Third Proceedings of The North American Airway Collaborative (NoAAC): Consensus Statement on Trial Design for Airway Stenosis

Ruth J. Davis, Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Wisconsin-Madison.
Lee M. Akst, Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Clint T. Allen, Surgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Richard J. Battafarano, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Hayley L. Born, Department of Otolaryngology-Head and Neck Surgery, Columbia University Irving Medical Center, New York, New York.
Paul C. Bryson, Head and Neck Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Matthew S. Clary, Department of Otolaryngology-Head and Neck Surgery, University of Colorado Anschutz Medical Center, Aurora.
Tyler Crosby, Department of Otolaryngology-Head and Neck Surgery, University of California, San Francisco.
Vaninder K. Dhillon, Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Greg Dion, Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Hannah Kavookjian, Department of Otolaryngology-Head and Neck Surgery, University of Kansas Medical Center, Kansas City.
Kevin P. Leahy, Department of Otorhinolaryngology, Head and Neck Surgery, University of Pennsylvania, Philadelphia.
Ioan Lina, Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Natasha Mirza, Department of Otorhinolaryngology, Head and Neck Surgery, University of Pennsylvania, Philadelphia.
Robert J. Morrison, Department of Otolaryngology-Head & Neck Surgery, University of Michigan Medical School, Ann Arbor.
Kevin M. Motz, Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Rebecca C. Nelson, Head and Neck Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Diego Preciado, Department of Pediatric Otolaryngology, Children's National Medical Center, Washington, DC.
Kishore Sandu, Department of Otorhinolaryngology, Head and Neck Surgery, Lausanne University Hospital (CHUV), Lausanne, Switzerland.
Joseph R. Spiegel, Department of Otolaryngology-Head and Neck Surgery, Jefferson Voice and Swallowing Center, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.
Jonathan Walsh, Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Alexander T. Hillel, Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Alexander Gelbard, Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.

Document Type

Journal Article

Publication Date

1-23-2025

Journal

JAMA otolaryngology-- head & neck surgery

DOI

10.1001/jamaoto.2024.4963

Abstract

IMPORTANCE: Airway stenosis is a rare but debilitating disorder that significantly degrades the quality of life in affected patients. Treatments are primarily surgical, and disease management lacks established medical therapies. The North American Airway Collaborative held its third symposium at The Johns Hopkins Hospital in Baltimore, Maryland, on April 15, 2024, focused on strategies to advance the care of these patients. The proceedings summarize the discussion of trial design in airway stenosis and the resulting North American Airway Collaborative consensus regarding clinical end points for rigorous study of novel therapies. OBSERVATIONS: The lectures and panels centered on the translation of a growing body of preclinical data into therapeutic targets. Additionally, detailed discussion explored design of clinical trials to evaluate safety and efficacy of novel therapeutics. The need for a consensus regarding clinically meaningful end points in airway stenosis was identified to facilitate the comparison of outcomes across institutions and future multi-institutional trials. CONCLUSIONS AND RELEVANCE: The group achieved consensus regarding change in peak expiratory flow as the primary clinical end point in airway stenosis. Additional clinical measures, such as disease recurrence (identified as time to recurrent intervention), anatomical characterization of subglottic scar via axial computed tomography imaging, and patient-reported outcome measures (Clinical COPD Questionnaire [CCQ], Voice Handicap Index-10 [VHI-10], Eating Assessment Tool-10 [EAT-10], and 12-Item Short-Form Health Survey, version 2 [SF-12]) were identified as essential secondary outcomes.

Department

Surgery

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