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Background: Sublingual immunotherapy (SLIT) allergy vaccines have an excellent safety profile, but opinions vary on their efficacy, and treatment regimens are often lengthy. This study assessed the effects of the Toll-like receptor 4 agonist monophosphoryl lipid A (MPL®) on safety/tolerability and clinical and immunological efficacy when combined with grass pollen SLIT formulations in treating patients with seasonal allergic rhinitis. This is the first reported study of adjuvanted SLIT. Methods: In this double-blind placebo-controlled phase I/IIa study, 80 grass pollen-sensitive subjects were randomized into 4 groups of 20 subjects to receive daily treatment for 8 weeks. Sixteen patients per group received SLIT and 4 received placebo. The formulation given to each group varied with respect to grass pollen extract and MPL content. Grass allergen nasal challenge tests (NCTs) were performed prior to dosing and in weeks 4 and 10. Grass pollen-specific immunoglobulin G (IgG) and IgE antibodies were measured at baseline and prior to dosing in weeks 2, 3, 4, 5 and 10. Results: Local and systemic adverse events were generally comparable for patients who received active treatment and placebo. Patients in the 2 groups given SLIT containing the highest amount of MPL experienced the highest proportion of negative NCTs after 10 weeks (47 and 44%, vs. 20% with placebo). These patients also showed earlier median increases in specific IgG and smaller increases in IgE levels than those receiving other formulations. Conclusions: These results suggest that SLIT preparations containing MPL are well tolerated and alter the immunological response to grass antigens after 3 weeks of exposure, with an associated suppression of nasal challenge responses.

Specific immunotherapy is a well-established treatment for allergic rhinoconjunctivitis; conventional regimens are lengthy, however, reducing convenience and cost-effectiveness. This study evaluated the efficacy and safety of an ultrashort course (four doses) of the immunotherapy Grass Modified Allergen Tyrosine Adsorbate (Allergy Therapeutics, Worthing, U.K.) monophosphoryl lipid A (MATA MPL). Subjects were randomized to receive four injections of either Grass MATA MPL (n = 514; 300-2000 standardized units/injection) or placebo (n = 514) before the grass pollen season. They used electronic diaries to record allergy symptoms and medication use during the pollen season. The primary end point was the difference between the mean combined symptom and medication scores in the Grass MATA MPL and placebo groups during the 4 local peak pollen weeks. The injection course was completed by 95.3 and 97.7% of the Grass MATA MPL and placebo groups, respectively, and was well tolerated. Grass MATA MPL treatment afforded a 13.6% benefit over placebo in the 4 peak pollen weeks (p = 0.0038). The benefit in subjects with 28 complete diary entries during the 4 peak pollen weeks was 24.3% (p = 0.0031). Significant benefits over placebo were observed in subjects with severe symptoms (16.6%; p = 0.0023), in those who had a history of allergic rhinoconjunctivitis for up to 35 years (up to 31%; p = 0.0059) and at sites with a higher burden of disease (31%; p < 0.0001). The ultrashort course of Grass MATA MPL was well tolerated and provided a significant benefit over placebo in relieving allergy symptoms.Corrected Version posted November 2011

Background: Climatic changes causing early pollen flight and new allergens prolonging the pollen season render up-dosing of allergen-specific subcutaneous immunotherapy (SCIT) outside the pollen season considerably more difficult. In addition, for patients with multiple pollen allergies, patients coming near the beginning of pollen season, and patients who wish to up-dose faster, an accelerated induction regimen would be helpful. Methods: In an open, randomized, parallel group, multicenter safety trial, an accelerated up-dosing regimen (0.1–0.3–0.5 ml in weekly intervals) was compared to conventional up-dosing (0.05–0.1–0.2–0.3–0.4–0.5 ml in weekly intervals) with an allergoid grass pollen SCIT preparation. After up-dosing, the maintenance dose was given in monthly intervals. Results: A total of 146 adult patients with rhinitis or rhinoconjunctivitis with or without mild asthma (FEV 1 >70%) due to grass pollen were randomized to either the conventional registered up-dosing or an accelerated regimen. In both groups (accelerated regimen, n = 69; conventional regimen, n = 75), a high proportion of patients (92.75 and 92.0%, respectively) successfully reached the maintenance dose without safety concerns. Furthermore, significant increases in specific IgG and IgG 4 after 4 months of treatment were observed in both groups. Conclusion: The accelerated SCIT regimen was found to be as safe as the conventional regimen and might be used to up-dose patients within 2 weeks. Moreover, the immunological effects of both up-dosing regimens were comparable.

CONTEXT : Terpenes and terpenoids are a diverse class of organic compounds produced by a variety of plants, particularly conifers. Chemically sensitive patients can be targeted by terpenes and terpenoids, resulting in a triggering of symptoms and pathology. Often patients cannot clear their symptoms from exposure to chemicals unless terpenes and terpenoids are avoided and neutralized along with chemical avoidance and treatment. This article evaluates the presence, diagnosis, and treatment of terpenes exposure in chemically sensitive patients. A double-blind, placebo-controlled, 2-part study was designed to establish the chemically sensitive state of the patients in part 1, followed by a second set of challenges to determine each patient's concurrent sensitivity to terpenes and terpenoids in part 2. In all of the challenges, normal saline was used as a control. A case report illustrates the history of 1 patient and describes the authors' treatment methods. The study was developed and conducted at the Environmental Health Center of Dallas (EHC-D) because the environment within the center is 5 times less polluted than the surrounding environments, as determined by quantitative air analysis and particulate counts. A total of 45 chemically sensitive patients at EHC-D with odor sensitivity to terpenes. The cohort included 18 males and 27 females, aged 24-62 y.Intervention • Patients were deadapted (4 d) and evaluated in a 5-times-less-polluted environment, which was evaluated using air analysis and particulate counts. After deadaptation, the patients were challenged by inhalation in a controlled, less-polluted glass steel booth inside an environmentally controlled room with an ambient air dose of the toxics in the order of parts per billion (PPB) and parts per million (PPM). These toxics included formaldehyde, pesticide, cigarette smoke, ethanol, phenol, chlorine, new sprint, perfume, and placebo. They were also challenged intradermally with extracts of volatile organic compounds (VOCs), including formaldehyde, orris root, ethanol, phenol, cigarette smoke, chlorine, newsprint, perfume, terpenes, terpenoids, and placebo. Inhaled challenges recorded pulse, blood pressure, peak bronchial flow, and other signs and symptoms 30 min before and at 15-min intervals for 2 h postchallenge. Intradermal challenges recorded wheal size and the provocation of signs and symptoms. RESULTS : Different numbers of patients were tested for each terpenes source because of time-related factors or the cumulative effect of testing, which made patients unable to continue. Of 45 chemically sensitive patients in the study, 43 demonstrated sensitivity to terpenes. This particular patient group was positive for a number of toxic and nontoxic chemicals provoking their symptoms. This study shows there was a connection between VOCs, other chemicals, and terpenes in chemically sensitive patients in a prospective cohort study. It has also shown the potential for terpenes to exacerbate symptoms of chemical sensitivity. Further research on this topic is recommended.

Objective Specific immunotherapy is the only treatment for the underlying allergic disease in patients with respiratory allergies. The primary objective of this trial was to evaluate the efficacy and safety of two maintenance doses of immunologically enhanced, standardised quality (SQ+) grass subcutaneous immunotherapy (SCIT) [4,000 SQ+ and 15,000 SQ+; AVANZ ® Phleum pratense (ALK)] compared with placebo. Methods This was a randomised, double-blind, placebo-controlled, phase II/III trial. The primary evaluation was based on the combined rhinoconjunctivitis score during the entire grass pollen season. Adult subjects with grass pollen-induced allergic rhinoconjunctivitis interfering with usual activities or sleep despite symptomatic medication use, were enrolled. Results Four hundred and fifty subjects were randomised to receive either 4,000 SQ+ ( n  = 150), 15,000 SQ+ ( n  = 152) or placebo ( n  = 148). The average grass pollen exposure was 27 grains/m 3 /day. No statistically significant differences between the active groups and the placebo group were found for clinical endpoints ( p  > 0.05). Highly statistically significant ( p  < 0.001) increases in IgG 4 and IgE-blocking factor were found for both active groups versus placebo. The most frequently reported adverse events were mild-to-moderate local injection-site reactions; events were generally more frequent with 15,000 SQ+ than with 4,000 SQ+ and placebo. The most common adverse events leading to premature discontinuation from the trial were anaphylactic reactions (one subject from the placebo group and five subjects from the 15,000 SQ+ group). Conclusions The inconclusive results were most probably influenced by a very low grass pollen season. Other factors such as the extent of the pre-seasonal treatment could potentially have contributed. The tolerability profile was acceptable for further development.

Background: Only a few randomized controlled trials have been carried out to evaluate various complementary treatments for allergic disorders. This study assessed the effects of the preseasonal use of birch pollen honey (BPH; birch pollen added to honey) or regular honey (RH) on symptoms and medication during birch pollen season. Methods: Forty-four patients (59% female, mean age 33 years) with physician-diagnosed birch pollen allergy consumed either BPH or RH daily in incremental amounts from November 2008 to March 2009. Seventeen patients (53% female, mean age 36 years) on their usual allergy medication served as the control group. From April to May, patients recorded daily rhinoconjunctival and other symptoms and their use of medication. Fifty patients completed the study. Results: During birch pollen season in 2009, BPH patients reported a 60% lower total symptom score (p < 0.01), twice as many asymptomatic days (p < 0.01), and 70% fewer days with severe symptoms (p < 0.001), and they used 50% less antihistamines (p < 0.001) compared to the control group. The differences between the BPH and RH groups were not significant. However, the BPH patients used less antihistamines than did the RH patients (p < 0.05). Conclusions: Patients who preseasonally used BPH had significantly better control of their symptoms than did those on conventional medication only, and they had marginally better control compared to those on RH. The results should be regarded as preliminary, but they indicate that BPH could serve as a complementary therapy for birch pollen allergy.

