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Repeatability of nasal allergen challenge results: Further validation of the allergic rhinitis clinical investigator collaborative protocols.
Ann Allergy Asthma Immunol. 2018 06; 120(6):607-613.AA

Abstract

BACKGROUND

Nasal allergen challenge (NAC) models have been used to study allergic rhinitis and new therapies. Symptoms and biological samples can be evaluated at time points after allergen exposure.

OBJECTIVE

To verify protocol repeatability and adequate interval between allergen exposures.

METHODS

Ten ragweed allergic participants were exposed to incrementally increasing dosages of ragweed allergen intranasally until they achieved a total nasal symptom score (TNSS) of 8 of 12 and a peak nasal inspiratory flow (PNIF) of 50% reduction or more from baseline. Three weeks later, participants were challenged with a cumulative dose equal to the sum of all the allergen doses received at screening. TNSS and PNIF were recorded at regular intervals, including a 24-hour assessment. A subsequent visit was conducted after a further 3 weeks. Nasal secretion samples were collected for cytokine and eosinophil quantification.

RESULTS

Nine participants completed all visits. TNSS and PNIF responses followed previous patterns, with an initial peak at 30 minutes followed by a gradual decline. Most participants reported similar patterns at both NAC visits, although some did not demonstrate the same phenotype at both visits. Some experienced a secondary symptom increase 24 hours after NAC. Eosinophil and cytokine sections followed a similar pattern at both NAC visits.

CONCLUSION

NAC is an adequate method for modeling AR in humans, demonstrating appropriate repeatability of symptoms, nasal mucosal eosinophil, and cytokines. The 24-hour time point, previously not studied in our model, may be beneficial in evaluation of long-acting medications. This three-week interval NAC model will be beneficial for studies in which before and after treatment comparisons are desired.

Authors+Show Affiliations

Allergy Research Unit, Kingston General Hospital, Kingston, Ontario, Canada.Allergy Research Unit, Kingston General Hospital, Kingston, Ontario, Canada.Division of Allergy and Immunology, Department of Medicine, Queen's University, Kingston, Ontario, Canada.Allergy Research Unit, Kingston General Hospital, Kingston, Ontario, Canada.Divisions of Clinical Immunology and Allergy and Respirology, Department of Medicine, Firestone Institute of Respiratory Health, The Research Institute at St. Joe's Hamilton and McMaster University, Hamilton, Ontario, Canada.Allergy Research Unit, Kingston General Hospital, Kingston, Ontario, Canada; Division of Allergy and Immunology, Department of Medicine, Queen's University, Kingston, Ontario, Canada. Electronic address: ellisa@queensu.ca.

Pub Type(s)

Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

29432965

Citation

Soliman, Mena, et al. "Repeatability of Nasal Allergen Challenge Results: Further Validation of the Allergic Rhinitis Clinical Investigator Collaborative Protocols." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 120, no. 6, 2018, pp. 607-613.
Soliman M, Steacy LM, Thiele J, et al. Repeatability of nasal allergen challenge results: Further validation of the allergic rhinitis clinical investigator collaborative protocols. Ann Allergy Asthma Immunol. 2018;120(6):607-613.
Soliman, M., Steacy, L. M., Thiele, J., Adams, D. E., Neighbour, H. L., & Ellis, A. K. (2018). Repeatability of nasal allergen challenge results: Further validation of the allergic rhinitis clinical investigator collaborative protocols. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 120(6), 607-613. https://doi.org/10.1016/j.anai.2018.02.009
Soliman M, et al. Repeatability of Nasal Allergen Challenge Results: Further Validation of the Allergic Rhinitis Clinical Investigator Collaborative Protocols. Ann Allergy Asthma Immunol. 2018;120(6):607-613. PubMed PMID: 29432965.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Repeatability of nasal allergen challenge results: Further validation of the allergic rhinitis clinical investigator collaborative protocols. AU - Soliman,Mena, AU - Steacy,Lisa M, AU - Thiele,Jenny, AU - Adams,Dan E, AU - Neighbour,Helen L, AU - Ellis,Anne K, Y1 - 2018/02/09/ PY - 2017/11/02/received PY - 2018/02/05/revised PY - 2018/02/06/accepted PY - 2018/2/13/pubmed PY - 2019/3/8/medline PY - 2018/2/13/entrez SP - 607 EP - 613 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 120 IS - 6 N2 - BACKGROUND: Nasal allergen challenge (NAC) models have been used to study allergic rhinitis and new therapies. Symptoms and biological samples can be evaluated at time points after allergen exposure. OBJECTIVE: To verify protocol repeatability and adequate interval between allergen exposures. METHODS: Ten ragweed allergic participants were exposed to incrementally increasing dosages of ragweed allergen intranasally until they achieved a total nasal symptom score (TNSS) of 8 of 12 and a peak nasal inspiratory flow (PNIF) of 50% reduction or more from baseline. Three weeks later, participants were challenged with a cumulative dose equal to the sum of all the allergen doses received at screening. TNSS and PNIF were recorded at regular intervals, including a 24-hour assessment. A subsequent visit was conducted after a further 3 weeks. Nasal secretion samples were collected for cytokine and eosinophil quantification. RESULTS: Nine participants completed all visits. TNSS and PNIF responses followed previous patterns, with an initial peak at 30 minutes followed by a gradual decline. Most participants reported similar patterns at both NAC visits, although some did not demonstrate the same phenotype at both visits. Some experienced a secondary symptom increase 24 hours after NAC. Eosinophil and cytokine sections followed a similar pattern at both NAC visits. CONCLUSION: NAC is an adequate method for modeling AR in humans, demonstrating appropriate repeatability of symptoms, nasal mucosal eosinophil, and cytokines. The 24-hour time point, previously not studied in our model, may be beneficial in evaluation of long-acting medications. This three-week interval NAC model will be beneficial for studies in which before and after treatment comparisons are desired. SN - 1534-4436 UR - https://www.unboundmedicine.com/medline/citation/29432965/Repeatability_of_nasal_allergen_challenge_results:_Further_validation_of_the_allergic_rhinitis_clinical_investigator_collaborative_protocols_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(18)30118-2 DB - PRIME DP - Unbound Medicine ER -