Purpose: Decentralized clinical trials, where trial-related activities occur at locations other than traditional clinical sites (eg participant homes, local healthcare facilities), have the potential to improve trial access for people for whom time and/or distance constraints may impede participation.Albuterol-budesonide 180/160 µg pressurized metered-dose inhaler (pMDI) is FDA approved for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years or older.BATURA (NCT05505734) is a fully decentralized study, investigating as-needed albuterol-budesonide in participants with mild asthma.Methods: BATURA is a fully decentralized, phase 3b, randomized, double-blind, event-driven exacerbation study conducted in the United States.Participants aged ≥12 years using as-needed short-acting β 2 -agonist (SABA), alone or with low-dose inhaled corticosteroid or leukotriene receptor antagonist maintenance, are randomized 1:1 to as-needed albuterol-budesonide 180/160 µg or albuterol 180 µg pMDI for up to 52 weeks (minimum 12 weeks).Participants continue their current maintenance therapy, if applicable.Participants must have used SABA for ≥2 days in the 2 weeks pre-enrollment and have an Asthma Impairment Risk Questionnaire score ≥2 at screening and randomization.All trial-related visits, including screening and consent, are conducted virtually, with study medication shipped directly to each participant's residence.The primary objective is to evaluate the efficacy of as-needed albuterol-budesonide versus albuterol on severe asthma exacerbation risk, measured by time-to-first severe asthma exacerbation (primary endpoint).Secondary endpoints include annualized rate of severe asthma exacerbation and total systemic corticosteroid exposure.Study medication use is captured via a Hailie sensor attached to the study medication pMDI.The intended sample size is 2500 participants.Conclusion: BATURA evaluates as-needed albuterol-budesonide in participants with mild asthma.The decentralized study model enables the trial to move out of research sites into participant homes, reducing participant burden and improving access.
BACKGROUND:As asthma symptoms worsen, patients typically rely on short-acting β2-agonist (SABA) rescue therapy, but SABAs do not address worsening inflammation, which leaves patients at risk for severe asthma exacerbations. The use of a fixed-dose combination of albuterol and budesonide, as compared with albuterol alone, as rescue medication might reduce the risk of severe asthma exacerbation.METHODS:We conducted a multinational, phase 3, double-blind, randomized, event-driven trial to evaluate the efficacy and safety of albuterol-budesonide, as compared with albuterol alone, as rescue medication in patients with uncontrolled moderate-to-severe asthma who were receiving inhaled glucocorticoid-containing maintenance therapies, which were continued throughout the trial. Adults and adolescents (≥12 years of age) were randomly assigned in a 1:1:1 ratio to one of three trial groups: a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide (with each dose consisting of two actuations of 90 μg and 80 μg, respectively [the higher-dose combination group]), a fixed-dose combination of 180 μg of albuterol and 80 μg of budesonide (with each dose consisting of two actuations of 90 μg and 40 μg, respectively [the lower-dose combination group]), or 180 μg of albuterol (with each dose consisting of two actuations of 90 μg [the albuterol-alone group]). Children 4 to 11 years of age were randomly assigned to only the lower-dose combination group or the albuterol-alone group. The primary efficacy end point was the first event of severe asthma exacerbation in a time-to-event analysis, which was performed in the intention-to-treat population.RESULTS:A total of 3132 patients underwent randomization, among whom 97% were 12 years of age or older. The risk of severe asthma exacerbation was significantly lower, by 26%, in the higher-dose combination group than in the albuterol-alone group (hazard ratio, 0.74; 95% confidence interval [CI], 0.62 to 0.89; P = 0.001). The hazard ratio in the lower-dose combination group, as compared with the albuterol-alone group, was 0.84 (95% CI, 0.71 to 1.00; P = 0.052). The incidence of adverse events was similar in the three trial groups.CONCLUSIONS:The risk of severe asthma exacerbation was significantly lower with as-needed use of a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide than with as-needed use of albuterol alone among patients with uncontrolled moderate-to-severe asthma who were receiving a wide range of inhaled glucocorticoid-containing maintenance therapies. (Funded by Avillion; MANDALA ClinicalTrials.gov number, NCT03769090.).
What is this summary about? This summary describes the results of a clinical study called MANDALA that was published in the New England Journal of Medicine in 2022. In the MANDALA study, researchers looked at a new asthma rescue inhaler that contains both albuterol and budesonide in a single inhaler (known as albuterol–budesonide, AIRSUPRA™). This summary describes the results for people aged 18 yearsand older who took part in the study.
SESSION TITLE: Allergy and Airway Posters 2 SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/10/2023 12:00 pm - 12:45 pm PURPOSE: Albuterol–budesonide pMDI was FDA-approved January 2023 for as-needed (prn) treatment or prevention of bronchoconstriction and to reduce exacerbation risk in patients ≥18yr with asthma. Approval relied on the MANDALA study, where prn albuterol–budesonide 180/160µg significantly reduced severe exacerbation risk by 27% vs albuterol in symptomatic patients ≥12yr with moderate-to-severe asthma and ≥1 severe exacerbation in the prior year receiving inhaled corticosteroid (ICS)-containing maintenance therapy. Here we describe BATURA, an ongoing Phase 3b study evaluating prn albuterol–budesonide safety and efficacy in participants with mild asthma. METHODS: BATURA is a fully decentralized, US, multicenter, randomized, double-blind, event-driven, asthma exacerbation study (NCT05505734). Participants aged ≥12yr using prn short-acting β2-agonist (SABA) alone or with low-dose ICS or leukotriene receptor agonist maintenance are randomized to prn albuterol–budesonide 180/160µg or albuterol 180µg for ≥12 weeks (max. 52 weeks). Participants must have used SABA on ≥2 days in the 2 weeks pre–enrollment and have an Asthma Impairment and Risk Questionnaire (AIRQTM) score ≥2. Participants continue their own maintenance therapy, if applicable. All visits, including screening and consent, are conducted virtually with study medication directly shipped to the participant. The primary objective is to evaluate the efficacy of prn albuterol–budesonide vs albuterol on severe asthma exacerbation risk; primary endpoint is time to first severe exacerbation, as in MANDALA. Secondary endpoints are annualized severe exacerbation rates and total systemic corticosteroid exposure. Safety endpoints are adverse events. Study medication use is captured electronically (Hailie® sensor). Intended sample size is 1910 (max. 2500), with a planned unblinded interim analysis when 172 severe exacerbation events (50% of target number) have occurred, to assess if the study may be stopped early for success. RESULTS: The first participant enrolled in September 2022. The study will continue (unless stopped at interim analysis for overwhelming efficacy) until either 350 severe exacerbations have occurred or the last randomized participant completes 12 months’ treatment. CONCLUSIONS: BATURA evaluates prn albuterol–budesonide efficacy and safety in participants ≥12yr with mild asthma. The decentralized virtual study model enables the trial to move out of the research site and into the participant’s home, thus reducing participant burden. CLINICAL IMPLICATIONS: Using a decentralized delivery model, BATURA aims to reach people who may not consider participating in clinical studies due to time/distance constraints, improving access for typically under-represented populations. Although albuterol–budesonide is approved across all asthma severities, BATURA will provide data from those with mild disease. DISCLOSURES: Employee relationship with Avillion LLP Please note: since 06/03/2019 Added 04 /03 /2023 by Frank Albers, source=Web Response, value=Salary Employee relationship with AstraZeneca Please note: July 2000 Added 04/04/2023 by Christy Cappelletti, source=Web Response, value=hold stock Employee relationship with AstraZeneca Please note: 2015 to date Added 04/03/2023 by Mark Cooper, source=Web Response, value=Salary No relevant relationships by Anna Danilewicz Employee relationship with AstraZeneca Please note: 01/05/2019 Added 04/03/2023 by Lynn Dunsire, source=Web Response, value=Shareholder Conduct Clinical Trials relationship with Avillion Please note: 2020-current Added 04/03/2023 by Craig LaForce, source=Web Response, value=Grant/Research Conduct Clinical Trial relationship with Amphastar Please note: 2020-Current Added 04/03/2023 by Craig LaForce, source=Web Response, value=Grant/Research Support Conduct Clinical Trial relationship with Chiesi Please note: 2020-Current Added 04/03/2023 by Craig LaForce, source=Web Response, value=Grant/Research Support Conduct Clinical Trial relationship with Novartis Please note: 2020-2022 Added 04/03/2023 by Craig LaForce, source=Web Response, value=Grant/Research Support Conduct Clinical Trial relationship with AstraZeneca Please note: 2020-Current Added 04/03/2023 by Craig LaForce, source=Web Response, value=Grant/Research Support No relevant relationships by Robert Rees
