Airways Register Search update 2008-Sept 2010

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Airways Register Search update 2008-Sept 2010

1. Agostinis F, Foglia C, Bruno ME, Falagiani P (Pediatric Division, Ospedali Riuniti, Bergamo.). Efficacy, safety and tolerability of sublingual monomeric allergoid in tablets given without up-dosing to pediatric patients with allergic rhinitis and/or asthma due to grass pollen. , English. European Annals of Allergy & Clinical Immunology 2009 Dec;41(6):177-80.
Keywords: AIRWAYS ID: AST/ Administration, Sublingual/ Adolescent/ *Asthma/ th [Therapy]/ Child/ Desensitization, Immunologic/ ae [Adverse Effects]/ *Desensitization, Immunologic/ Female/ Humans/ Male/ *Plant Extracts/ ad [Administration & Dosage]/ *Poaceae/ im [Immunology]/ *Pollen/ im [Immunology]/ Prospective Studies/ *Rhinitis, Allergic, Perennial/ th [Therapy]/ *Rhinitis, Allergic, Seasonal/ th [Therapy]/ Tablets
Notes: PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Randomized Controlled Trial
Abstract: The efficacy and safety of monomeric allergoid (Lofarma, Milan) have been demonstrated in adults but very few studies have examined it in children. This study therefore investigated the efficacy and safety of this sublingual immunotherapy (SLIT) at the dosage of 1000 AU five times a week without any up-dosing. Forty allergic children (17 M and 23 F, mean age 7 years, range 4-16 years), 16 with rhinitis and 24 with rhinitis and asthma, were randomized to SLIT or drug therapy. All the patients were sensitized to grass; some were also sensitized, though to a lesser extent, to Parietaria, Olea and Betulaceae. The patients were treated pre-/co-seasonally for two years. A visual analogue scale (VAS) was used at baseline and at the end of the first and second pollen seasons to rate the patients' well-being. The VAS score was significantly higher after both the first and the second year of treatment in the SLIT group than in the controls (p<0.05). It improved in comparison to baseline only in the active group. All 40 children tolerated the therapy very well. The monomeric allergoid at the dosage of 5000 AU/week thus appears to have a good efficacy and safety profile in children.

2. Aldana D, Prieto L, Palacios R, Perez-Frances C, Ferrer A, Lopez V et al. Allergen-specific Immunotherapy with Purified nAlt a1: Effects on AMP Responsiveness, Exhaled Nitric Oxide and Exhaled Breath Condensate pH [Abstract]. doi: DOI: 10.1016/j.jaci.2009.12.480. Journal of Allergy and Clinical Immunology 2010;125(2 Suppl 1):AB122.
Keywords: AIRWAYS ID: AST/ asthma; allergic rhinitis

3. Antonova LP, Romanov VV, Averbakh MM. [Experience with bronchomunal used in the combined treatment of patients with bronchial asthma and chronic obstructive pulmonary disease]. [Russian]. Problemy Tuberkuleza I Boleznej Legkih 2008; (4):8-11.
Keywords: AIRWAYS ID: AST/ COPD/ *Adjuvants, Immunologic/ tu [Therapeutic Use]/ Antibodies, Anti-Idiotypic/ an [Analysis]/ *Asthma/ dt [Drug Therapy]/ Asthma/ im [Immunology]/ Bacteria/ *Cell Extracts/ tu [Therapeutic Use]/ Female/ Follow-Up Studies/ Humans/ Immunity, Cellular/ ph [Physiology]/ Immunoenzyme Techniques/ Immunoglobulins/ im [Immunology]/ Male/ *Pulmonary Disease, Chronic Obstructive/ dt [Drug Therapy]/ Pulmonary Disease, Chronic Obstructive/ im [Immunology]/ T-Lymphocytes/ de [Drug Effects]/ T-Lymphocytes/ im [Immunology]/ Treatment Outcome
Notes: PUBLICATION TYPE: Comparative Study
PUBLICATION TYPE: English Abstract
Abstract: The paper presents the results of treatment in 30 patients aged 16-59 years who have bronchial asthma and chronic obstructive pulmonary disease, by using a bacterial vaccine (bronchomunal) containing antigens of opportunistic bacteria: Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Streptococcus viridans, Streptococcus piogenes, Moraxella catarrhalis. Immunotherapy with the vaccine had good and excellent effects in 73.33 of cases; the mean duration of acute respiratory viral infection decreased from 16 to 9 days after vaccination and a need for antibiotics. In the comparison group, a good effect was noted in 40% of the patients during one-year follow-up; the difference was statistically significant. The vaccine's tolerance was good; only 3 (9.9%) patients were observed to have vaccination-induced complications: exacerbations of chronic maxillary sinusitis and chronic bronchitis in 2 and 1 patients, respectively. The positive effect of bronchomunal was associated with the better values of cellular immunity, stabilized phagocytosis, and lower IgE levels.

4. Ariano R, Incorvaia C, La Grutta S, Marcucci F, Pajno G, Sensi L, Di Cara G, Sieber J, Yacoub MR, Frati F (Allergy Department, ASL1 Imperiese, Bordighera, Italy.). Safety of sublingual immunotherapy started during the pollen season. Current Medical Research & Opinion 2009 Jan; 25(1):103-7.
Keywords: AIRWAYS ID: AST/ Administration, Sublingual/ Adolescent/ *Allergens/ ad [Administration & Dosage]/ *Asthma/ th [Therapy]/ Child/ Child, Preschool/ *Desensitization, Immunologic/ ae [Adverse Effects]/ Humans/ *Pollen/ *Rhinitis, Allergic, Seasonal/ th [Therapy]
Notes: PUBLICATION TYPE: Journal Article
PUBLICATION TYPE: Research Support, Non-U.S. Gov't
Abstract: BACKGROUND: Sublingual immunotherapy (SLIT) is safer than subcutaneous immunotherapy (SCIT) and this has lead to the reconsideration of the use of ultra-rush schedules for SLIT. The aim of this study was to assess the safety of ultra-rush SLIT in pollen-allergic children according to different timing of administration in relation to the pollen season. METHODS: In total, 34 children with pollen-induced rhinitis and 36 with pollen-induced asthma and rhinitis, were enrolled and assigned to three study groups: group 1 (n = 17 patients): conventional pre-seasonal-SLIT treatment; group 2 (n = 23 patients), seasonal SLIT ended before the pollen seasonal peak; group 3 (n = 30 patients), SLIT began after the pollen seasonal peak and ended after the pollen season. SLIT was performed using extracts from Stallergenes (Antony, France) and following an ultra-rush schedule, consisting in four doses at a 30-min intervals, and maintenance treatment by administering the top dose three times a week. RESULTS: In all, 54 adverse events (AEs) were reported: 12 in nine patients in group 1 (9/17, 52.9%), 22 in 14 patients in group 2 (14/23, 60.9%), and 20 in 13 patients in group 3 (13/30, 43.3%). No statistically significant differences were found between the three groups. Local AEs (oral itching and burning) were short lasting and self-resolving. Systemic AEs were also mild, except for a case of asthma, which lasted 5 days, in a patient from group 1. There were no severe reactions, and none of the patients dropped out. CONCLUSIONS: This study suggests that SLIT with pollen extracts may be safely started at the beginning and also during the pollen season, with a tolerability profile comparable to the conventional pre-seasonal SLIT.

5. Armentia-Medina A, Tapias JA, Martín JF, Ventas P, Fernández A. Immunotherapy with the storage mite lepidoglyphus destructor [Immunotherapy with the storage mite lepidoglyphus destructor]. CN-00662688. Allergologia Et Immunopathologia 1995;23(5):211-23.

6. Blaziene A, Leisyte P, Sitkauskiene B, Kits L, Savisaar M, Lozovskis V, Bukovskis M, Maurer P, Willers J, and Mueller P. Cyt003-Qbg10, a novel allergen-independent immunotherapy, shown to be safe and efficacious for treating allergic rhino-conjunctivitis and asthma in placebo-controlled phase II study. CN-00725130. Allergy 2009;64(s90):74 [159].

7. Bochenska-Marciniak M, Tworek D, Kupczyk M, Bogacka E, Kuprys-Lipinska I, Kuna P. The effectiveness of allergen immunotherapy depending on the regimen on rhinoconjunctivitis and asthma symptoms in allergy to grass pollen [Abstract]. American Thoracic Society International Conference, May 15-20, 2009, San Diego 2009; A2781 [Poster #J50].
Keywords: AIRWAYS ID: AST/ asthma

8. Bufe A, Eberle P, Franke-Beckmann E, Funck J, Kimmig M, Klimek L, Knecht R, Stephan V, Tholstrup B, Weisshaar C, et al. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. CN-00666110. The Journal of Allergy and Clinical Immunology 2009;123(1):167-73.e7.
Keywords: AIRWAYS ID: AST/ Adolescent; Antigens, Plant [administration & dosage] [adverse effects]; Asthma [immunology] [therapy]; Conjunctivitis, Allergic [immunology] [therapy]; Double-Blind Method; Immunotherapy; Poaceae [adverse effects] [immunology]; Pollen [adverse effects] [immunology]; Rhinitis, Allergic, Seasonal [immunology] [therapy]; Time Factors; Child; Child, Preschool; Female; Humans; Male
Notes: Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial
Abstract: BACKGROUND: Immunotherapy with the SQ-standardized grass tablet Grazax is efficacious and well-tolerated in adult patients with rhinoconjunctivitis. Allergic asthma and rhinoconjunctivitis are closely linked, and a strategy combining treatment of the upper and lower airways is recommended. OBJECTIVE: To investigate the efficacy of treatment with the grass tablet on grass pollen-induced rhinoconjunctivitis and asthma as well as the immunologic response and the safety profile in children. METHODS: A total of 253 children age 5 to 16 years, with grass pollen-induced rhinoconjunctivitis with/without asthma, were randomized 1:1 to active treatment or placebo. Treatment was initiated 8 to 23 weeks before the start of the grass pollen season 2007 and continued throughout the entire season. Symptomatic medication was provided as relief medication to both groups in a stepwise fashion. Primary endpoints were rhinoconjunctivitis symptom and medication scores. RESULTS: The rhinoconjunctivitis symptom and medication scores and the asthma symptom score were all statistically significantly different between the 2 treatment groups. The differences in medians relative to placebo were 24%, 34%, and 64% in favor of active treatment. The immunologic response was similar to that observed in adults. The most common adverse reaction was oral pruritus, reported by 40 subjects (32%) in the active and 3 (2%) in the placebo group. Six subjects withdrew because of adverse events. No serious adverse events were assessed as treatment-related. CONCLUSION: Immunotherapy with the grass tablet reduced grass pollen-induced rhinoconjunctivitis and asthma symptoms in a pediatric population and introduced an immunomodulatory response, consistent with treatment of the underlying allergic disease. The treatment was well tolerated.

9. Bush R, Swenson C, Fahlberg B, Bernstein J, Gaworski K, Sanchez H, Esch R, and Busse W. Safety of sublingual house dust mite (HDM) immunotherapy: a randomized, double-blind, placebo-controlled U.S. trial. CN-00691452. Journal of Allergy & Clinical Immunology 2009;123(2 Suppl 1):Abstract No. 273.
Abstract: American Academy of Allergy, Asthma and Immunology (AAAAI) 65th Annual Meeting, March 13-17, 2009, Washington, USA

10. Bush R, Swenson C, Fahlberg B, Bernstein J, Gaworski K, Sanchez H, Esch R, Busse W. Safety of Sublingual House Dust Mite (HDM) Immunotherapy: A Randomized, Double-blind, Placebo-controlled U.S. Trial [Abstract]. doi: DOI: 10.1016/j.jaci.2008.12.255. Journal of Allergy and Clinical Immunology 2009;123(2 Suppl 1):S74.
Keywords: AIRWAYS ID: AST/ allergic rhinitis; asthma;
Abstract: American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting 2009

11. Cadario G, Ciprandi G, Di Cara G, Fadel R, Incorvaia C, Marcucci F, Marengo F, Puccinelli P, Sensi L, Strazzeri L, et al. Comparison between continuous or intermittent schedules of sublingual immunotherapy for house dust mites: effects on compliance, patients satisfaction, quality of life and safety. CN-00643393. International Journal of Immunopathology & Pharmacology 2008;21(2):471-3.
Abstract: Sublingual immunotherapy (SLIT) is indicated in the treatment of allergic rhinitis and asthma. However, an issue scantly investigated is the patients satisfaction and the consequent compliance. This study is aimed at evaluating the possible differences of SLIT administered continuously or intermittently on several parameters: clinical efficacy, Quality of Life (QoL), satisfaction, compliance and safety. Forty allergic patients were treated for 12 months. The treatment was carried out by sublingual administration of an allergen extract of a 50% mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae at 10 and 300 IR/ml concentrations. Patients were randomly treated continuously or intermittently (i.e. 2 month treatment alternate to 2 month suspension). Both schedules were significantly effective in reducing allergic symptoms and improving QoL. Compliance and satisfaction were good in both groups. Local and systemic reactions were few, self-resolving, and mild in both schedules. Intergroup analysis did not reveal any difference between the two groups regarding these parameters. In conclusion, this preliminary study provides the evidence that also intermittent SLIT is as effective and safe as traditional continuous treatment. In addition, compliance and satisfaction are super-imposable in the two groups.

12. Cao LF, Lu Q, Gu HL, Chen YP, Zhang Y, Lu M, Qian YQ, Li L, and Xu YP. Clinical evaluation for sublingual immunotherapy of allergic asthma and atopic rhinitis with dermatophagoides farinae drops. CN-00643395. Zhonghua Er Ke Za Zhi 2007;45(10):736-41.
Abstract: OBJECTIVE: To evaluate the safety and efficacy of sublingual immunotherapy with 'Dermatophagoides Farinae Drops' in D. farinae allergic asthma and/or rhinitis patients. METHODS: A 25-week double-blind, placebo-controlled, multi-centered trail was conducted in 278 children (aged 4 - 18 yr) with mite-induced asthma and/or rhinitis. Patients were randomly assigned to receive sublingual immunotherapy (SLIT) with 'Dermatophagoides Farinae Drops' (n = 139) or placebo (n = 139) for 25 weeks and the dosage and administration strictly followed the manufacturer's instructions. At the beginning of the 2nd, 3rd, 4th, 6th, 10th, 14th, 18th, 22nd week of the treatment, the patients were asked to accept follow-up visit, during the clinical trial all patients and parents were asked to keep a daily record of their asthma symptom scores, rescue medicine use, rhinitis symptom scores, morning and evening peak expiratory flow. Asthma symptom scores, reduction in use of rescue medicine, rhinitis symptom scores, lung function tests, skin sensitivity to mite, mite-specific immunoglobulin (Ig) E and IgG4, and quality of life and adverse effect were assessed during the study. RESULT: (1) Of the 278 children, 27 dropped out before the study completion. (2) After 25 weeks of treatment, the median variability of PEFR was -1.38 for SLIT group and -0.90 for the placebo (P < 0.05). (3) Besides, the mean variability of medicine score of asthma was -0.08 for SLIT group and 0.52 for the plcebo (P < 0.05). (4) The median variability of rhinitis symptom score was -1.96 for SLIT group and -1.03 for the placebo (P < 0.01). (5) The rescue medicine usage of SLIT reduced but did not show significant differences between SLIT and placebo. (6) After 25 weeks treatment, the increase of D. farinae specific IgE antibody of two groups were similar, while specific IgG4 increased significantly in SLIT compared to the patients in control one (P < 0.01); (7) No severe adverse events happened in the trial and the most-likely adverse events were mild asthma and local rash. CONCLUSION: Dermatophagoides Farinae Drops is safe and effective in treating allergic asthma and atopic rhinitis.

13. Chen Z G , Chen Y F , Li M , Ji J Z , Chen F H , Chen H (Department of Pediatrics, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. [Effects of Dermatophagoides pteronyssinus allergen-specific immunotherapy on the prognosis of asthmatic children]. [Chinese], Chinese. Nan Fang Yi Ke Da Xue Xue Bao = Journal of Southern Medical University 2009 Jun; 29(6):1179-81.
Keywords: AIRWAYS ID: AST/ Adolescent/ *Allergens/ im [Immunology]/ *Antigens, Dermatophagoides/ im [Immunology] / Asthma/ im [Immunology]/ *Asthma/ th [Therapy]/ Child/ Child, Preschool/ *Desensitization, Immunologic/ mt [Methods]/ Female/ Humans/ Interferon-gamma/ bl [Blood]/ Interleukin-4/ bl [Blood]/ Male/ Prognosis/ Respiratory Function Tests/ Th1 Cells/ im [Immunology]/ Th2 Cells/ im [Immunology]
Notes: PUBLICATION TYPE: Controlled Clinical Trial
PUBLICATION TYPE: English Abstract
PUBLICATION TYPE: Research Support, Non-U.S. Gov't
Abstract: OBJECTIVE: To investigate the effects of Dermatophagoides pteronyssinus allergen-specific immunotherapy (SIT) on the prognosis of asthmatic children. METHODS: Sixty-five children with established diagnosis of allergic asthma to dust mite were enrolled in this study, of whom 42 children received treatment with standardized SIT for 12 month and the other 23 served as the control group with inhaled corticosteroids according to Global Initiative for Asthma (GINA). The serum levels of interleukin-4 (IL-4) and interferon-gamma (IFN-gamma) were detected and the pulmonary functions examined before and after the one-year treatment in all the patients. RESULTS: After the one-year treatment with SIT, the asthmatic children showed obviously reduced serum levels of IL-4, significantly increased IFN-gamma levels and the IFN-gamma/IL-4 ratio (P<0.05), and markedly improved pulmonary functions (FVC, pre-FEV1% and pre-PEF%) (P<0.05). In the control group, the children exhibited significantly increased IFN-gamma levels and IFN-gamma/ IL-4 ratio (P<0.05) without obvious reduction of serum IL-4 levels or pulmonary function improvement (P>0.05). With comparable basic pulmonary functions in the two groups before the treatment, the children in SIT group showed significantly greater improvement in the pulmonary functions than those in the control group after the one-year treatment. CONCLUSION: The one-year treatment with SIT can significantly improve the pulmonary functions of children with allergic asthma, and this effect is attributed to the regulation of Th1/Th2 cell balance and inhibition of asthmatic airway remodeling by SIT.

14. Chen ZG, Li M, Chen YF, Ji JZ, Li YT, Chen W, Chen FH, Chen H (Department of Pediatrics, Third Hospital Affiliated to Sun Yat-sen University, Guangzhou, Guangdong, China.). Effects of dermatophagoides pteronyssinus allergen-specific immunotherapy on the serum interleukin-13 and pulmonary functions in asthmatic children., English. Chinese Medical Journal 2009 May 20; 122(10):1157-61.
Keywords: AIRWAYS ID: AST/ Adolescent/ Animals/ *Antigens, Dermatophagoides/ im [Immunology]/ Asthma/ bl [Blood]/ Asthma/ im [Immunology]/ *Asthma/ th [Therapy]/ Child/ Child, Preschool/ *Dermatophagoides pteronyssinus/ im [Immunology]/ Enzyme-Linked Immunosorbent Assay/ Female/ Humans/ *Immunotherapy/ mt [Methods]/ Interferon-gamma/ bl [Blood]/ Interleukin-13/ bl [Blood]/ Interleukin-4/ bl [Blood]/ Male
Notes: PUBLICATION TYPE: Clinical Trial
PUBLICATION TYPE: Research Support, Non-U.S. Gov't
Abstract: BACKGROUND: Airway remodeling is the specific pathological characteristics of asthma, which is related to the clinical symptoms, pulmonary function, and airway hyperreactivity. This study aimed at exploring the effects of dermatophagoides pteronyssinus allergen-specific immunotherapy (SIT) on the serum interleukin (IL)-13 and pulmonary functions in asthmatic children. METHODS: Fifty-eight pediatric asthma patients allergic to dust mite participated in this study. Thirty-five children received SIT with a standardized dermatophagoides pteronyssinus extract for one year (SIT group), and the other 23 children treated with inhaled corticosteroids (ICS group) according to the Global Initiative for Asthma (GINA) for one year. Serum levels of IL-13, IL-4 and interferon (IFN)-gamma were examined and the pulmonary functions were checked before and after the treatment. RESULTS: After the treatment, the number of emergency visiting for asthma attack in SIT group was significantly less than that in ICS group. The serum levels of IL-4 and IL-13 were clearly reduced, IFN-gamma and the ratio of IFN-gamma/IL-4 were significantly increased, the pulmonary functions (forced vital capacity (FVC), forced expiratory volume in one second percentage (FEV(1)%) and peak expiratory flow percentage (PEF%) were significantly improved in the SIT group. Meanwhile, IFN-gamma and the ratio of IFN-gamma/IL-4 were greatly increased, but serum levels of IL-4 and IL-13 had less changes, the pulmonary functions (FVC, FEV(1)% and PEF%) were poorly improved in ICS group. The basic pulmonary functions in both groups were at the same level, which had made more improvement in SIT group than in ICS group one year later. CONCLUSIONS: One year of dermatophagoides pteronyssinus SIT can significantly reduce the frequencies of emergency visiting for asthma attack and improve the pulmonary functions of children with allergic asthma, and that is attributed to SIT, which can reduce the levels of IL-4 and IL-13 and regulate the imbalance of the Th1/Th2 cells in asthmatic children. All of these might be effective in preventing the asthmatic airway from remodeling.

15. Cohon A. Assessment of BCG as an adjuvant in specific immunotherapy in asthmatic patients [Dissertation] [Avaliação do BCG como adjuvante na imunoterapia específica para asmáticos]. LILACS 397931. Universidade De São Paulo. Departamento De Clínica Médica 2004;100p.
Keywords: AIRWAYS ID: AST/ asthma; BCG vaccine;
Abstract: Decreased exposure to infectious agents has been pointed as one of the factors involved in the increasing of allergic diseases. Immune dysfunction underlines atopy. Cytokines profile during antigen presentation is decisive to define immune response. Association of BCG vaccine with specific immunotherapy for Dermatophagoides pteronyssinus were assessed in double blind randomized study in 21 asthmatic patients. Improvement in clinical symptoms and in pulmonary function, reduction in cutaneous reactivity and in lymphoproliferation with Dpt extract and increase in specific IgG and IL-10 levels, were observed in both groups, with or without BCG. No difference were observed between groups.