To establish the optimal dose of subcutaneous immunotherapy (SCIT) in patients with allergic rhinoconjunctivitis with/without asthma. One hundred and fifty-one patients were randomized to receive SCIT 0.25, 0.5, 1.0, 2.0 or 4.0 skin-prick test units ( or placebo. The primary end point was the variation in the concentration of extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). After 17 weeks, a dose-dependent trend was apparent in the concentration of extract needed to produce a positive nasal provocation response. Systemic adverse reactions occurred with 3.2% of administered doses. Grade III (n = 2) and IV (n = 2) events were observed only at the two highest doses. : depot SCIT showed signs of clinical and immunological efficacy by dose-dependently decreasing the allergen sensitization rate. Risk-benefit favored doses below 1.0 units for confirmatory trials.

Specific local immunotherapy has been recently introduced as an alternative to classic subcutaneous immunotherapy in treatment of allergic rhinitis. In this study, the effects of sublingual immunotherapy (SLIT) on symptoms and medication score and skin prick test evaluation of patients with allergic rhinitis were investigated.In this placebo controlled trial, twenty four patients aged 5-18 years old with grass pollen induced rhinitis and sensitive to rye grass by positive skin prick test received randomly sublingual extract of rye grass or placebo for 6 months. Symptom and medication scores and adverse effects of SLIT were assessed during treatment. Skin prick test induced wheal at the beginning and the end of therapy were also measured. Data were analyzed with SPSS software.We found significant reduction of symptoms in intervention group from 21st week of immunotherapy (p<0.05). Medication scores were also reduced after 16th week (p<0.05), adverse effects were low and insignificant in both groups. Erythema induced diameter with skin prick test for grass and rye grass was significantly reduced in SLI group after immunotherapy.This study indicates that SLIT in grass-pollen rhinitis is well tolerated, improves overall clinical symptoms, and reduces drug consumes. We recommend this therapy as a safe therapy in patients with allergic rhinitis.

The safety and efficacy of high-dose sublingual-swallow immunotherapy (SLIT) has been established in pollen rhinoconjunctivitis. This treatment has now been evaluated using an ultra-rush incremental dose regimen with a Juniperus ashei allergen extract in patients allergic to Cupressus sempervirens and Cupressus arizonica. Patients received either placebo or SLIT. Evaluation of safety was based on the frequency of adverse events during the incremental dose period (half a day) and during maintenance therapy (4 months). Evaluation of efficacy was based on symptom and medication scores at the pollen peak. Seventy of the 76 patients included completed the study. There were no drop-outs during the rush procedure. One patient in the active group dropped out during the maintenance therapy due to adverse events: gastric pain and vomiting. There was also 1 drop-out in the placebo group due to pregnancy. Adverse events were infrequent, local and mild. Symptom scores for rhinitis and conjunctivitis were not statistically different between groups, but there was a marked and significant (p < 0.03) decrease of the medication score (about 50%) and nasal steroid consumption (about 75%) in the active treatment group. An increase from baseline of serum IgE and IgG4 J. ashei-specific antibodies was only observed in actively treated patients (p < 0.04 and p < 0.01, respectively). The tolerability and safety of high-dose ultra-rush SLIT were comparable to those reported in previous SLIT studies. SLIT with J. ashei extract, due to its high Jun a 1 content, significantly reduced nasal steroid consumption in patients allergic to European cypress.

Sublingual immunotherapy (SLIT) with monomeric carbamylated allergoid administered in accordance with the standard regimen has proven to be effective and safe. Achieving clinical benefit, however, requires a lengthy period of time so it is not very suitable for short-lasting allergies. We thus performed this study to compare an administration protocol starting in the coseasonal period (with a 4-day build-up phase) with a precoseasonal scheme to verify if the former regimen provides the same benefit in a shorter period of time. The prospective, randomized, drug therapy-controlled study was conducted in 33 rhinitic patients monosensitized to Olea with or without asthma. Ten patients were assigned to the coseasonal therapy with 5000 allergic units (AU)/week for 6 weeks, 11 to the precoseasonal therapy with 3000 AU/week for 10 weeks, and 12 to drug therapy. They were treated from April or May to June 2008. A visual analog scale (VAS) was performed at baseline and after treatment to assess the well being of the patients. Drug consumption was evaluated by means of a monthly diary. There was greater VAS improvement in both the SLIT groups versus the controls, but it was statistically significant only in the coseasonal group (p < 0.01). Furthermore, there was a reduction in the rescue medication only in the coseasonal SLIT (p < 0.05 versus drug therapy). One mild adverse event was observed. The allergoid SLIT was shown to be effective and safe in Olea allergy in particular when a coseasonal regimen was used.