drugset / Trial / NCT02409563
Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis
RandomizedParallel-groupSingle-blindTreatment
Summary
In clinical trials for treatment of allergic rhinitis a significant reduction of the total symptom score compared to baseline has been demonstrated by using nasal budesonide.Previous results in adults show that the assessment and monitoring del nasal fractional exhaled nitric oxide (nFeNO) is useful in controlling inflammation of nasal allergic rhinitis. Primary objective of this study is to evaluate efficacy of nasal budesonide (aqueous solution) on the nasal inflammation marker (nFeNO). Secondary outcomes are the evaluation of: changes in total nasal symptom score (Total Symptom Score, T5SS), changes in cell counts in nasal lavage (LN) and the changes reported sleep quality (Pittsburgh Sleep Quality Index, PSQI).
Timeline
- Start
- 2014-01
- Primary completion
- 2014-03
- Completion
- 2014-03
Publications
- Results Meltzer EO. Clinical and antiinflammatory effects of intranasal budesonide aqueous pump spray in the treatment of perennial allergic rhinitis. Ann Allergy Asthma Immunol. 1998 Aug;81(2):128-34. doi: 10.1016/S1081-1206(10)62798-6.
- Results Pedroletti C, Lundahl J, Alving K, Hedlin G. Effect of nasal steroid treatment on airway inflammation determined by exhaled nitric oxide in allergic schoolchildren with perennial rhinitis and asthma. Pediatr Allergy Immunol. 2008 May;19(3):219-26. doi: 10.1111/j.1399-3038.2007.00613.x.
- Results Meltzer EO, Munafo DA, Chung W, Gopalan G, Varghese ST. Intranasal mometasone furoate therapy for allergic rhinitis symptoms and rhinitis-disturbed sleep. Ann Allergy Asthma Immunol. 2010 Jul;105(1):65-74. doi: 10.1016/j.anai.2010.04.020.
- Results Bellodi S, Tosca MA, Pulvirenti G, Petecchia L, Serpero L, Silvestri M, Sabatini F, Battistini E, Rossi GA. Activity of budesonide on nasal neutrophilic inflammation and obstruction in children with recurrent upper airway infections. A preliminary investigation. Int J Pediatr Otorhinolaryngol. 2006 Mar;70(3):445-52. doi: 10.1016/j.ijporl.2005.07.015. Epub 2005 Sep 2.
- Results Baraldi E, Azzolin NM, Carra S, Dario C, Marchesini L, Zacchello F. Effect of topical steroids on nasal nitric oxide production in children with perennial allergic rhinitis: a pilot study. Respir Med. 1998 Mar;92(3):558-61. doi: 10.1016/s0954-6111(98)90308-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 50 ug | Intranasal |
| Subject | Budesonide | Small molecule | 100 ug | Intranasal |