Antonio Scordamaglia

a three-year double-blind placebo-controlled study with specific oral immunotherapy to Dermatophagoides : evidence of safety and efficacy in paediatric patients

Very few double‐blind trials of oral immunotherapy have been reported. The majority of these have been performed with pollen extracts and the results have often been equivocal. The major weaknesses of these studies have been the short periods of the trials, the low doses of allergen employed and inadequate evaluation of efficacy. The present study has involved a placebo‐controlled double‐blind trial of oral immunotherapy for three years with Dermatophagoides pteronysstnus at relatively high doses in 18 paediatric patients. Throughout the trial clinical parameters (symptom and medication scores) and immunological parameters (specific IgE, IgG1 and IgG4 levels) were monitored in order to assess the safely and efficacy of the treatment. The treatment was well tolerated by all patients and no side‐effects were experienced. Clinical improvement was evident after the second year of therapy and this was confirmed by a significant reduction in conjunctiva! reactivity assessed by a specific conjunctival provocation lest. In addition, there were significant changes in the immunological parameters with a reduction in specific IgE and increased levels of IgG4 and IgGI, results in keeping with previous studies of oral and subcutaneous immunotherapy. Although the results do not provide an explanation of the basis of successful oral immunotherapy, they clearly demonstrate the efficacy and safety of the treatment and suggest that it may be a useful and more acceptable alternative for patients than the traditional subcutaneous immunotherapy.

Long-term follow-up of nasal immunotherapy to Parietaria: clinical and local immunological effects

Background Local nasal immunotherapy (LNIT) with extracts in powder has been detnonstrated clinically effective and devoid of side‐effects in several controlled trials; nevertheless, no data concerning the long‐term effects of LNIT are presently available.

Total and Specific IgE in Serum, Bronchial Lavage and Bronchoalveolar Lavage of Asthmatic Patients

Total and specific IgE were assessed in serum, bronchial lavage (BL) and broncho‐alveolar lavage (BAL) of allergic asthmatics and healthy controls. Serum total IgE were found to be correlated with total IgE in BAL but not in BL. Total IgE/K+ ratio in serum and BL was higher in asthmatics than in controls, while the total IgE/albumin ratio was significantly higher in asthmatics than in controls in serum but not in BL and BAL. The mean of specific IgE in serum and BL was significantly higher in the group of patients with positive specific bronchial provocation test (sBPT) than in the group with negative sBPT. Similar results were observed between specific IgE serum level and BL and prick tests (PT). which show that BL does not always reflect the total IgE level of serum; in asthmatics, albumin can not be used to determine the degree of dilution in the recovered fluids; as in the serum, there is agreement between specific IgE in BL and PT or sBPT results.

Levocetirizine in persistent allergic rhinitis: continuous or on-demand use? A pilot study

ABSTRACT Background: Allergic rhinitis is a high-prevalence disease that affects quality of life (QOL), sleep quality and productivity of patients. According to the ARIA initiative, it is classified as intermittent and persistent, the latter being the most troublesome. Methods: The aim of this randomized, open-label, 6-month, pilot study was to determine whether levocetirizine 5 mg administered continuously once daily in the morning was better than levocetirizine 5 mg on-demand in symptomatic subjects with persistent allergic rhinitis. Total and individual symptom scores were recorded in a diary card throughout the study. QOL, quality of sleep, nasal cytology, rate of drug intake, and safety were also assessed at pre-defined time-points. Results: In all, adult patients (31 in each group) were enrolled, of whom 22 dropped out. Both treatment regimens considerably decreased the total and individual symptoms scores from baseline and achieved similar levels up to week 14. Continuous treatment was generally better than on-demand from week 15 onwards, reaching statistical significance from weeks 17 to 21 (from week 19 to 21 for nasal pruritus). Both regimens substantially improved QOL and sleep quality. Both treatments were well tolerated, although the on-demand group reported more adverse events. Conclusion: The present open label study in 62 patients indicates that levocetirizine 5 mg reliably controls persistent rhinitis over a period of 6 months, and shows a trend to be more effective in controlling the symptoms of rhinitis, improving QOL and decreasing nasal inflammation, when administered as long-term continuous therapy rather than as on-demand therapy.

Fibrous invasive (Riedel's) thyroiditis with critical response to steroid treatment.

The Riedel’s thyroiditis is an uncommon form of chronic thyroiditis characterized by an invasive fibrosclerosis of the gland, often involving the surrounding tissues. Usually, the only possible treatment is the surgical decompression of the tissues. We describe a case of aggressive Riedel’s thyroiditis with severe compression and dislocation of thrachea and esophagus. The surgical approach was uneffective, while an “ex juvantibus” steroid treatment, resulted in a dramatic regression of fibrosclerosis and a complete clinical remission. This report points out the possible effectiveness of corticosteroids in the treatment of selective disorders involving increased fibrogenesis.

Pitfalls in Respiratory Allergy Management: Alexithymia and Its Impact on Patient-Reported Outcomes

Objectives. Alexithymia is a personality trait characterized by a limited ability to identify and express emotions and it represents a possible risk factor for disease development and management. The objective of the study is to evaluate alexithymia in patients with persistent asthma and comorbid rhinitis and its relation with patient-reported outcomes (PROs). Methods. Alexithymia, quality of life, illness perception, and stress were assessed, as well as rhinitis symptoms and asthma control in out-patients classified according to GINA and ARIA guidelines. Results. Out of 115 patients, 19% turned out to be alexithymic (TAS-20 ≥ 61). Concerning alexithymia level, no difference was detected between males and females (χ2 = 0.317) and among GINA levels (χ2 = 0.22). Alexithymics had significantly lower Asthma Control Test scores when compared with non-alexithymics (15.86 vs. 19; p = .02). Alexithymics had a worse quality of life (p< .001) and, concerning illness perception, they ascribed to respiratory allergy symptoms that are not strictly disease related and referred to asthma and rhinitis more serious negative consequences (p < .001) and emotional representations (p < .035). Moreover, they had lower illness coherence (p < .001) and lived their disease as a cyclical rather than a chronic disorder (p < .035). As regards stress, alexithymics reported less energy (p < .001), higher levels of tension (p < .001), depression (p < .001), confusion (p > .001), and inertia (p < .001). Conclusion. Alexithymia is present in a relevant percentage of subjects and, as it can modulate illness perception, quality of life, and stress, it should be considered in disease management.

Molecular events in allergic inflammation: experimental models and possible modulation

In recent years, a complex molecular network involving cytokines kinins and adhesion molecules has been demonstrated to operate in allergic inflammation. In particular, the adhesion machinery plays a crucial role for the recruitment and locomotion of the inflammatory cells and the Intercellular Adhesion Molecule 1 (ICAM‐1) is a hallmark of the allergic inflammatory process. The role and possible modulation of ICAM‐1 can be investigated using both eye and nose experimental models. Conjunctiva and nasal epithelium are easy to study either under natural allergen exposure or after specific/aspecific provocation tests; furthermore the nasal/conjuctival challenge is well tolerated by the patients. These experimental models have allowed us to investigate in vivo the antiallergic properties of several compounds. Many of the new antihistamines, but also deflazacort and local nasal immunotherapy, were demonstrated capable of reducing both inflammatory infiltration and ICAM‐1 expression on epithelia. Because of the central role of adhesion molecules in allergic inflammation, their pharmacological modulation can be regarded as a promising therapeutic approach.

Inhibition of adhesion molecules by budesonide on a human epithelial cell line (lung carcinoma)

Inhaled corticosteroids in the treatment of asthma have been shown to produce marked reductions in the number of inflammatory cells (mainly mast cells and eosinophils) and their products at bronchial level (such as cytokines). Recently, it has been demonstrated that epithelial cells express ICAM‐1/CD54 in allergic patients both during natural allergen exposure and after allergen challenge. We have previously demonstrated that deflazacort (a systemic steroid) reduces the expression of ICAM‐1 on conjunctival epithelial cells. The present study aimed to evaluate the effects exerted by budesonide on adhesion molecule expression by a human epithelial cell line (lung carcinoma: DM) and on soluble ICAM‐1. Budesonide was added at concentrations corresponding to 10−8, 10−7, and 10−6 mol/1 in cultured epithelial cells, either in the absence of any stimulus or in the presence of interferon‐gamma (IFN‐y) at 500 U/ml. After 24 h of incubation, cytofluorometric analysis was performed for ICAM‐1 and CD29/VLAP1. The 24–h supernatants of the same cultures were collected and then evaluated for soluble ICAM‐1 (sICAM‐1). The results showed that budesonide inhibits ICAM‐1 and CD29 basal expression on the cells studied (P<0.05): budesonide was effective in a dose‐dependent manner. In addition, budesonide reduced surface ICAM‐1 upregulation induced by IFN‐γ at 500 U/ml (p<0.05). Finally, cell cultures with budesonide showed decreased levels of soluble ICAM‐1 in basal condition, but not after IFN‐γ stimulation.

Single-dose oral tolerance test with alternative compounds for the management of adverse reactions to drugs.

Background: Adverse reactions to drugs are common in the clinical practice. Many outpatients are frequently referred to allergists in order to determine which drugs they can safely take in the future. Objective: We set up an oral single-dose tolerance test procedure to find out for each patient one or more alternative drugs that can be taken when needed. Methods: 452 outpatients (130 male, 322 female) with well-documented reactions (urticaria/angioedema, respiratory symptoms, laryngeal edema, anaphylaxis, exfoliative skin diseases) underwent the challenge. All tests were preceded by a single-blind placebo: if a reaction occurred, a second placebo was administered. Otherwise, a single dose (1/10 of the therapeutic one) of an alternative drug was given blindly and the patient was then observed for 6 h. The drugs used were different in structure from those suspected of having caused the adverse reaction. The patients were followed up at 4- to 6-month intervals, in order to detect any reaction that may have occurred with the tested drugs. Results: 98 patients (89 women) had untoward reactions after the first placebo and 34 out of them reacted to the second placebo, too. During challenges the reaction rate ranged between 4.6 and 9.0%; these reactions were easily managed and none of them was severe. We followed up 407 patients: 87.2% of them were able to use one or more of the suggested drugs without reactions, 9.3% did not take the drugs and only 3.5% reported reactions to the previously tested drugs. Conclusion: The challenge procedure proved to be a simple tool for managing patients with adverse reactions to drugs. Its safety and reliability were validated by a long-term follow-up.

Aeropollinic sampling at three different heights by personal volumetric collector (Partrap FA 52)

Background: Aeropollinic sampling is usually performed by volumetric pollen traps located on the top of buildings at a height of 15–20 m. The present study aimed to determine whether pollen concentration is similar, at the same time, at different heights.