Multidisciplinary Decision-Making-ITAlian Consensus After Two Years of Real Practice on the Management of Severe Uncontrolled CRSwNP by Biologics (ITACA Study).

PURPOSE OF REVIEW: We aimed to reach an Italian multidisciplinary consensus on some crucial aspects of treatment decision making in CRSwNP, following 2 years of clinical experience in order to support specialists in the management of CRSwNP in clinical practice. We addressed issues relating to therapeutic decision-making and shared criteria for the treatment choice, as well as appropriate timing and criteria for evaluating treatment response, and highlighted the need for repeated multidisciplinary assessments. RECENT FINDINGS: A national survey has been conducted recently to understand how rhinology practice has changed in Italy with the advent of biologics and how this affects patients with uncontrolled, severe CRSwNP. Despite the many published consensus documents, practical recommendations, and protocols on the use of biologics in CRSwNP, heterogenous behaviors in practice are still observed mainly conditioned by the novelty of the topic. The consensus procedure followed a modified Delphi approach. The scientific board included 18 otorhinolaryngologists and 8 allergists, who selected the 4 main topics to be addressed and developed overall 20 statements. Consensus on these statements was sought by a larger group of 48 additional experts, through two rounds of voting, the first web-based, the second in presence with discussion and possible refinement of the statements. The statements reaching an average score ≥ 7 at the second voting round were approved. Five statements were proposed for each of the following topics: baseline evaluation of patients eligible for biologic therapy; choice between different therapeutic options; assessment of the response to biologic treatment; multidisciplinary management. At the first voting round, 19 out of the 20 statements reached a mean score ≥ 7. Following the discussion and a few consequent amendments, at the second round of voting all the 20 statements were approved.

Chronic rhinosinusitis with nasal polyposis: the role of personalized and integrated medicine.

Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a common disorder. From a clinical and immunopathological point of view, different phenotypes and endotypes have been identified. As asthma is frequent comorbidity, biological agents for treating CRSwNP associated with asthma may be an attractive strategy. Biological agents have several mechanisms, such as antagonizing IgE, interleukin (IL) 4, IL-5, and IL-13. However, a workup is mandatory, mainly concerning pheno-endotyping. In this regard, clinical cytological grading (CCG) has been proposed as a useful tool to manage patients with CRSwNP as it allows us to define clinical and immunopathological phenotypes able to identify the ideal candidate for biologics. In particular, the mixed cellular pattern, such as eosinophils and mast cells, could be sensitive to anti-IL-4 agents. There is still a need for well-established indications, criteria of responsiveness, duration, and safety. Moreover, personalized medicine could be opportunely integrated and/or alternated with intranasal corticosteroids to prevent relevant adverse events.

Broncalt®, class II medical device, in patients with acute upper airways disease: a survey in clinical practice.

Inflammation is a common pathogenic mechanism involved in many otorhinolaryngological (ORL) disorders. Broncalt® is a class II Medical Device containing: thermal water (Medesano, PR, Italy), hyaluronic acid, and grapefruit seed extract. It has been reported that it exerted a safe and effective anti-inflammatory, washing, and antimicrobial activity by virtue of these components. Therefore, the aim of the current survey, conducted in clinical practice of 84 Italian ORL centers, was to evaluate its safety and efficacy in the treatment of patients with acute upper airways disease. The 3,533 (1,797 males, mean age 43.5 years) patients were evaluated at baseline (T0) and after a 2-week treatment (T1) with or without Broncalt®. Signs and symptoms severity were measured by visual analogue scale. Broncalt® significantly and safely diminished the clinical features in all sub-groups (p<0.001 for all). Interestingly, Broncalt® significantly induced a faster symptom relief already within 3 days after the start of the treatment. In conclusion, Broncalt® is a class II Medical Device able to exert a safe and effective activity in patients with acute ORL disorders.

Broncalt®, class II medical device, in patients with chronic upper airways disease: a survey in clinical practice.

Inflammation and infection are common pathogenic mechanisms involved in many otorhinolaryngological (ORL) chronic diseases. Broncalt® is a class II Medical Device containing: thermal water (Medesano, PR, Italy), hyaluronic acid, and grapefruit seed extract. It could exert a safe and effective anti-inflammatory, washing, and antimicrobial activity by virtue of these components. Therefore, the aim of the current survey, conducted in clinical practice of 84 Italian ORL centers, was to evaluate its safety and efficacy in the treatment of patients with chronic upper airways disease. The 1,817 (958 males, mean age 49 years) patients were evaluated at baseline (T0) and after one (T1) and two (T2) weeks of treatment, they were treated or not treated with Broncalt®. Signs and symptoms severity were measured by visual analogue scale. Broncalt® significantly, quickly, and safely diminished the clinical features in all sub-groups (p<0.001 for all). In conclusion, Broncalt® is a class II Medical Device able to exert a safe, quick, and effective activity in patients with chronic ORL disorders.

Broncalt®, class II medical device, in patients with chronic relapsed upper airways disease: a survey in clinical practice.

Inflammation and infection are common pathogenic mechanisms involved in many otorhinolaryngological (ORL) chronic diseases. Broncalt® is a class II Medical Device containing: thermal water (Medesano, PR, Italy), hyaluronic acid, and grapefruit seed extract. It could exert a safe and effective anti-inflammatory, washing, and antimicrobial activity by virtue of these components. Therefore, the aim of the current survey, conducted in clinical practice of 84 Italian ORL centers, was to evaluate its safety and efficacy in the treatment of patients with chronic upper airways disease. The 1,817 (958 males, mean age 49 years) patients were evaluated at baseline (T0) and after one (T1) and two (T2) weeks of treatment, they were treated or not treated with Broncalt®. Signs and symptoms severity were measured by visual analogue scale. Broncalt® significantly, quickly, and safely diminished the clinical features in all sub-groups (p<0.001 for all). In conclusion, Broncalt® is a class II Medical Device able to exert a safe, quick, and effective activity in patients with chronic ORL disorders.

Double-blind placebo-controlled randomized clinical trial on the efficacy of Aerosal in the treatment of sub-obstructive adenotonsillar hypertrophy and related diseases.

BACKGROUND: Adenotonsillar hypertrophy (ATH) is a frequent cause of upper airways obstructive syndromes associated to middle ear and paranasal sinuses disorders, swallowing and voice disorders, sleep quality disorders, and occasionally facial dysmorphisms. ATH treatment is essentially based on a number of medical-surgical aids including nasal irrigation with topical antibiotics and corticosteroids and/or treatment with systemic corticosteroids, immunoregulators, thermal treatments, adenotonsillectomy, etc. OBJECTIVES: The aim of the present study is to assess the efficacy of Aerosal halotherapy in the treatment of sub-obstructive adenotonsillar disease and correlated conditions compared to placebo treatment. METHODS: A total of 45 patients with sub-obstructive adenotonsillar hypertrophy were randomized to receive either Aerosal halotherapy or placebo for 10 treatment sessions. The main outcome was a reduction greater than or equal to 25% from the baseline of the degree of adenoid and/or tonsillar hypertrophy. RESULTS: In the intention-to-treat analysis, a reduction of the degree of adenoid and/or tonsillar hypertrophy ≥25% from baseline after 10 therapy sessions was found in 44.4% of the patients in the halotherapy arm and in 22.2% of the patients in the placebo arm (P=0.204). Among the secondary outcomes, the reduction of hearing loss after 10 treatment sessions in the halotherapy arm was higher than the placebo arm (P=0.018) as well as the time-dependent analysis showed significantly improved peak pressure in the Aerosal group (P=0.038). No side effects were reported during the trial. In addition, the therapy was well accepted by the young patients who considered it as a time for play rather than a therapy. CONCLUSIONS: Aerosal halotherapy can be considered a viable adjunct, albeit not a replacement, to conventional medical treatment of sub-obstructive adenotonsillar syndrome and related conditions. Further research is however needed to improve ATH treatment.

When sneezing indicates the cell type.

BACKGROUND: Nasal hyperreactivity is the symptomatic expression of vasomotor rhinitis. This study describes a typical nasal reaction, represented by a "volley of sneezes" found in some patients during nasal endoscopy, and to assess the possible correlation between hyperreactivity and a particular clinical and cytological condition. METHODS: We studied 671 rhinological subjects, 344 male, mean age 35.7 ± 13.76 standard deviation (SD) years. All were submitted to medical histories and clinical and instrumental investigations (skin prick test, nasal endoscopy, and nasal cytology). While performing endoscopy, particular attention was paid to the possible signs of nasal hyperreactivity, in particular "volley of sneezes" both during and immediately after the diagnostic procedure. RESULTS: Out of 671 endoscopies performed, 130 (17.1%) patients presented signs of hyperreactivity during and/or immediately after nasal endoscopy. The ratio of positive vasomotor reaction was 10.6% in the nasal polyposis (NP) group, 19% in the allergic rhinitis (AR) group, 70.6% (p < 0.01) in nonallergic rhinitis with mast cells (NARMA), 76% (p < 0.01) in nonallergic rhinitis with eosinophils and mast cells (NARESMA), and 83% (p < 0.01) in nonallergic rhinitis with eosinophils (NARES). In the AR subjects hyperreactivity was more frequent during the pollen season, compared to the period of absence of pollen (87.5% vs 12%). CONCLUSION: The onset of hyperreactivity (sneezing) can be considered an important "sign" in nasal symptomatology, whose sensitivity and specificity for nonallergic "cellular" rhinitis are 79% and 93%, respectively.

Nasal resistance and allergic inflammation depend on allergen type.

BACKGROUND: Allergic rhinitis is characterized by inflammatory cell infiltrate and increased nasal airflow resistance. OBJECTIVE: The aim of this study was to evaluate the relationship between sensitization type, inflammatory cell pattern, and nasal airflow resistance in a group of rhinitics with monosensitization. METHODS: Seventy-seven subjects (40 males and 37 females, with a mean age of 33 +/- 4.4 years) suffering from allergic rhinitis were studied. Skin prick test, nasal cytology and electronic rhinomanometry were assessed in all subjects. RESULTS: The number of subjects monosensitized to house dust mites was 23, to grasses 20, to cypress 17, to Parietaria 11, and to olive tree 6. Significant differences were observed between each type of allergen sensitization concerning both the nasal airflow resistance (p = 0.002) and the nasal cytology pattern: eosinophils (p = 0.004), degranulated eosinophils (p = 0.002), mast cells (p = 0.006) and degranulated mast cells (p = 0.008). Furthermore, goblet cells were higher in house dust mite-sensitized subjects compared with the pollen-sensitized group (p = 0.018), in which a prevalence of eosinophils, degranulated eosinophils, mast cells and degranulated mast cells was observed (p = 0.049, p < 0.001, p = 0.022 and p = 0.007, respectively). Nasal resistances were higher in the pollen group (p = 0.001). CONCLUSIONS: This study provides evidence that inflammatory cell pattern and nasal resistance depend on the type of allergen sensitization.