BACKGROUND: In the phase 3 MANDALA trial, as-needed albuterol-budesonide pressurized metered-dose inhaler significantly reduced severe exacerbation risk vs as-needed albuterol in patients with moderate-to-severe asthma receiving inhaled corticosteroid-containing maintenance therapy. This study (DENALI) was conducted to address the US Food and Drug Administration combination rule, which requires a combination product to demonstrate that each component contributes to its efficacy.RESEARCH QUESTION: Do both albuterol and budesonide contribute to the efficacy of the albuterol-budesonide combination pressurized metered-dose inhaler in patients with asthma?STUDY DESIGN AND METHODS: This phase 3 double-blind trial randomized patients aged >= 12 years with mild-to-moderate asthma 1:1:1:1:1 to four-times-daily albuterol-budesonide 180/ 160 mu g or 180/80 mu g, albuterol 180 mu g, budesonide 160 mu g, or placebo for 12 weeks. Dual primary efficacy end points included change from baseline in FEV1 area under the curve from 0 to 6 h (FEV1 AUC(0-6h)) over 12 weeks (assessing albuterol effect) and trough FEV1 at week 12 (assessing budesonide effect).RESULTS: Of 1,001 patients randomized, 989 were >= 12 years old and evaluable for efficacy. Change from baseline in FEV1 AUC(0-6h) over 12 weeks was greater with albuterol-budesonide 180/160 mu g vs budesonide 160 mu g (least-squares mean [LSM] difference, 80.7 [95% CI, 28.4-132.9] mL; P 1/4 .003). Change in trough FEV1 at week 12 was greater with albuterol-budesonide 180/160 and 180/80 mu g vs albuterol 180 mu g (LSM difference, 132.8 [95% CI, 63.6-201.9] mL and 120.8 [95% CI, 51.5-190.1] mL, respectively; both P < .001). Day 1 time to onset and duration of bronchodilation with albuterol-budesonide were similar to those with albuterol. The albuterol-budesonide adverse event profile was similar to that of the monocomponents.INTERPRETATION: Both monocomponents contributed to albuterol-budesonide lung function efficacy. Albuterol-budesonide was well tolerated, even at regular, relatively high daily doses for 12 weeks, with no new safety findings, supporting its use as a novel rescue therapy.
SESSION TITLE: Other Topics in Asthma Abstract Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/18/2022 01:30 pm - 02:30 pm PURPOSE: The Phase 3 DENALI study (NCT03847896) showed albuterol-budesonide (ABD) in a single inhaler given four times daily (QID) over 12 weeks was more efficacious than the mono-components in improving lung function. As ABD is intended as rescue therapy, examining its effects vs albuterol over shorter periods when patients may temporarily require frequent dosing for increasing symptoms is important. METHODS: DENALI randomized 1001 patients with mild-to-moderate asthma 1:1:1:1:1 to ABD 180/160μg or 180/80μg, albuterol 180μg (A), budesonide 160μg or placebo, all QID, for 12 weeks. Change from pre-dose (Day 1) in forced expiratory volume in 1 second area under the curve from 0–6 hours (FEV1 AUC0-6) was measured over 12 weeks. Using a repeated measures model, this analysis estimated least squares mean (LSM) differences (95% confidence intervals [CI]) in change from Day 1 pre-dose FEV1 AUC0-6 for treatment comparisons of A and both ABD strengths to placebo and both ABD strengths to A at Day 1 and Weeks 1 and 4 in patients ≥12 years. RESULTS: 790 patients were included in this analysis (63% female): ABD 180/160µg (n=197), ABD 180/80µg (n=201), A (n=196), placebo (n=196). Overall, mean age was 48–50 years and Day 1 mean pre-dose FEV1 was 2.10–2.20 L (68–70% predicted). Day 1 LSM FEV1 AUC0-6 was greater with ABD 180/160µg (241 mL), ABD 180/80µg (209 mL), and A (213 mL) than placebo (109 mL) (LSM difference [95% CI] vs placebo: 132 [87–176] mL, 100 [56–144] mL, and 103 [59–148] mL, respectively). On Day 1, FEV1 AUC0-6 was similar between A and either strength of ABD. FEV1 AUC0-6 remained greater for both strengths of ABD vs placebo at Week 1 (LSM differences [95% CI]: ABD 180/160µg, 134 [75–193] mL and ABD 180/80µg, 121 [62–180] mL) and at Week 4 (LSM differences [95% CI]: ABD 180/160µg, 179 [117–240] mL and ABD 180/80µg, 168 [107–230] mL). There were smaller differences for A vs placebo at Weeks 1 or 4 (LSM differences [95% CI]: 44 [-16–103] mL and 42 [-20–104] mL, respectively). FEV1 AUC0-6 was also greater for ABD 180/160µg and 180/80µg vs A at Week 1 (LSM differences [95% CI]: 90 [31–150] mL and 77 [18–136] mL, respectively) and Week 4 (LSM differences [95% CI]: 137 [75–199] mL and 126 [65–188] mL, respectively). CONCLUSIONS: No appreciable difference was found in improvement in FEV1 between ABD and A when initiating treatment. With repeated use over 1–4 weeks, there were smaller differences between A