 | Year | 04 | Month | 16 | Day |
2008 | Year | 06 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2008 | Year | 06 | Month | 05 | Day |
2012 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001441
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