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| ID | Type | Description | Link |
|---|---|---|---|
| A070001 | Other Grant/Funding Number | The Korean Health 21 R&D Project and MSD |
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| Name | Class |
|---|---|
| Hallym University Medical Center | OTHER |
| Wonju Severance Christian Hospital | OTHER |
| Korea University Guro Hospital | OTHER |
| MCM Vaccines B.V. |
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To compare the efficacy of combination therapy of montelukast plus low dose inhaled budesonide and single therapy of medium dose inhaled budesonide on asthma control such as inflammatory markers and clinical indicators and to compare treatment response according to leukotriene related genotypes in elderly patients with asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy of medium dose ICS | Active Comparator |
| |
| Combination of low ICS and montelukast | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of low ICS and montelukast | Drug | Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m and take orally a tablet of Singulair® 10mg one time per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients reaching "well controlled asthma status" | Rate of patients reaching "well controlled asthma status" after 12-week treatment : evaluating comprehensively frequency of day symptoms and night symptoms, limit of activities and use of rescue medicine based on GINA guideline for asthma management (GINA 2006) and PEF or FEV1(% predicted) | 12-weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of inflammation | sputum eosinophils and neutrophils | baseline(W1), W5, W9, W13, W17 |
| Time to first well-controlled week | during the 12 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hae-Sim Park, MD, PhD | Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Medical Center | Suwon | 443-721 | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 26, 2014 | |
| Reset | Apr 8, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 26, 2014 | Apr 8, 2014 |
| ID | Term |
|---|---|
| C093875 | montelukast |
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| INDUSTRY |
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| Monotherapy of medium dose ICS | Drug | Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m. and between 7 p.m. and 10 p.m. two times per day |
|
| Sub-group analysis of leukotrienes associated genotypes | visit 1 |