Sinuclean Nebules treatment in children suffering from otitis media with effusion.

OBJECTIVE: Otitis media with effusion (OME) is an ear disorder defined by the presence of fluid in the middle ear without signs or symptoms of acute infection. The current randomized, double-blind, controlled study aimed to evaluate whether Sinuclean Nebules treatment, administered by nasal douche (Rinowash), could induce ear healing better than isotonic saline in children with OME. METHODS: The study was randomized, double-blind, and controlled. Group A (30 children) was treated with Sinuclean Nebules 45 and Group B (31 children) was treated with isotonic saline; both compounds were administered by nasal nebulization with Rinowash nasal douche twice/day in the morning and in the evening for 10 days, followed by a one-week suspension, and after by a second course as the first. Tympanogram and audiometry were performed at baseline and after treatment. RESULTS: Considering the global evaluation of the treatment: in Group A, 28 (93.3%) patients had complete resolution and 2 (6.7%) had partial resolution; in Group B, all patients had failure of treatment. There was a significant difference between groups (p < 0.0001). CONCLUSION: The current randomized-controlled study demonstrated that Sinuclean Nebules was effective and in the treatment of children with OME.

Inhaled hyaluronic acid as ancillary treatment in children with bacterial acute rhinopharyngitis.

Acute rhinopharyngitis (ARP) is the most common upper respiratory infection in children and represents a social problem for both the pharmaco-economic impact and a burden for the family. Topical antibiotic therapy is usually effective in bacterial ARP, but ancillary treatment might improve its efficacy. Hyaluronic acid (HA) is a promising molecule that has been recently proposed in upper respiratory disorders. Therefore, the purpose of this study was to evaluate the effects of ancillary HA treatment in children with bacterial ARP. Globally, 51 children (27 males, mean age 5.9 ± 2.1 years) with bacterial ARP were enrolled in the study. At baseline, children were randomly assigned to the treatment with: 125 mg of thiamphenicol diluted in 4 mL of saline isotonic solution twice daily (group A) or with 125 mg of thiamphenicol plus 4 ml of sodium hyaluronate 0.2% plus xylitol 5% (Aluneb, Sakura Italia) twice daily (group B) administered by the nasal device Rinowash (Airliquide Medical System, Italy) and connected to an aerosol nebulizer with pneumatic compressor (1.5 bar per 5 L/min) Nebula (Airliquide Medical System, Italy), for 10 days. sVAS, nasopharyngeal spotting, neutrophils and bacteria were assessed at baseline and after the treatment. Both treatments induced significant reduction of symptom perception, spotting, neutrophil and bacteria count. However, thiamphenicol plus HA was able to significantly induce a greater effect on sVAS (p=0.006), neutrophil count (p=0.01), and bacteria count (p=0.0003) than thiamphenicol alone. In conclusion, this study provides the first evidence that intranasal HA, as ancillary treatment, may be able to improve topical antibiotic efficacy in children with bacterial ARP.

Intranasal flunisolide treatment in patients with non-allergic rhinitis.

Non-allergic rhinitis (NAR) is a heterogeneous disease, characterized by nasal hyperreactivity and inflammation. Its treatment is still debated, intranasal corticosteroids may be an option. The present study is aimed at evaluating the effect of the use of intranasal flunisolide in patients with NAR, considering both clinical and cytological parameters. Sixty patients were treated with intranasal flunisolide (30) or saline solution (30) for 8 weeks. Symptom severity, turbinate size, and inflammatory cell counts were assessed, before and after treatment. Intranasal flunisolide induced a significant reduction of symptoms, turbinate size, and cellular infiltrate. Thus, intranasal flunisolide might be a therapeutic option for NAR.

The nose and paranasal sinuses.

The airways should be considered as a functional unit. Indeed, disorders involving the upper respiratory tract (URT) spread to the lower respiratory tract (LRT). Modern functional anatomy divides URT in three, mutually dependent, junction boxes: i) the ostio-meatal complex (OMC), ii) the spheno-ethmoidal recess (SER), and iii) the rhinopharynx (RP). The first is the most interesting as it joins the anterior paranasal sinuses with the nose. The correct ventilation and the effective mucociliary clearance of these three pathophysiologic junction boxes condition the healthy physiology of the entire respiratory system. The OMC, SER and RP obstruction is the first pathogenic step in the inflammatory cascade of the rhino-sinusal-pharyngeal disorders. The inflammation of the respiratory mucosa is the main pathogenic factor for airway obstruction that may be generically defined as a heterogeneous group of pathologies. Moreover, the bacterial biofilms are an important local cause of recurrent diseases: they are a strategic modality of survival set up by bacteria and the main cause of their resistance to systemic antibiotic therapy.

Prevention of surgery in children with adenoidal hypertrophy treated with intranasal flunisolide: a 12-month follow-up.

Adenoidal hypertrophy (AH) represents one of the most frequent indications for surgery in children. Recently, treatment with intranasal corticosteroids has been suggested to decrease the size of AH. The aim of the study is to evaluate the long-term effect of intranasal flunisolide on AH during a 12-month follow-up. One hundred seventy-eight children with a grade III or IV AH at baseline endoscopic examination were enrolled in this randomised and controlled study. Children were treated with intranasal flunisolide or isotonic saline solution for 8 weeks. Subsequent assessment, including history and fiberoptic endoscopy, was made at 8 weeks, and 6 and 12 months after treatment suspension. Flunisolide treatment was initially associated with significant (p<0.01) reduction of the degree of AH. However, during follow-up all but one of the non-allergic children relapsed, whereas most allergic children maintained AH size reduction (p<0.05). No clinically important adverse events were reported. In conclusion, this preliminary study demonstrates that an 8-week treatment with intranasal flunisolide is significantly associated with reduction of AH, however, the adenoidectomy avoidance was warranted only for allergic children.

Intranasal flunisolide treatment in children with adenoidal hypertrophy.

Adenoidal hypertrophy (AH) represents one of the most frequent indications for surgery in children and it has been proposed that treatment with intranasal corticosteroids can decrease the size of AH. Therefore, the aim of the study is to evaluate the effect of the use of intranasal flunisolide among children affected by AH. 178 children with AH were evaluated in this randomised and controlled study. Inclusion criteria for the study required that each patient had to have a III or IV degree of AH on the initial endoscopic examination. Children were treated with intranasal flunisolide or isotonic saline solution for 8 weeks. After treatment, endoscopy was performed to re-evaluate AH degree. Flunisolide treatment was associated with significant (p less than 0.04) reduction of AH degree. There was moreover a consistent reduction of children (46 out of 58) proposed to adenoidectomy. No clinically important adverse events were reported. In conclusion, this preliminary study demonstrates that an 8-week treatment with intranasal flunisolide is significantly associated with reduction of AH, thus preventing the recurrence to adenoidectomy, and is safe.

Sublingual allergen-specific immunotherapy in allergic rhinitis and related pathologies: Efficacy in a paediatric population.

The aim of this study was to demonstrate the efficacy and safety of the sublingual-swallow allergen-specific immunotherapy (SLIT) in a paediatric population suffering from allergic rhinitis and related pathologies. From March 1994 through March 2000, at our ENT Department 4000 children (1800 male and 2200 female), aged 3 to14 years, were examined for recurrent nasal obstruction and nasal polyps. 2400 (60%) of them were allergic and underwent the following investigations: Impedance test, Pure tone audiometry, rhinomanometry, Prick test, RAST, nasal provocation test and paranasal sinus TC without contrast media. Of the allergic group we admitted 288 patients(12%) to a 3 yr SLIT, meeting the following criteria: children aged 5 years or more, mono-sensitised to one allergen and with family cooperation support. After three years of SLIT, we observed complete symptom remission and a marked improvement in instrumental examinations in 80% of these children. The improvement was poor in 8% of patients, while in 12% of the subjects no changes in symptoms and instrumental results were detected. These results are in agreement with previously published studies and confirm that SLIT can be a valid tool for treating allergic upper respiratory tract diseases in children.