Unique ID issued by UMIN | UMIN000001009 |
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Receipt number | R000001216 |
Scientific Title | Open-label, single-center, randomized and parallel-group study to compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough |
Date of disclosure of the study information | 2008/02/01 |
Last modified on | 2010/03/30 17:12:41 |
Open-label, single-center, randomized and parallel-group study to compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough
Study to compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough
Open-label, single-center, randomized and parallel-group study to compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough
Study to compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough
Japan |
Prolonged and chronic cough
Pneumology |
Others
NO
To compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough by using symptom scores, VAS score, cough sensitivity test and biomarkers and neuropeptide of induced sputum and plasma.
Efficacy
Confirmatory
Pragmatic
Phase IV
Symptom scores and VAS score(at 0 and 2 weeks)
Capsaicin cough sensitivity test(at 0 and 2weeks)
Concentrations of substance P in sputum and plasma(at 0 and 2weeks)
1. Pulmonary function tests(at 0 and 2weeks)
2. Inflammatory biomarkers of induced sputum and serum(at 0 and 2weeks)
3. Exhaled nitric oxide concentration(at 0 and 2weeks)
4. Parameters of impulse oscillometry(at 0 and 2weeks)
5. safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
Numbered container method
2
Treatment
Medicine |
olopatadine hydrochloride
5mg b.i.d, for 2 weeks
dextromethorphan hydrobromide
15mg t.i.d, for 2 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1. Cough persisting for longer than 3 weeks.
2. No radiological evidence of chest disease.
3. Who gave written informed consent.
1. Patients with a history of hypersensitivity to olopatadine hydrochloride or dextromethorphan hydrobromide
2. Patients receiving monoamine oxidase inhibitor (MAOI) therapy and for 14 days after stopping MAOI therapy
3. Patients with a history of other chest disease
4. Patients taking angiotensin-converting enzyme inhibitors.
5. Patients during pregnancy or lactation
6. Inappropriate patients from the doctor's viewpoint
60
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.
1st name | |
Middle name | |
Last name | Kojiro Otsuka |
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
None
Self funding
NO
2008 | Year | 02 | Month | 01 | Day |
Unpublished
Completed
2007 | Year | 12 | Month | 19 | Day |
2008 | Year | 02 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2008 | Year | 02 | Month | 01 | Day |
2010 | Year | 03 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001216
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