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The purpose of this study is to examine in children with persistent AR the effect of the topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by acoustic rhinometry and subjective nasal symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beclometasone Dipropionate (BDP) | Experimental | Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of Nasal Beclomethasone Dipropionate for 21 days. |
|
| CERCHIO 10 mg/ml OS | Active Comparator | For Children < 12 years old 10 drops die (5 mg die) for 21 days. For Children > 12 years old 20 drops die (10 mg die) for 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Beclomethasone Dipropionate | Drug | Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of nebulized Beclomethasone Dipropionate nasal spray for 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nasal patency evaluated by acoustic rhinometry. | The main objective is to assess the increase of nasal patency in children aged 6-16 with perennial allergic rhinitis (PAR), treated with Beclometasone nasal spray 100 µg/die for 21 days. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Beclometasone nasal spray on subjective nasal symptoms | The secondary objective is to measure the impact of Beclometasone nasal spray 100 µg on subjective nasal symptoms, in children aged 6-16 with perennial allergic rhinitis (PAR), assessed by T4SS Questionnaire(Total 4 Symptoms Score). | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council | Palermo | Sicily | 90146 | Italy | ||
The IPD collected will be available on February 2017.
The following participant data will be shared:
All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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|
| CERCHIO 10 mg/ml OS | Drug | For Children < 12 years old 10 drops die (5 mg die) for 21 days. For Children > 12 years old 20 drops die (10 mg die) for 21 days. |
|
| Institute of Biomedicine and Molecular Immunology, IBIM |
| Palermo |
| 90146 |
| Italy |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |