Clinical trial design, nasal allergen challenge models, and considerations of relevance to pediatrics, nasal polyposis, and different classes of medication

Åkerlund, Anders; Andersson, Morgan; Leflein, Jeffrey; Lildholdt, Torben; Mygind, Niels

doi:10.1016/j.jaci.2004.12.016

Cited by 71 publications

(63 citation statements)

References 192 publications

(227 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…When the symptom score reached or exceeded 5 or reached 4 with a decrease in nasal flow of 40% according to the basal value, the test was regarded as positive. NPT was discontinued when there was a positive reaction or the maximum allergen concentration was reached [24]. …”

Section: Methodsmentioning

confidence: 99%

Desensitization Effect of Preseasonal Seven-Injection Allergoid Immunotherapy with Olive Pollen on Basophil Activation: The Efficacy of Olive Pollen-Specific Preseasonal Allergoid Immunotherapy on Basophils

Gökmen¹,

Ersoy²,

Gülbahar³

et al. 2012

Int Arch Allergy Immunol

View full text Add to dashboard Cite

Background: It has previously been demonstrated that subcutaneous immunotherapy with allergoids positively affects clinical and immunological parameters even after 7 preseasonal injections. However, its effect on basophil activation remains unclear. We investigated the effect of preseasonal allergoid immunotherapy on basophils and concomitantly assessed its clinical and immunological efficacy in olive pollen-monosensitized patients. Methods: This study enrolled 437 consecutive patients with respiratory allergy and positive skin prick tests (SPTs); 212 (48.5%) patients were sensitized to olive pollen, and 33 (7.5%) patients were sensitized to olive pollen only. Of these patients, 23 received preseasonal immunotherapy with an olive pollen allergoid. The olive pollen-specific basophil activation, the titrated nasal provocation test, the nasal symptom score, and olive pollen-specific IgE, IgG1 and IgG4 levels were evaluated before immunotherapy and 8 months after the end of immunotherapy in the follow-up visit. Results: In comparison to baseline evaluation, 7 preseasonal injections of an allergoid resulted in a significant decrease in the percentage of basophils expressing CD63 (29 vs. 7%, respectively, p < 0.0001) and a significant increase in the titrated nasal provocative dose (1/10 vs. 1/1, respectively, p < 0.01). SPT induration diameters caused by an olive pollen extract decreased (12 mm at baseline vs. 5.5 mm at follow-up, p < 0.005), as did nasal symptom score (7 at baseline vs. 3 at follow-up, p < 0.01). Olive pollen-specific IgE (17.5 vs. 50 kU/l, p < 0.012), IgG1 (0.16 vs. 2.9 µg/ml, p < 0.0001) and IgG4 (0.07 vs. 1.92 µg/ml, p < 0.0001) levels significantly increased. Conclusions: Immunotherapy with 7 preseasonal injections of an olive pollen allergoid decreases olive pollen-specific basophil activation over 8 months, an effect observed in vitro and in vivo.

show abstract

Section: Methodsmentioning

confidence: 99%

Desensitization Effect of Preseasonal Seven-Injection Allergoid Immunotherapy with Olive Pollen on Basophil Activation: The Efficacy of Olive Pollen-Specific Preseasonal Allergoid Immunotherapy on Basophils

Gökmen¹,

Ersoy²,

Gülbahar³

et al. 2012

Int Arch Allergy Immunol

View full text Add to dashboard Cite

show abstract

“…Logistical problems are presented by traditional studies that are scheduled to coincide with peak pollen season, as levels can be influenced by weather, highly variable between sites and consecutive seasons, significantly impacting the apparent efficacy of treatment [21]. Furthermore, individual participants' exposures are affected by lifestyle [22], adherence to scheduled administration of study medication, and symptom recording cannot always be ensured [6,23]. CACFs were developed to address these variables, while recapitulating many characteristics of an outdoor allergy study [2••, 6, 23].…”

Section: Advantages Of the Cacf Modelmentioning

confidence: 99%

Controlled Allergen Challenge Facilities and Their Unique Contributions to Allergic Rhinitis Research

North

Soliman

Walker

et al. 2015

Curr Allergy Asthma Rep

View full text Add to dashboard Cite

The aim of this study is to review advances in basic and clinical allergic rhinitis (AR) research over the past decade that have been conducted using controlled allergen challenge facility (CACF) models of allergen challenge. Databases, including PubMed, Medline, and Web of Science were searched for articles employing an ambient pollen exposure in a controlled facility to study AR, published between 2004 and the present date, using the terms as follows: CACF, Environmental Exposure Unit (EEU), Vienna Challenge Chamber (VCC), Fraunhofer Institute Environmental Challenge Chamber, Atlanta Allergen Exposure Unit, Biogenics Research Chamber, Allergen BioCube, Chiba and Osaka Environmental Challenge Chamber, exposure unit, challenge chamber, or environmental exposure chamber. Articles were then selected for relevance to the goals of the present review, including important contributions toward clinical and/or basic science allergy research. CACFs offer sensitive, specific, and reproducible methodology for allergen challenge. They have been employed since the 1980s and offer distinct advantages over traditional in-season multicentre trials when evaluating new treatments for AR. They have provided clinically applicable efficacy and pharmacologic information about important allergy medications, including antihistamines, decongestants, antileukotrienes, immunotherapies, and nasal steroids. CACF models have also contributed to basic science and novel/experimental therapy research. To date, no direct studies have been conducted comparing outcomes from one CACF to another. Over the past decade, CACF models have played an essential role in investigating the pathophysiology of AR and evaluating new therapies. The future opportunities for this model continue to expand.

show abstract

“…Drug provocation tests provide definite diagnosis wherein drugs are given either as oral challenge tests, as per full dose prescribed by the physician or organ challenge to clarify the role of allergens associated with specific organs. 13,14 The European Network on drug Allergy (ENDA) and European Academy of Allergy and Clinical Immunology (EAACI) Interest Group on Drug Allergy have published guidelines and position papers on techniques, procedures, diagnostic approach to skin testing, drug provocation tests as well as recommendations for the management of β lactam hypersensitivity. 15 They have proposed the use of Non irritating Concentrations (NIC) and a step wise diagnostic protocol to approach antimicrobial immediate hypersensitivity reactions, which have been validated via trials on their population.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of immediate reactions to β lactam antibiotics using a comprehensive diagnostic protocol

Bhagwat

Anuradha

2017

Int J Basic Clin Pharmacol

View full text Add to dashboard Cite

Background: β lactam antibiotics are commonly prescribed groups of antibacterial drugs for various infections however the prevalence of its allergic effects is not clear in our country, hence the need for an effective diagnostic protocol to determine immediate hypersensitivity reactions. The objective was to formulate a diagnostic protocol for evaluating immediate drug hypersensitivity to β lactam antibiotics.Methods: A prospective study was conducted at a tertiary care hospital. Adults who were prescribed any class of β lactam antibiotic were included. Non irritating concentrations of the antibiotic as per The European Network on drug Allergy were used. A strict three step diagnostic algorithm with skin prick test followed by intradermal test and drug provocation test, with 20 minutes observation period between each step, to determine cutaneous allergic reactions was followed.Results: The most commonly prescribed drug was cefazolin, followed by ceftriaxone, and cefoperazone + sulbactam combination. The culprit drugs were ceftriaxone in 4 (4.7%) patients, followed by piperacillin + tazobactam combination in 3 (3.5%), amoxicillin + clavulanic acid in 2 (2.3%) and 1 (1.1%) each for cefotaxime and cefepime + tazobactam combination. No patients were positive for skin prick test; 2.4% were positive for intradermal test and 10.6% were positive for drug provocation test.Conclusions: This diagnostic protocol is apt to adequately diagnose immediate reactions to β lactam antibiotics and henceforth can be used effectively in India. However, the skin prick test may be excluded but the intradermal test and drug provocation test is crucial to identify these immediate reactions.

show abstract

Clinical trial design, nasal allergen challenge models, and considerations of relevance to pediatrics, nasal polyposis, and different classes of medication

Cited by 71 publications

References 192 publications

Desensitization Effect of Preseasonal Seven-Injection Allergoid Immunotherapy with Olive Pollen on Basophil Activation: The Efficacy of Olive Pollen-Specific Preseasonal Allergoid Immunotherapy on Basophils

Desensitization Effect of Preseasonal Seven-Injection Allergoid Immunotherapy with Olive Pollen on Basophil Activation: The Efficacy of Olive Pollen-Specific Preseasonal Allergoid Immunotherapy on Basophils

Controlled Allergen Challenge Facilities and Their Unique Contributions to Allergic Rhinitis Research

Evaluation of immediate reactions to β lactam antibiotics using a comprehensive diagnostic protocol

Contact Info

Product

Resources

About