16. D'Anneo RW, Arena A, Gammeri E, Bruno ME , Falagiani P, Riva G, Leonardi S, La Rosa M. Parietaria sublingual allergoid immunotherapy with a co-seasonal treatment schedule. 2008298427. Allergologia Et Immunopathologia 2008;36(2):79-84.
Keywords: AIRWAYS ID: AST/ Adult; Article; Aspergillus; *Asthma/ Dt [Drug Therapy]; Controlled Study; Dermatophagoides; Drug Safety; Female; Human; Immunotherapy; Major Clinical Study; Male; Parietaria; *Rhinitis/ Dt [Drug Therapy]; Skin Test; Visual Analog Scale; *Allergoid/ Cm [Drug Comparison]; *Allergoid/ Dt [Drug Therapy]; *Allergoid / Li [Sublingual Drug Administration]; Antihistaminic Agent/ Cm [Drug Comparison]; Antihistaminic Agent/ Dt [Drug Therapy]; Bronchodilating Agent/ Cm [Drug Comparison]; Bronchodilating Agent/ Dt [Drug Therapy]; *Immunomodulating Agent/ Cm [Drug Comparison]; *Immunomodulating Agent/ Dt [Drug Therapy]; *Immunomodulating Agent/ Li [Sublingual Drug Administration]; Methacholine
Abstract: Background: Sublingual immunotherapy (SLIT) with monomeric allergoid, given according to the standard scheme, resulted effective and safe. However, the achievement of a clinical benefit requires a long time. We thus performed this study using an administration protocol starting in the co-seasonal period with a 3-day build-up phase and lasting only 6 months, in order to obtain the above benefit in a shorter time. Methods and results: The study, prospective, randomised and controlled versus drug therapy, was conducted on 65 rhinitic and/or asthmatic patients allergic to Parietaria with or without other sensitisations. Twenty-four were allocated to 1,000 AU/week, 21 to 3,000 AU/week and 21 to drug therapy. They were treated from April to September 2006. At baseline, 3 and 6 months a Visual Analogue Scale (VAS) was performed to assess the patients' well-being. Drug consumption was evaluated by means of monthly diary cards. Bronchial reactivity was investigated at baseline and 6 months by methacholine challenge test. There was a greater VAS improvement in both the SLIT groups than in the controls after 6 months (p < 0.05). In patients taking 3,000 AU/week this was already evident after 3 months. There was a significant reduction in rescue medication consumption between 3 and 6 months (p < 0.05) in all three groups. The bronchial reactivity was reduced only in the SLIT groups (p < 0.001). No adverse events were observed. Conclusions: At 6 months the allergoid SLIT showed itself to be effective and safe. In addition the subjective clinical benefit was obtained in a more rapid period, i.e. 3 instead of 6 months, when a higher maintenance dose was administered.

17. de Bot CM, Moed H, Berger MY, Roder E, de Groot H, de Jongste JC, Gerth van Wijk R, and van der Wouden JC. Randomized double-blind placebo-controlled trial of sublingual immunotherapy in children with house dust mite allergy in primary care: study design and recruitment. CN-00652569. BMC Family Practice 2008;9(1):59.
Abstract: ABSTRACT: BACKGROUND: For respiratory allergic disorders in children, sublingual immunotherapy has been developed as an alternative to subcutaneous immunotherapy. Sublingual immunotherapy is more convenient, has a good safety profile and might be an attractive option for use in primary care. A randomized double-blind placebo-controlled study was designed to establish the efficacy of sublingual immunotherapy with house dust mite allergen compared to placebo treatment in 6 to18-year-old children with allergic rhinitis and a proven house dust mite allergy in primary care. Described here are the methodology, recruitment phases, and main characteristics of the recruited children. METHODS: Recruitment took place in September to December of 2005 and 2006. General practitioners (in south-west Netherlands) selected children who had ever been diagnosed with allergic rhinitis. Children and parents could respond to a postal invitation. Children who responded positively were screened by telephone using a nasal symptom score. After this screening, an inclusion visit took place during which a blood sample was taken for the RAST test. RESULTS: A total of 226 general practitioners invited almost 6000 children: of these, 51% was male and 40% <12 years of age. The target sample size was 256 children; 251 patients were finally included. The most frequent reasons given for not participating were: absence or mildness of symptoms, absence of house dust mite allergy, and being allergic to grass pollen or tree pollen only.
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