Unique ID issued by UMIN | UMIN000000627 |
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Receipt number | R000000759 |
Scientific Title | Open-label, single-center, randomized and parallel-group study to compare the effect of inhaled corticosteroids and leukotriene receptor antagonists in patients with cough variant asthma. |
Date of disclosure of the study information | 2007/03/01 |
Last modified on | 2008/09/04 17:04:42 |
Open-label, single-center, randomized and parallel-group study to compare the effect of inhaled corticosteroids and leukotriene receptor antagonists in patients with cough variant asthma.
Controlled study to compare the effect of inhaled corticosteroids and leukotriene receptor antagonists in cough variant asthma
Open-label, single-center, randomized and parallel-group study to compare the effect of inhaled corticosteroids and leukotriene receptor antagonists in patients with cough variant asthma.
Controlled study to compare the effect of inhaled corticosteroids and leukotriene receptor antagonists in cough variant asthma
Japan |
Cough variant asthma
Pneumology |
Others
NO
To compare the efficacy of short course treatment with high dose budesonide (BUD), low dose BUD and montelukast in patients with newly diagnosed cough variant asthma, in terms of symptoms, bronchial responsiveness, cough sensitivity, airway inflammation assessed by sputum and prognosis.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Coughing symptom
1 Symptom
2 Capsaicin cough sensitivity
3 Methacholine airway responsiveness
4 Pulmonary function test
5 Inflammatory biomarker of induced sputum and peripheral blood
6 Safety
7 Progression to classical asthma
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
Numbered container method
3
Treatment
Medicine |
High dose budesonide
600mcg bid
3 months
Low dose budesonide
200mcg bid
3 months
Montelukast
10mg once a day
3 months
20 | years-old | <= |
Not applicable |
Male and Female
1 Chronic cough persisting for longer than 8 weeks without wheezing or dyspnea
2 No other concomitant respiratory disease within 8 weeks
3 Presence of airway hyperrespon- siveness
4 Symptomatic response of coughing to bronchodilators
5 Normal chest radiograph
1 Current smoker
2 Past treatment with inhaled corticosteroids or leukotriene receptor antagonists
3 Receiving oral corticosteroids in the previous 2 months
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
075-751-3830
1st name | |
Middle name | |
Last name | Masafumi Yamaguchi |
Kyoto University Graduate School of Medicine
Department of Respiratory Medicine
54 Kawahara-cho, Shogoin, Sakyo- ku, Kyoto
075-751-3830
Kyoto University Graduate School of Medicine
Kyoto University Graduate School of Medicine
Self funding
NO
2007 | Year | 03 | Month | 01 | Day |
Unpublished
No longer recruiting
2006 | Year | 03 | Month | 17 | Day |
2007 | Year | 04 | Month | 01 | Day |
2009 | Year | 09 | Month | 01 | Day |
2009 | Year | 09 | Month | 01 | Day |
2009 | Year | 09 | Month | 01 | Day |
2009 | Year | 09 | Month | 01 | Day |
2007 | Year | 03 | Month | 01 | Day |
2008 | Year | 09 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000759
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