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The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.
During the pollen season children with seasonal allergic rhinitis without concomitant asthma are at risk of having allergic inflammation in the lower respiratory tract. About 60% of children with seasonal allergic rhinitis present bronchial hyperresponsiveness and signs and symptoms of asthma.
The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | monteluksat sodium |
|
| 2 | Active Comparator | cetirizine |
|
| 3 | Active Comparator | montelukast sodium and cetirizine |
|
| 4 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast | Drug | montelukast sodium |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| exhaled nitric oxide concentration | baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit) |
| Measure | Description | Time Frame |
|---|---|---|
| symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements | baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Violetta Ĺcibiorek, MD | Contact | 00 48 42 6895972 | alergol@kopernik.lodz.pl |
| Name | Affiliation | Role |
|---|---|---|
| Violetta Ĺcibiorek, MD | Department of Pediatrics and Allergy, Medical University of Lodz, Poland | Principal Investigator |
| Iwona Stelmach, MD PhD Prof | Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland | Recruiting | Lodz | 93-513 | Poland |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| cetirizine | Drug | cetirizine |
|
| montelukast and cetirizine | Drug | montelukast and cetirizine |
|
| placebo | Drug | placebo |
|
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |