Safety of long-acting beta-agonists.
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Adrenal Cortex Hormones↗
Biomedical subjects
Harold S Nelson
Publications and source records attributed to Harold S Nelson.
Long-acting beta-agonists in adult asthma: Evidence that these drugs are safe.
If asthma is not controlled with low-dose inhaled corticosteroids (ICS), by far the best next step is the addition of a long-acting, inhaled beta-agonist (LABA). Questions regarding the safety of this class of drug have been raised. However, careful examination of the reports which have caused concern in this regard does not reveal any evidence of an increased risk associated with the appropriate use (i.e. in combination with an inhaled ICS) of LABAs in asthma. There is much to suggest that the adverse outcomes associated with LABA monotherapy have been due to "masking of inflammation" rather than a toxic effect of the drugs. In some instances, this has likely allowed worsening asthma to be overlooked - with dire consequences. Studies in subjects receiving combination therapy with LABAs plus ICSs suggest that, if anything, there is an enhanced anti-inflammatory action with the LABA/ICS combination superior to that achieved with ICS alone at the same dose.
Administration, Inhalation↗
Advances in upper airway diseases and allergen immunotherapy.
The purpose of this review is to highlight important articles on upper airway disease and immunotherapy that appeared in the Journal of Allergy and Clinical Immunology and elsewhere during 2005. In recent studies of tissue from patients with chronic hypertrophic eosinophilic sinusitis, increased leukotriene C4 synthase and 5-lipoxygenase activity and increased levels of cysteinyl leukotriene production were demonstrated that correlated with disease severity but not with whether the patient was aspirin sensitive. However, the cysteinyl leukotriene 1 receptor was increased in leukocytes in the sinus tissue only in those patients with aspirin sensitivity. Major basic protein, released by eosinophils into the mucus in the paranasal sinus lumen, was found to reach concentrations capable of damaging the sinus epithelium, predisposing to bacterial infections. Testing the hypothesis that chronic hypertrophic eosinophilic sinusitis represents a reaction to common fungi, a double-blind trial of intranasal instillation of amphotericin B was conducted. There were marginal but significant differences in favor of amphotericin B treatment for sinus mucosal thickening on the basis of computed tomography and the evidence of eosinophilic inflammation in the sinus mucus. The effectiveness of topical nasal corticosteroids for treatment of nasal polyps was confirmed in 2 large studies. Improvement in sleep quality and daytime drowsiness in patients with allergic rhinitis treated with nasal corticosteroids was reported to correlate with reduction in nasal obstruction. The statistical analysis behind studies that reported a decrease in asthma exacerbations with nasal corticosteroids or oral antihistamines has been questioned. It appears that the results of at least one of these studies are indeed too good to be true. Although caution is still indicated in administering immunotherapy to patients receiving beta-adrenergic blocking agents, the prohibition might not be absolute. A study in patients with Hymenoptera sensitivity given venom immunotherapy revealed no increase in serious adverse reactions to venom injections and no greater incidence of reactions to insect stings in those taking beta-blocking agents. Sublingual immunotherapy for 8 to 12 weeks in patients with hazelnut sensitivity significantly increased their tolerance to hazelnut in double-blind, placebo-controlled challenges while inducing increased IgG4 and IL-10 levels, indicating induction of regulatory T cells. There were a number of articles in the Journal of Allergy and Clinical Immunology in 2005 that addressed the entity of chronic hypertrophic eosinophilic sinusitis. In addition, an update of the "Practice parameters on sinusitis" was published. The major focus in allergen immunotherapy continues to be sublingual administration.
Allergens↗
Is there a problem with inhaled long-acting beta-adrenergic agonists?
Short-acting beta(2)-agonists are effective in relieving acute symptoms of asthma and in the short-term prevention of symptoms from stimuli, such as exercise. They are ineffective when used on a regular schedule to improve asthma control. Long-acting beta(2)-agonists, on the other hand, provide sustained bronchodilation and improve asthma control. Regular use of long-acting beta(2)-agonists is not associated with significant tolerance to their bronchodilator action, impairment in the response to albuterol, decreased baseline pulmonary function, increased response to methacholine, or increased risk of adverse cardiac events. Case-control studies do not suggest an increased risk for death or intensive care unit admissions with use of long-acting beta(2)-agonists. In prospective studies in which there has been an increase in asthma deaths or serious asthma exacerbations, this increased risk has not been observed in subjects using inhaled corticosteroids. Where increased deaths have occurred in relation to either short- or long-acting beta(2)-agonists, the events have not occurred equally throughout the exposed population. This suggests that these outcomes were not a direct toxic effect of the drugs and increases the possibility that they resulted from an interaction between relief of symptoms by beta(2)-agonists and delay in seeking medical care.
Administration, Inhalation↗
Sublingual immunotherapy: a comprehensive review.
Sublingual immunotherapy (SLIT) has been used with increasing frequency in Europe and is viewed with increasing interest by allergists in the United States. To address this interest, a Joint Task Force of the American College of Allergy, Asthma and Immunology and the American Academy of Allergy, Asthma and Immunology's Immunotherapy and Allergy Diagnostic Committees reviewed the available literature on SLIT and prepared this report. The task force concluded that despite clear evidence that SLIT is an effective treatment, many questions remained unanswered, including effective dose, treatment schedules, and overall duration of treatment. Until these have been determined, an assessment of the cost/benefit ratio of the treatment cannot be made. SLIT does appear to be associated with few serious side effects, but it has not been administered in high-risk asthmatic patients, nor in the studies reviewed has it been administered as a mixture of non-cross-reacting allergens. Furthermore, there is currently no allergy extract approved for this use in the United States, nor is there a Current Procedural Terminology code for billing purposes. All of these factors should be given careful consideration by anyone contemplating initiating SLIT treatment for their allergic patients.
Administration, Sublingual↗
Immunologic response to administration of standardized dog allergen extract at differing doses.
BACKGROUND: The immunologic response to immunotherapy with dog extract is not well characterized. OBJECTIVE: The purpose of this study was to examine the immunologic response to 3 doses of dog extract expressed as their Can f 1 content. METHODS: Cluster immunotherapy was administered to 28 patients with dog allergy who were randomly assigned to 1 of 4 treatment arms: placebo or acetone-precipitated extract containing 0.6 mug, 3.0 mug, or 15.0 mug Can f 1 per 0.5 mL maintenance dose. Studies included titrated skin prick tests, the late cutaneous response, titrated nasal challenge with dog extract, and serum allergen-specific IgE and IgG(4). Dog allergen-stimulated lymphocyte proliferation was performed with measurement of secreted cytokines by ELISA and of intracellular cytokines by flow cytometry. RESULTS: There was a significant dose-dependent response in suppression of titrated skin prick tests and suppression of the late cutaneous response. There was a significant increase from baseline in dog-specific IgG(4) in both the high-dose and low-dose groups and a dose-dependent suppression of secreted TNF-alpha and increase in secreted TGF-beta. There was a dose-dependent trend in suppression of secreted IL-4 with a significant decrease from baseline in the high-dose group. There were no significant changes in symptom scores; lymphocyte proliferation; secreted IFN-gamma, IL-10, or IL-5; or intracellular cytokine production. CONCLUSION: The dose-response in immunologic parameters after immunotherapy with dog extract is similar to that previously demonstrated with cat extract. CLINICAL IMPLICATIONS: The greatest and most consistent response is seen with a dose containing 15 mug Can f 1.
Allergens↗
Efficacy and safety of allergen immunotherapy in children.
OBJECTIVE: To determine the efficacy and safety of immunotherapy in children with allergic rhinitis and allergic asthma. DATA SOURCES: Current Contents database for 1967 to 2005. STUDY SELECTION: The expert opinion of the author was used to select studies for inclusion in this review. RESULTS: Meta-analyses have confirmed the clinical effectiveness of allergen immunotherapy in patients with allergic rhinitis and asthma; however, most studies involved immunotherapy with a single allergen. Special considerations of safety regarding immunotherapy in children are also necessary, since fatalities have been reported. Fatal reactions occur primarily in patients with asthma and particularly those whose asthma is not well controlled. There is probably increased risk during the build-up phase and with the first injection from a new vial. Injections at home or in clinics without adequate supervision also constitute an increased risk of a fatal outcome. CONCLUSIONS: Specific immunotherapy has been demonstrated to have some protective effect against the development of additional sensitivities in the monosensitized child and to reduce the risk of developing asthma in children with allergic rhinitis. Because of the modification of the underlying immune process, the beneficial effects of immunotherapy persist for a long but not yet fully determined period after the cessation of treatment. This persisting effect makes immunotherapy an attractive supplement to symptomatic treatment of children with allergic asthma and allergic rhinitis. The treatment is not without risk, however, especially in the child with asthma, so it should be administered with caution.
Age Factors↗
Skin testing.
OBJECTIVE: To provide the reader with a relevant review of the literature regarding skin testing in the allergist's office. DATA SOURCES: A PubMed search for the years 1970 through 2005 was performed using the following keywords: allergy skin testing, skin prick testing, and intradermal skin testing. STUDY SELECTION: Articles that highlighted aspects of sentinel to clinical allergists' use of skin testing in the office, such as methods of skin testing, intradermal vs skin prick testing, skin test devices, and methods of expressing skin test results, were selected for further review. RESULTS: Skin testing remains the central test to confirm an allergic response. It is minimally invasive and when performed correctly has good reproducibility. Results are easily quantifiable and correlate well with end organ challenge. It is imperative however that technicians who perform the skin tests and the clinicians who order or interpret these tests understand the characteristics of the specific tests they are administering. It is also important that the clinician express skin test results in a manner that allows easy interpretation by another physician. CONCLUSIONS: Allergists must consider controllable variables that affect skin test results and their interpretation. When not considered, they may be responsible for some of the inaccuracies associated with allergy skin testing.
Humans↗
Skin testing: a survey of allergists.
BACKGROUND: In the allergist's office, skin testing remains the central way to confirm allergic response. Although anecdotal data suggest widely varying practices in skin testing by allergists, the diversity and relative frequency of these practices have not been documented. OBJECTIVE: To determine the extent of the diversity in skin testing practices among allergists. METHODS: A questionnaire was sent via the Internet to all physician members and fellows of the American College of Allergy, Asthma and Immunology who practice in the United States. This survey explored choice of extract concentrations, skin test device, number and type of tests, method for interpretation and documentation of skin test results, and quality assurance procedures used. RESULTS: Overall, a significant degree of variability was reported with regard to number of skin tests performed, extract concentrations, skin test devices, interpretation and documentation of results, and quality assurance procedures. The average number of skin prick tests performed ranged from 5.09 (grasses) to 10.9 (trees), whereas the average number of intradermal tests performed ranged from 2.03 (grasses) to 5.6 (perennial). The allergen extract concentrations used for intradermal testing varied widely. Expressed as a dilution of the concentrated extracts, 20.8% use 1:100 dilutions, 10.3% use 1:500 dilutions, and 59.4% use 1:1,000 dilutions. Significant variability also occurred regarding devices and the technique with which the devices were used. Most clinicians (92.1%) used the most concentrated extract available for skin prick testing. For reporting the results of skin testing, 53.8% used a 0 to 4+ scale, and only 28.3% measured orthogonal diameters. Of those using a 0 to 4+ scale, two thirds related the results to the size of the histamine control. Quality assurance testing was reportedly performed by 61.2% of responders. However, less than 10% of responders used an objective test protocol for this purpose. CONCLUSIONS: This survey highlights some of the areas that allergists can improve on in the use and reporting of skin tests.
Allergy and Immunology↗
The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol.
STUDY OBJECTIVE: To compare the safety of salmeterol xinafoate or placebo added to usual asthma care. DESIGN: A 28-week, randomized, double-blind, placebo-controlled, observational study. SETTING: Study subjects were seen once in the study physician's office for screening and were provided all blinded study medication for the entire study period. Follow-up by telephone was scheduled every 4 weeks. PARTICIPANTS: Subjects (> 12 years old) with asthma as judged by the study physician were eligible. Individuals with a history of long-acting beta2-agonist use were excluded. INTERVENTIONS: Salmeterol, 42 mug bid via metered-dose inhaler (MDI), and placebo bid via MDI. MEASUREMENTS AND RESULTS: Following an interim analysis in 26,355 subjects, the study was terminated due to findings in African Americans and difficulties in enrollment. The occurrence of the primary outcome, respiratory-related deaths, or life-threatening experiences was low and not significantly different for salmeterol vs placebo (50 vs 36; relative risk [RR] = 1.40; 95% confidence interval [CI], 0.91 to 2.14). There was a small, significant increase in respiratory-related deaths (24 vs 11; RR, 2.16; 95% CI, 1.06 to 4.41) and asthma-related deaths (13 vs 3; RR, 4.37; 95% CI, 1.25 to 15.34), and in combined asthma-related deaths or life-threatening experiences (37 vs 22; RR, 1.71; 95% CI, 1.01 to 2.89) in subjects receiving salmeterol vs placebo. The imbalance occurred largely in the African-American subpopulation: respiratory-related deaths or life-threatening experiences (20 vs 5; RR, 4.10; 95% CI, 1.54 to 10.90) and combined asthma-related deaths or life-threatening experiences (19 vs 4; RR, 4.92; 95% CI, 1.68 to 14.45) in subjects receiving salmeterol vs placebo. CONCLUSIONS: For the primary end point in the total population, there were no significant differences between treatments. There were small, but statistically significant increases in respiratory-related and asthma-related deaths and combined asthma-related deaths or life-threatening experiences in the total population receiving salmeterol. Subgroup analyses suggest the risk may be greater in African Americans compared with Caucasian subjects. Whether this risk is due to factors including but not limited to a physiologic treatment effect, genetic factors, or patient behaviors leading to poor outcomes remains unknown.
Administration, Inhalation↗
Effects of esomeprazole 40 mg twice daily on asthma: a randomized placebo-controlled trial.
RATIONALE: Gastroesophageal reflux disease (GERD) is common in patients with asthma, suggesting an interaction between the two conditions. OBJECTIVES: To assess the effect of gastric acid suppression with the proton pump inhibitor esomeprazole on asthma outcomes in subjects with persistent moderate to severe asthma treated with antiinflammatory asthma medication. METHODS: In this double-blind study, subjects were randomized to receive esomeprazole 40 mg or placebo twice daily for 16 wk. According to nocturnal respiratory symptoms (NOC) and GERD, subjects were divided into three strata: GERD-/NOC+, GERD+/NOC-, and GERD+/NOC+. MEASUREMENTS AND MAIN RESULTS: A total of 770 subjects were randomized. There was no statistically significant improvement in morning peak expiratory flow (PEF) over placebo in the overall study population: 6.3 L/min (p = 0.061). Over the whole treatment period, in GERD+/NOC+ subjects (n = 350), esomeprazole provided an 8.7-L/min improvement (p = 0.03) in morning PEF, and a 10.2-L/min improvement (p = 0.012) in evening PEF over placebo. Among 307 subjects taking long-acting beta2-agonists, improvements over placebo were observed in morning PEF (12.2 L/min, p = 0.017) and in evening PEF (11.1 L/min, p = 0.024); these improvements were more pronounced in GERD+/NOC+ subjects. Esomeprazole 40 mg twice daily was well tolerated and no safety concerns were noted. CONCLUSIONS: Esomeprazole improved PEF in subjects with asthma who presented with both GERD and NOC. In subjects without both GERD and NOC, no improvement could be detected.
Administration, Oral↗
Combination therapy of long-acting beta agonists and inhaled corticosteroids in the management of chronic asthma.
Both the Global Initiative for Asthma (GINA) and the National Heart, Lung and Blood Institute (NHLBI) Expert Panel guidelines recommend combination treatment with inhaled corticosteroids (ICSs) and inhaled long-acting beta-agonists (LABAs) for patients whose asthma is not adequately controlled by low doses of ICSs alone. Not only is this combination more effective than the combination of either theophylline or leukotriene modifiers with ICSs, there is suggestive evidence that the results with LABAs and ICSs may be more than additive. Through the effect of each one on the receptor for the other, they may have a synergistic action. This marked effectiveness of the combination, particularly when combined in the same device, has led to new objectives and novel applications. Therefore, for the first time, it appears that the Goals of Asthma Therapy, as outlined in the guidelines, are achievable for many patients with asthma. Also, at least for combination therapies including formoterol, adjustable dosing and perhaps even use as a rescue as well as a maintenance therapy may be possible.
Administration, Inhalation↗
Advances in upper airway diseases and allergen immunotherapy.
Evidence of an increased prevalence of rhinitis in patients with asthma, and asthma in patients with rhinitis, supports the 1 airway concept. However, there are basic differences between the upper and lower airways, such as the virtual absence of remodeling in the nose compared with the bronchi, despite the presence of similar inflammation. Etiologic factors in chronic rhinosinusitis (CRS) attract increasing interest. Peripheral blood monocytes from patients with CRS release IL-4, IL-13, and IFN-gamma on stimulation with fungal antigens, especially those from Alternaria. This is not seen with cells from normal controls. However, a double-blind trial of intranasal amphotericin in CRS was negative. Evidence continues to accumulate of the pivotal role of regulatory T-lymphocytes secretion of IL-10 in the response to allergen immunotherapy. In patients with asthma and house dust mite allergy who are receiving appropriate pharmacotherapy and have instituted environmental controls, house dust mite immunotherapy provides marginal additional benefits in asthma control. Immunotherapy with cat dander extract at a maintenance dose containing 15 microg Fel d 1 produces a more consistent immunologic response than with maintenance doses containing 3.0 microg, whereas doses containing only 0.6 microg are no more effective than placebo. Sublingual immunotherapy for seasonal grass allergy can be safely administered by general practitioners, but symptom relief begins only in the second season of therapy. Sublingual immunotherapy for seasonal grass allergy in children reduced symptoms and onset of new asthma symptoms but, again, beginning only in the second year of treatment. A course of 6 weekly injections of ragweed Amb a 1 bound to cytosine phosphorothionate guanosine containing DNA produced a shift from T H 2 to T H 1 cytokine release both in peripheral blood cells and in the nose after allergen challenge. No symptom improvement was seen the first year, but symptoms were reduced the second year without further treatment.
Allergens↗
Hydrofluoroalkane-134A beclomethasone or chlorofluorocarbon fluticasone: effect on small airways in poorly controlled asthma.
Inflammation in asthma extends into the small airways (< 2 mm diameter). Most inhaled corticosteroids are suspensions with a particle size > 2 mm. Therefore, inflammation in the small airways of patients with asthma may not be adequately treated with these preparations. Some inhaled corticosteroids, on the other hand, are compounded with alcohol, resulting in a solution producing an aerosol that has a mean particle diameter of < 2 mm. This study was designed to compare the addition of equivalent amounts of two inhaled corticosteroids (one a suspension and one a solution) to the treatment of patients with asthma, which was uncontrolled despite treatment with moderate to high doses of inhaled corticosteroids and usually additional controller medications. The study was performed with 30 patients, > or = 18 years of age. Subjects were randomized in a single-blind fashion to receive, in addition to their current asthma therapy, either CFC-FP 220 microg each morning and 110 microg each evening (n = 10) or HFA-BDP 160 mcg twice daily (n = 20). Pre- and postbronchodilator spirometry, single breath nitrogen washout for closing volume and residual volume by plethysmography were assessed before and after 3 months of therapy. In the subjects who received HFA-BDP, the ratio of closing volume (CV) to vital capacity (VC) and residual volume (RV) decreased significantly (p = 0.0214 and 0.0433, respectively), whereas forced expiratory flow over 25-75% of the vital capacity (FEF25-75%), forced expiratory volume in 1 second (FEV1), and morning peak flow improved significantly (p = 0.0014, 0.0184, and 0.0321). Improvements from baseline of CV, CV/VC, and postbronchodilator FEF25-75%, were statistically significant in the HFA-BDP group compared with the CFC-FP group (p = 0.0049, 0.0194, and 0.0355, respectively). These preliminary findings suggest that the addition of HFA-BDP, compared with CFC-FP in patients with poorly controlled asthma despite receiving moderate to high doses of inhaled steroids, has a greater effect on parameters reflecting small airway patency presumably secondary to reduction in inflammation.
Administration, Inhalation↗
Fluticasone propionate nasal spray is superior to montelukast for allergic rhinitis while neither affects overall asthma control.
BACKGROUND: Asthma and allergic rhinitis are both highly prevalent diseases and often coexist in patients. OBJECTIVE: To investigate the effect of rhinitis therapy on asthma outcomes in adult and adolescent patients with both seasonal allergic rhinitis (SAR) and persistent asthma. METHODS: A total of 863 patients (mean baseline FEV1 81% predicted) were randomized to receive open-label fluticasone propionate/salmeterol (FSC), 100/50 microg bid for 4 weeks, plus either blinded fluticasone propionate aqueous nasal spray (FPANS) 200 microg/d, montelukast 10 mg/d, or placebo. Patients kept daily records of peak expiratory flow (PEF), asthma, and rhinitis symptoms and rescue albuterol use. RESULTS: FPANS added to FSC resulted in superior outcomes for daytime total nasal symptom scores (D-TNSS) and individual daytime nasal specific symptoms (congestion, rhinorrhea, sneezing, and itching) compared with montelukast plus FSC and placebo plus FSC (p < or = 0.001). Montelukast plus FSC was superior to placebo plus FSC only for D-TNSS and itching and sneezing. Morning PEF, asthma symptoms, and rescue albuterol use improved significantly (p < or = 0.001) in all treatment groups, but improvements were comparable across the treatment groups. CONCLUSION: In patients with persistent asthma treated with FSC, the addition of montelukast or FPANS for the treatment of SAR resulted in no additional improvements in overall asthma control compared with FSC alone. However, FPANS provided superior rhinitis control compared with montelukast. These data suggest that asthma and rhinitis should each be optimally treated.
