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The aim of the project is to evaluate whether therapy with leukotriene may be a valid therapeutic approach in children with adenotonsillar hypertrophy and with mild and moderate obstructive sleep apnea syndrome (OSAS) and to evaluate whether leukotriene is less, equally or more efficient than nasal steroid.
The aim of the project is to evaluate whether leukotriene is less, equally or more efficient than nasal steroid in children with adenotonsillar hypertrophy and with mild and moderate OSAS checking if leukotriene administrated for 24 weeks improves overnight oximetry, polysomnography and checking if leukotriene as anti-inflammatory of upper airway really reduces the tonsils and adenoids dimensions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal steroid | Active Comparator |
| |
| Anti-leukotrienes | Active Comparator |
| |
| Nasal steroid + anti-leukotrienes | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide (Aircort 50 nasal spray) | Drug | 50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal polysomnography in the first visit compared with Nocturnal polysomnography in the last visit in patient with Montelukast treatment: | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the clinical upper airway patency during the night in the patients with history of allergic rhinitis compared with the patients without history of allergic rhinitis first and after the treatment for OSAS | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Filippo Bernardi, Professor | University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department if Pediatrics, Hospital S. Orsola-Malpighi , University of Bologna | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17400731 | Background | Gozal D, Crabtree VM, Sans Capdevila O, Witcher LA, Kheirandish-Gozal L. C-reactive protein, obstructive sleep apnea, and cognitive dysfunction in school-aged children. Am J Respir Crit Care Med. 2007 Jul 15;176(2):188-93. doi: 10.1164/rccm.200610-1519OC. Epub 2007 Mar 30. | |
| 16840394 | Background | Goldbart AD, Krishna J, Li RC, Serpero LD, Gozal D. Inflammatory mediators in exhaled breath condensate of children with obstructive sleep apnea syndrome. Chest. 2006 Jul;130(1):143-8. doi: 10.1378/chest.130.1.143. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| montelukast (Singulair) | Drug | Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older |
|
|
| 16798597 | Background | Gozal D, Kheirandish-Gozal L. Sleep apnea in children--treatment considerations. Paediatr Respir Rev. 2006;7 Suppl 1:S58-61. doi: 10.1016/j.prrv.2006.04.174. Epub 2006 Jun 5. |
| 16396849 | Background | Kheirandish L, Goldbart AD, Gozal D. Intranasal steroids and oral leukotriene modifier therapy in residual sleep-disordered breathing after tonsillectomy and adenoidectomy in children. Pediatrics. 2006 Jan;117(1):e61-6. doi: 10.1542/peds.2005-0795. |
| 15879419 | Background | Goldbart AD, Goldman JL, Veling MC, Gozal D. Leukotriene modifier therapy for mild sleep-disordered breathing in children. Am J Respir Crit Care Med. 2005 Aug 1;172(3):364-70. doi: 10.1164/rccm.200408-1064OC. Epub 2005 May 5. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |