Mind the gaps

Clinical trial concepts to address unanswered questions in aeroallergen immunotherapy—An NIAID/AHRQ Workshop

Lisa M. Wheatley, Robert Wood, Kari Nadeau, Andrew Liu, Edward Zoratti, Leonard Bacharier, Erica Brittain, Moises Calderon, Thomas Casale, Bradley Chipps, Linda Cox, Peter S. Creticos, Manisha Desai, Sten Dreborg, Stephen Durham, Peter J. Gergen, Rebecca Gruchalla, Harold Nelson, Robyn E. O'Hehir, Marshall Plaut & 5 others Julie M. Schwaninger, Stephen Tilles, Brian Vickery, Kim M. Wittenberg, Alkis Togias

Research output: Contribution to journalArticleOtherpeer-review

3 Citations (Scopus)

Abstract

The Agency for Healthcare Research and Quality and the National Institute of Allergy and Infectious Diseases organized a workshop to develop trial concepts that could improve the use and effectiveness of aeroallergen immunotherapy (AAIT). Expert groups were formed to accomplish the following tasks: (1) propose a study design to compare the effectiveness and safety of subcutaneous versus sublingual AAIT; (2) propose a study design to compare the effectiveness and safety of AAIT by using 1 or a few allergens versus all or most allergens to which a patient is sensitized; (3) propose a study design to determine whether AAIT can alter the progression of childhood allergic airways disease; and (4) propose a study design to determine the optimal dose and duration of AAIT to achieve maximal effectiveness with acceptable safety. Study designs were presented by the workgroups, extensively discussed at the workshop, and revised for this report. The proposed trials would be of long duration and require large highly characterized patient populations. Scientific caveats and feasibility matters are discussed. These concepts are intended to help the development of clinical trials that can address some of the major questions related to the practice of AAIT for the management and prevention of allergic airways disease.

Original languageEnglish
Number of pages16
JournalJournal of Allergy and Clinical Immunology
DOIs
Publication statusAccepted/In press - 1 Jan 2019

Keywords

  • Aeroallergen
  • allergic rhinitis
  • asthma
  • immunotherapy
  • multi-allergen
  • prevention
  • rhinoconjunctivitis

Cite this

Wheatley, Lisa M. ; Wood, Robert ; Nadeau, Kari ; Liu, Andrew ; Zoratti, Edward ; Bacharier, Leonard ; Brittain, Erica ; Calderon, Moises ; Casale, Thomas ; Chipps, Bradley ; Cox, Linda ; Creticos, Peter S. ; Desai, Manisha ; Dreborg, Sten ; Durham, Stephen ; Gergen, Peter J. ; Gruchalla, Rebecca ; Nelson, Harold ; O'Hehir, Robyn E. ; Plaut, Marshall ; Schwaninger, Julie M. ; Tilles, Stephen ; Vickery, Brian ; Wittenberg, Kim M. ; Togias, Alkis. / Mind the gaps : Clinical trial concepts to address unanswered questions in aeroallergen immunotherapy—An NIAID/AHRQ Workshop. In: Journal of Allergy and Clinical Immunology. 2019.
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abstract = "The Agency for Healthcare Research and Quality and the National Institute of Allergy and Infectious Diseases organized a workshop to develop trial concepts that could improve the use and effectiveness of aeroallergen immunotherapy (AAIT). Expert groups were formed to accomplish the following tasks: (1) propose a study design to compare the effectiveness and safety of subcutaneous versus sublingual AAIT; (2) propose a study design to compare the effectiveness and safety of AAIT by using 1 or a few allergens versus all or most allergens to which a patient is sensitized; (3) propose a study design to determine whether AAIT can alter the progression of childhood allergic airways disease; and (4) propose a study design to determine the optimal dose and duration of AAIT to achieve maximal effectiveness with acceptable safety. Study designs were presented by the workgroups, extensively discussed at the workshop, and revised for this report. The proposed trials would be of long duration and require large highly characterized patient populations. Scientific caveats and feasibility matters are discussed. These concepts are intended to help the development of clinical trials that can address some of the major questions related to the practice of AAIT for the management and prevention of allergic airways disease.",
keywords = "Aeroallergen, allergic rhinitis, asthma, immunotherapy, multi-allergen, prevention, rhinoconjunctivitis",
author = "Wheatley, {Lisa M.} and Robert Wood and Kari Nadeau and Andrew Liu and Edward Zoratti and Leonard Bacharier and Erica Brittain and Moises Calderon and Thomas Casale and Bradley Chipps and Linda Cox and Creticos, {Peter S.} and Manisha Desai and Sten Dreborg and Stephen Durham and Gergen, {Peter J.} and Rebecca Gruchalla and Harold Nelson and O'Hehir, {Robyn E.} and Marshall Plaut and Schwaninger, {Julie M.} and Stephen Tilles and Brian Vickery and Wittenberg, {Kim M.} and Alkis Togias",
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Wheatley, LM, Wood, R, Nadeau, K, Liu, A, Zoratti, E, Bacharier, L, Brittain, E, Calderon, M, Casale, T, Chipps, B, Cox, L, Creticos, PS, Desai, M, Dreborg, S, Durham, S, Gergen, PJ, Gruchalla, R, Nelson, H, O'Hehir, RE, Plaut, M, Schwaninger, JM, Tilles, S, Vickery, B, Wittenberg, KM & Togias, A 2019, 'Mind the gaps: Clinical trial concepts to address unanswered questions in aeroallergen immunotherapy—An NIAID/AHRQ Workshop', Journal of Allergy and Clinical Immunology. https://doi.org/10.1016/j.jaci.2019.01.032

Mind the gaps : Clinical trial concepts to address unanswered questions in aeroallergen immunotherapy—An NIAID/AHRQ Workshop. / Wheatley, Lisa M.; Wood, Robert; Nadeau, Kari; Liu, Andrew; Zoratti, Edward; Bacharier, Leonard; Brittain, Erica; Calderon, Moises; Casale, Thomas; Chipps, Bradley; Cox, Linda; Creticos, Peter S.; Desai, Manisha; Dreborg, Sten; Durham, Stephen; Gergen, Peter J.; Gruchalla, Rebecca; Nelson, Harold; O'Hehir, Robyn E.; Plaut, Marshall; Schwaninger, Julie M.; Tilles, Stephen; Vickery, Brian; Wittenberg, Kim M.; Togias, Alkis.

In: Journal of Allergy and Clinical Immunology, 01.01.2019.

Research output: Contribution to journalArticleOtherpeer-review

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AU - Liu, Andrew

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AU - Creticos, Peter S.

AU - Desai, Manisha

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AU - Togias, Alkis

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KW - allergic rhinitis

KW - asthma

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KW - multi-allergen

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