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Background: In patients with asthma, bronchoconstriction and airway inflammation both contribute to airway narrowing and airflow limitations, which lead to symptoms and exacerbations. Short-acting β₂-agonist (SABA)-only rescue therapy addresses only bronchoconstriction and is associated with increased morbidity and mortality. Current asthma management guidelines recommend concomitant treatment of symptoms and inflammation with a fast-acting bronchodilator and inhaled corticosteroid (ICS) as rescue therapy for patients ≥12 years of age. However, there is an education and outreach gap for the wider adoption of anti-inflammatory rescue therapy in clinical practice. Objective: AstraZeneca has developed an education program for health-care practitioners (HCPs) based on a Knowledge-to-Action Framework, with the aim of increasing HCPs' understanding of key disease-state concepts related to evidence-based management of asthma. Methods: A multichannel, evidence-based education program was presented at medical conferences across the United States between December 2022 and December 2023. Before and after each event, attendees were asked to complete a survey that rated their agreement with six disease-state concepts on a five-point Likert scale. These concepts related to the role of airway inflammation, fluctuations in inflammation, SABA and ICS therapy, and the risk of exacerbations. Postevent responses to the survey were assessed relative to pre-event responses and longitudinally over 12 months by using calculated odds ratios and 95% confidence intervals. Acceptance and/or understanding of a concept was defined as a rating of "agree" or "strongly agree" from at least 80% of respondents. Results: The proportion of respondents who agreed or strongly agreed with each concept was significantly higher postevent versus pre-event (p < 0.001). The 80% acceptance and/or understanding threshold was surpassed for all concepts after the event. Conclusion: The medical education program improved understanding and/or acceptance of key disease-state concepts related to asthma management among participating HCPs. Effective communication of disease management concepts may lead to improved patient health outcomes through more rapid acceptance of guideline-recommended medical therapies.

Background: Asthma in children is a leading cause of missed school days, emergency department visits, and hospitalizations. Approximately 40% of children with asthma experience uncontrolled disease and annual exacerbations. There is a need for a validated composite tool for children, such as the Asthma Impairment and Risk Questionnaire (AIRQ), which was developed to assess current control and predict exacerbations in adolescents and adults with asthma., Objective: To obtain feedback from children with asthma and their parents/caregivers to inform development of a version of the AIRQ for pediatric use (Peds-AIRQ)., Methods: Children with asthma aged 5 to 11 years and their parents/caregivers participated in cognitive interviews to elicit language describing asthma symptoms and exacerbations and to assess understanding and relevance of draft Peds-AIRQ questions. Physicians and parents/caregivers provided clinical information and performed assessments relative to the children's asthma morbidity., Results: There were 60 dyads that participated: children's mean (SD) age = 7.9 (1.9) years; 68% male, 45% non-White, 32% Hispanic, and 40% with public health insurance. Overall, 53% had well-controlled, 30% partly controlled, and 17% uncontrolled asthma, based on the Global Initiative for Asthma symptom control questions. Oral or injected corticosteroids were used for asthma by 53% of the children in the previous year. Participants found draft Peds-AIRQ items understandable and relevant. Seven impairment and 3 risk questions were retained for validation, along with 5 additional items containing wording or control threshold variations., Conclusion: This study supports the need for developing a composite (impairment and risk) control tool to assess children aged 5 to 11 years with asthma and identified suitable questions for the validation of a Peds-AIRQ., Competing Interests: Disclosures Dr Lanz is a consultant for Amgen, AstraZeneca, Cogent, Genentech, Grifols, Novartis, and Sanofi/Regeneron; is a speaker for Amgen/AstraZeneca and Sanofi/Regeneron; and receives research grants from Regeneron, Sanofi, Genentech/Roche, and AstraZeneca. Dr Chipps has served as an advisor, consultant, and speaker for AstraZeneca, Boehringer Ingelheim, Circassia, Genentech, Novartis, Regeneron, and Sanofi. Dr Zeiger has received grants from Aerocrine, Genentech, MedImmune/AstraZeneca, Merck, GlaxoSmithKline, ALK Pharma, Teva, Sanofi, and the National Heart, Lung, and Blood Institute, has received consultant fees from AstraZeneca, Bayer, Genentech/Novartis, Merck, and Regeneron, and holds warrant shares in DBV Technologies. Dr Bacharier is a consultant for AstraZeneca, GlaxoSmithKline, Regeneron Pharmaceuticals Inc, Sanofi, Recludix, and Avillion; is a speaker for Sanofi and Regeneron; is a member of the data and safety monitoring board for AstraZeneca, Cystic Fibrosis Foundation/Vertex, Aravax, and DBV Technologies; and receives research support from the National Institutes of Health, AstraZeneca, and Sanofi. Dr Guilbert is a consultant for Amgen, AstraZeneca, Genentech, OM Pharma, Regeneron, and Sanofi; receives grants from Amgen, AstraZeneca, GlaxoSmithKline, OM Pharma, Regeneron, and Sanofi; and receives personal fees from Advent.com, AiCME, AstraZeneca, Genentech, OM Pharma, PlatformQ health, and Polarean. Dr Murphy has served as a consultant and is a speaker for AstraZeneca, Boehringer Ingelheim, Genentech, Greer, Merck, Mylan, Novartis, Regeneron, Sanofi, OptiNose, and Teva. Ms Winders is a consultant/speaker for ALK, AstraZeneca, Chiesi, Genentech, GlaxoSmithKline, Roche, Sanofi, and Regeneron. Dr Mohammad has participated on an advisory board for AstraZeneca. Ms LeNoir has participated on an advisory board for AstraZeneca and is a board member at Digital Health Equitable Alliance and African American Wellness Project. Dr Gilbert and Mr Eudicone are employees of AstraZeneca, the sponsor of this study, and may hold stock or stock options. Dr Coyne and Ms Harding are employees of Evidera, which was contracted by AstraZeneca for study design support, to collect and analyze data for this study, and to provide medical writing support. Dr George has served as a consultant to AstraZeneca, Insmed, and Teva and has served as a speaker for AstraZeneca and Regeneron., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Complex models combining impairment-based control assessments with clinical characteristics and biomarkers have been developed to predict asthma exacerbations. The composite Asthma Impairment and Risk Questionnaire (AIRQ) with adjustments for demographics (age, sex, race, and body mass index) predicts 12-month exacerbation occurrence similarly to these more complex models., Objective: To examine whether AIRQ exacerbation prediction is enhanced when models are adjusted for a wider range of clinical characteristics and biomarkers., Methods: Patients aged 12 years and older completed monthly online surveys regarding exacerbation-related oral corticosteroid use, emergency department or urgent care visits, and hospitalizations. Univariate logistic regressions to predict exacerbations were performed with sociodemographics, comorbidities, exacerbation history, lung function, blood eosinophils, IgE, and FeNO. Significant (P ≤ .05) variables were included in multivariable logistic regressions with and without AIRQ control categories to predict 12-month exacerbations (log odds ratio [95% Wald confidence interval]). Model performances were compared., Results: Over 12 months, 1,070 patients (70% female; mean [SD] age, 43.9 [19.4] years; 22% non-White; body mass index [SD], 30.6 [8.7]) completed one or more survey (mean [SD], 10.5 [2.8] surveys). In the multivariable analysis, AIRQ control category adjusted for significant clinical characteristics and biomarkers was predictive of one or more exacerbations: odds ratio (95% CI) not well-controlled versus well-controlled: 1.93 (1.41-2.62), very poorly controlled versus well-controlled: 3.81 (2.65-5.47). Receiver operating characteristic area under the curve (AUC) for this more complex model of exacerbation prediction (AUC = 0.72) did not differ from AIRQ (AUC = 0.70). Models with AIRQ performed better than those without AIRQ (AUC = 0.67; P < .05)., Conclusion: Costly and time-consuming complex modeling with clinical characteristics and biomarkers does not enhance the strong exacerbation prediction ability of AIRQ., (Copyright © 2024. Published by Elsevier Inc.)

Background: The Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item, yes/no, equally weighted control tool. Lower scores indicate better control. Moreover, 7 impairment items reflect previous 2-week symptoms, and 3 risk items assess previous 12-month exacerbations. The Follow-up AIRQ for use between annual assessments has a 3-month recall period for exacerbation items., Objective: To evaluate the responsiveness of the AIRQ over time and identify a minimal important difference (MID)., Methods: The AIRQ longitudinal study data were analyzed from patients with asthma aged 12 years and older. Anchor-based methods assessed differences in AIRQ scores relative to Patient Global Impression of Change, the accepted MIDs for St. George's Respiratory Questionnaire and Asthma Control Test, and exacerbation occurrence over 12 months. Baseline and 12-month data reflected 12-month recall AIRQ scores; Follow-up AIRQ scores were used for 3-, 6-, and 9-month analyses., Results: A total of 1070 patients were included. The Patient Global Impression of Change rating of "much improved" was associated with AIRQ mean score changes from baseline to months 3, 6, 9, and 12 of -2.0, -1.9, -1.9, and -1.8, respectively. The mean AIRQ score change among patients who met the St. George's Respiratory Questionnaire MID (≥4-point decrease) was -1.8 at 6 and 12 months. The AIRQ mean scores decreased from baseline by -2.2 to -2.5 points at months 3, 6, 9, and 12 for patients who met the Asthma Control Test MID (≥ 3-point increase). A 2-point higher baseline AIRQ score was associated with a 1.7 odds ratio of 12-month exacerbation occurrence (95% CI, 1.53-1.89)., Conclusion: A change score of 2 is recommended as the AIRQ MID., Competing Interests: Disclosures Dr McCann has served as a consultant and speaker for AstraZeneca, a speaker for Regeneron, and a consultant for Aimmune and Genentech. Dr Murphy has served as a consultant and is a speaker for AstraZeneca, Boehringer Ingelheim, Genentech, Greer, Merck, Mylan, Novartis, Regeneron, Sanofi, Optinose, and Teva. Dr Zeiger has received grants from Aerocrine, Genentech, MedImmune/AstraZeneca, Merck, GlaxoSmithKline, Teva, Quest, Sanofi, and the National Heart, Lung, and Blood Institute; has completed consultant activity for AstraZeneca, Regeneron, Merck, Genentech/Novartis, and Bayer; and holds warrant shares in DBV Technologies. Dr Beuther has participated in advisory boards for AstraZeneca. Dr Wise received consultant fees and honoraria from AstraZeneca, GlaxoSmithKline, Novartis, Boehringer Ingelheim, ContraFect, Pulmonx, Roche, Regeneron, AbbVie, Spiration, Sunovion, Merck, Circassia, Pneuma, Verona, Bonti, Denali, Aradigm, Mylan, Theravance, Propeller Health, Kiniksa, and Syneos. Dr Reibman has served as an advisory committee member for AstraZeneca, received grant/research support from Novartis, served on an advisory board for Novartis and Genentech, and participated in clinical trials funded by AstraZeneca, Novartis, and Teva. Dr George has served as a consultant and speaker to AstraZeneca, Regeneron, and Sanofi. Dr Gilbert and Mr Eudicone are employees of AstraZeneca. Dr Gandhi was an employee of AstraZeneca at the time this work was completed and is a current employee of Alexion, AstraZeneca Rare Disease. Ms Cutts and Dr Coyne are employees of Evidera, which was contracted by AstraZeneca for study design and to collect and analyze data for this study. Dr Chipps has served as an advisor, consultant, and speaker for AstraZeneca, Boehringer Ingelheim, Circassia, Genentech, Novartis, Regeneron, and Sanofi., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: National and international asthma guidelines and reports do not include control tools that combine impairment assessment with exacerbation history in one instrument., Objective: To analyze the performance of the composite Asthma Impairment and Risk Questionnaire (AIRQ) in assessing both domains of control and predicting exacerbation risk compared with the Global Initiative for Asthma (GINA) 4-question symptom control tool (GINA SCT), Asthma Control Test (ACT), and physician expert opinion (EO) informed by GINA SCT responses and appraisal of GINA-identified risk factors for poor asthma outcomes., Methods: Multivariable logistic regressions evaluated AIRQ and GINA SCT as predictors of ACT. McNemar's test compared the proportion of patients categorized at baseline as completely or well-controlled by each assessment but with current impairment or previous-year and subsequent-year exacerbations., Results: The analysis included 1064 patients aged 12 years or older; mean (SD) age 43.8 years (19.3); 70% female; 79% White; and 6% Hispanic or Latino. AIRQ and GINA SCT were highly predictive of ACT well-controlled vs not well-controlled and very poorly controlled (receiver operator characteristic area under curve AIRQ = 0.90, GINA SCT = 0.86, P = .03 AIRQ vs GINA SCT) and ACT very poorly controlled vs well-controlled and not well-controlled asthma (receiver operator characteristic area under curve AIRQ = 0.91, GINA SCT = 0.87, P = .01 AIRQ vs GINA SCT). AIRQ rated fewer patients as having completely or well-controlled asthma who had current impairment (P < .01) or with previous-year and subsequent-year exacerbations (P < .001) than did GINA SCT, ACT, and EO., Conclusion: AIRQ performs better in assessing both domains of current control and predicting exacerbation risk than do control tools and EO informed by GINA SCT and risk factors for poor asthma outcomes., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Asthma control is often overestimated in routine practice, and despite advances in the understanding of immunopathology and the availability of new precision therapies, the burden of disease remains unacceptably high., Objective: To compare the performance of the Asthma Impairment and Risk Questionnaire (AIRQ) with patient and physician assessments and the Asthma Control Test (ACT) in identifying asthma control., Methods: Baseline data from a longitudinal study of the AIRQ were analyzed. Patients with asthma in the United States aged 12 years and older followed in 24 specialty practices and 1 specialty-affiliated primary care clinic were enrolled between May and November 2019. At entry, participants completed AIRQ and ACT, and participants and physicians completed 5-point Likert scale assessments of control., Results: A total of 1112 participants were enrolled (mean [SD] age = 43.9 [19.3] years, 70% of the female sex, 78% White). Overall, 62% of participants rated themselves as well- or completely controlled, and 54% were rated comparably by physicians. The ACT classified 49% of participants as well-controlled, with 35% similarly categorized by AIRQ. Previous-year exacerbations were experienced by 32% of participants who self-rated as well- or completely controlled, 30% who were rated as well- or completely controlled by physicians, and 29% assessed as well-controlled by ACT, but only 15% of those classified as well-controlled by AIRQ., Conclusion: The burden of asthma is substantial in patients cared for by asthma specialists, and asthma control is overestimated by patients, physicians, and the symptom-based ACT. The AIRQ assesses risk in addition to symptom control and may serve to improve asthma control determination by assessing previous exacerbations., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item, equally weighted, yes/no control tool validated in patients with asthma aged 12 years and older., Objective: To evaluate AIRQ's ability to predict patient-reported exacerbations over 12 months., Methods: Patients completed a baseline AIRQ during an in-person enrollment visit and reported exacerbations (ie, asthma-related courses of oral corticosteroids, emergency department/urgent care visits, and hospitalizations) via monthly online surveys. Logistic regressions were performed using AIRQ control level (well-controlled [WC], not well-controlled [NWC], very poorly controlled [VPC]), age, sex, race, and body mass index as covariates and 1 or more and 2 or more exacerbations as the dependent variables (adjusted odds ratios [OR] and 95% Wald CIs). Kaplan-Meier analyses of time to first exacerbation by AIRQ control level were performed., Results: A total of 1,112 patients were enrolled; 1,070 completed 1 or more surveys over 12 months (mean ± SD 10.5 ± 2.8 months); 70.5% female; age 43.9 ± 19.3 years; 20.4% non-White; body mass index 30.6 ± 8.7 kg/m 2 ; AIRQ: WC 35.2%, NWC 38.1%, VPC 26.6%. A total of 45.7% of patients reported 1 or more exacerbations and 26.7% 2 or more exacerbations (WC 28.4% ≥ 1, 11.1% ≥ 2; NWC 46.3% ≥ 1, 27.9% ≥ 2; VPC 67.7% ≥ 1, 45.6% ≥ 2). The ORs for 1 or more exacerbations NWC versus WC were 2.1 (CI 1.6-2.9), and VPC versus WC were 4.6 (CI 3.3-6.5). The ORs for 2 or more exacerbations NWC versus WC were 3.1 (CI 2.1-4.6), and VPC versus WC were 6.1 (CI 4.0-9.1). Kaplan-Meier curves demonstrated clear differentiation of time to first exacerbation by AIRQ control level (P < .001)., Conclusions: The AIRQ control level predicts exacerbation risk over 12 months and probability of time to first exacerbation., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Recurrent assessment of asthma control is essential to evaluating disease stability and intervention impacts. An assessment that can be administered between annual clinic visits is needed. The Asthma Impairment and Risk Questionnaire (AIRQ) is a cross-sectionally validated, 10-item, yes or no, composite control tool evaluating previous 2-week symptoms and previous 12-month exacerbations., Objective: To evaluate the construct validity of the AIRQ using a 3-month recall period for exacerbation-based risk questions and retaining the 2-week recall for symptom-based impairment items., Methods: At baseline, patients completed the AIRQ with 12-month recall exacerbation items, Asthma Control Test (ACT), St. George's Respiratory Questionnaire (SGRQ), and global self-assessments of asthma risk, control, and symptom severity. Patient-reported exacerbations were captured monthly. The AIRQ with 3-month recall exacerbation items, ACT, and global self-assessments was administered at months 3, 6, and 9, and SGRQ at month 6., Results: A total of 1112 patients aged 12 years or older were enrolled (mean [SD] age, 43.9 [19.5] years). The AIRQ and each administration of the AIRQ with 3-month recall exacerbation items classified asthma control similarly to an ACT plus exacerbation validation standard. For both AIRQ versions, SGRQ scores were higher with worsening asthma control (P < .001). At months 3, 6, and 9, worse AIRQ control levels were associated with higher proportions of patients with 1 or more and 2 or more exacerbations in the previous 3 months and patient global self-assessments indicating greater asthma morbidity (all P < .001)., Conclusion: The AIRQ using exacerbation risk items with a 3-month recall period exhibits construct validity for classifying current asthma control and can be administered between annual AIRQ assessments., (Copyright © 2022 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: A variety of dual-combination maintenance inhalers are used to treat asthma and chronic obstructive pulmonary disease (COPD). Understanding patient preferences for treatment attributes may help select an optimal treatment from the patient perspective., Methods: Patient preferences for maintenance inhaler device and medication attributes were elicited through a discrete choice experiment and used in benefit-risk assessments to calculate predicted choice probabilities (PrCPs) for 14 dual-combination maintenance inhalers in four treatment classes: lower- and higher-dose inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) inhalers for asthma, and ICS/LABA and long-acting muscarinic antagonist (LAMA)/LABA inhalers for COPD., Results: For all treatment classes, reduced exacerbations and faster onset of action were the most important attributes. For all classes, patients were willing to tolerate an extra yearly exacerbation to decrease the medication's onset of action from 30 to 5 min. For patients with asthma using lower-dose ICS/LABA (n = 497), budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pressurized metered-dose inhaler (pMDI) had the highest PrCP (28.4%), and for those using a higher-dose ICS/LABA (n = 285), PrCPs were highest for mometasone furoate/formoterol fumarate dihydrate (200 μg/5 μg) pMDI (27.0%) and budesonide/formoterol fumarate dihydrate (160 μg/4.5 μg) pMDI (26.9%). For patients with COPD using an ICS/LABA (n = 574), budesonide/formoterol fumarate dihydrate (160 μg/4.5 μg) pMDI had the highest PrCP (56.6%), and for those using a LAMA/LABA inhaler (n = 217), tiotropium/olodaterol (2.5 μg/2.5 μg) soft mist inhaler had the highest PrCP (42.3%)., Conclusions: Patient preference data for maintenance inhaler attributes can be used to identify a preference order of inhalers in different treatment classes., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Asthma exacerbation risk increases with worsening asthma control. Prevailing numerical control tools evaluate only current symptom impairment despite the importance of also assessing risk based on exacerbation history. An easy-to-use questionnaire addressing impairment and risk domains of control is needed., Objective: To validate a composite asthma control tool that includes impairment and risk assessments (Asthma Impairment and Risk Questionnaire [AIRQ])., Methods: Four-hundred forty-two patients aged ≥12 years with physician-diagnosed asthma who were followed in specialty practices completed 15 impairment and risk questions with dichotomized yes/no responses. Patients spanned all Global Initiative for Asthma severities and were classified as well-controlled, not well-controlled, or very poorly controlled according to a standard of Asthma Control Test (ACT) score plus prior-year exacerbations. Logistic regression analyses identified questions with the greatest predictive validity to discriminate among patients and determine cut points for these 3 classifications., Results: The final AIRQ comprises 10 equally weighted yes/no impairment and risk questions. The final 10-item models yielded receiver operating characteristic curves of 0.94 to identify well-controlled versus not well-/very poorly controlled and 0.93 to identify well-/not well-controlled versus very poorly controlled asthma, as reflected by the ACT plus prior-year exacerbations standard. Cut points of 0-1, 2-4, and 5-10 best represented well-, not well-, and very poorly controlled asthma., Conclusions: AIRQ is a rigorously validated composite measure designed to identify adults and adolescents with varying degrees of asthma control. Ongoing investigations will determine test-retest reliability, responsiveness to change, and predictive ability for future exacerbations., (Copyright © 2020 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)