Acetates↗
A comparison of multiheaded devices for allergy skin testing.
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Adolescent↗
Advances in upper airway diseases and allergen immunotherapy.
Evidence for one airway continues to accumulate. Nasal allergen challenges increase lower airway inflammation, and nasal corticosteroid treatment reduces lower airway inflammation. Allergic respiratory inflammation might even spread systemically to involve nonrespiratory organs. Eosinophilic enteritis and eosinophilic esophagitis are reported during pollen seasons in patients with seasonal allergic rhinitis. Chronic hypertrophic sinusitis (CHS) is found in the majority of patients with asthma. Like asthma, the histology of CHS is characterized by epithelial damage, basement membrane thickening, and eosinophilic inflammation. The damaged epithelium might explain the acute bacterial exacerbations seen in patients with CHS. Studies have extended evidence of the safety and efficacy of the second- and third-generation antihistamines to younger children and to patients with perennial rhinitis but continue to show improvement of symptom scores over that seen with placebo of less than 20%. Studies on antihistamine use in the first trimester in nearly 500 women (65% taking loratadine) revealed no increase in the complications of pregnancy or congenital anomalies. Positive skin prick test responses to birch in asymptomatic young adults predicted later development of clinical allergic rhinitis. A dose response was demonstrated for immunotherapy with cat dander extract. The best results were in subjects receiving a dose containing 15 microg of the major cat allergen Fel d 1 (equivalent to approximately 2500 bioequivalent allergen units). Both topical intranasal immunotherapy and high-dose sublingual immunotherapy have been repeatedly proved to be safe and effective in double-blind, placebo-controlled studies. CD4+CD25+ regulatory T cells secreting IL-10, TGF-beta, or both appear important in normal individuals and in patients treated with allergen immunotherapy in maintaining or restoring normal T(H)1/T(H)2 balance and overall suppression of both phenotypes.
Allergens↗
Dose dependence and time course of the immunologic response to administration of standardized cat allergen extract.
BACKGROUND: The immunologic response to allergen immunotherapy with 3 serial 5-fold doses of cat extract has been studied after approximately 5 weeks of immunotherapy. The highest dose containing 15 mug of Fel d 1 produced the most consistent and favorable response. It is unknown whether the comparative response on reaching a maintenance dose is maintained with long-term maintenance therapy. OBJECTIVE: The purpose of this investigation was to evaluate the immunologic responses with these 3 serial doses of cat hair and dander extract at baseline, after reaching the maintenance dose (approximately 5 weeks), and after 1 year of maintenance immunotherapy. METHODS: Twenty-eight patients with cat allergy randomized in a double-blind study were assigned to one of 4 treatment groups: placebo or cat hair and dander extract containing 0.6 mug of Fel d 1, 3 mug of Fel d 1, and 15 mug of Fel d 1 at maintenance. Studies included skin prick tests and late cutaneous reactions with cat hair and dander extract, titrated nasal challenges with the extract, serum cat allergen-specific IgG4 and IgE measurement, and flow cytometric and ELISA analysis of whole blood and intranasal cytokines (TGF-beta, IL-10, IFN-gamma, IL-4, and IL-5). RESULTS: Twenty-six subjects completed the study. After both 5 weeks and 1 year, significant and dose-dependent differences were seen with total symptom scores on nasal challenge ( P < .0001), with titrated skin prick testing with cat dander extract at 5 weeks ( P = .014) and 1 year ( P < .0001), and with cat-specific IgG4 measurement at 5 weeks ( P = .004) and 1 year ( P = .003). At 1 year, neither flow cytometry of whole blood nor ELISA evaluation of nasal cytokines demonstrated any significant differences among the treatment groups. CONCLUSION: The response to titrated nasal allergen challenge, titrated skin prick testing, and allergen-specific IgG4 measurement to cat immunotherapy at 5 weeks is predictive of the response at 1 year.
Allergens↗