and placebo, whereas the differences between ABD vs A and P increased. CLINICAL IMPLICATIONS: In the weeks surrounding an exacerbation, rescue bronchodilator use increases with worsening symptoms and decreasing lung function. Our results suggest that with frequent rescue inhaler use over 1–4 weeks, patients may no longer have the same benefit in lung function from albuterol alone; however, albuterol plus budesonide in a single inhaler may continue to improve lung function. DISCLOSURES: No relevant relationships by Frank Albers Scientific medical adviser relationship with AstraZeneca Please note: 24 months Added 04/05/2022 by Richard Beasley, value=Honoraria Scientific Medical Advisor relationship with Avillion Please note: 24 months Added 04/06/2022 by Richard Beasley, value=Consulting fee no disclosure on file for John Bell; no disclosure on file for Christy Cappelletti; Speaker/Speaker's Bureau relationship with AstraZeneca Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria Speaker/Speaker's Bureau relationship with Boeringer Ingelheim Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria Speaker/Speaker's Bureau relationship with Genentech Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria Consultant relationship with GlaxoSmithKline Please note: $5001 - $20000 by Bradley Chipps, value=Consulting fee Speaker/Speaker's Bureau relationship with Novartis Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria Speaker/Speaker's Bureau relationship with Regeneron Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria Speaker/Speaker's Bureau relationship with Sanofi Genzyme Please note: $5001 - $20000 by Bradley Chipps, value=Honoraria no disclosure on file for Anna Danilewicz; Employee relationship with AstraZeneca Please note: 05/05/2020 Added 04/18/2022 by Lynn Dunsire, value=Salary Employee relationship with AstraZeneca Please note: 05/05/2022 Added 04/18/2022 by Lynn Dunsire, value=Shareholder Employee relationship with AstraZeneca Please note: >$100000 by Ileen Gilbert, value=Salary Stock relationship with AstraZeneca Please note: $20001 - $100000 by Ileen Gilbert, value=Stock My spouse/partner as a Consultant relationship with Abott Please note: $20001 - $100000 by Ileen Gilbert, value=Consulting fee Employee relationship with AstraZeneca Please note: Ongoing Added 03/30/2022 by Ileen Gilbert, value=Salary Employee relationship with AstraZeneca AB Please note: Since 2008 Added 04/05/2022 by Per Gustafson, value=Salary no disclosure on file for Elliot Israel; Advisory Committee Member relationship with AstraZeneca Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Consultant relationship with AstraZeneca Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Speaker/Speaker's Bureau relationship with AstraZeneca Please note: 24 months by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Advisory Committee Member relationship with RIFM Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Consultant relationship with RIFM Please note: 24 months by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Advisory Committee Member relationship with Equillium Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Advisory Committee Member relationship with Equillium Please note: 24 months by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Advisory Committee Member relationship with Genetech Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Speaker/Speaker's Bureau relationship with Genetech Please note: 24 months by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Speaker/Speaker's Bureau relationship with Sanofi/Regeneron Please note: 24 months by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Consultant relationship with Bayer Please note: 24 months by Reynold Panettieri, value=Honoraria Advisory Committee Member relationship with Theravance Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Advisory Committee Member relationship with Novartis Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Contracted Research relationship with Optikira Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Advisory Committee Member relationship with Medimmune Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Contracted Research relationship with Maven Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Contracted Research relationship with Evelobio Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Contracted Research relationship with Johnson & Johnson Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Advisory Committee Member relationship with AstraZeneca; RIFM; Equillium; Genentech; Thervance Please note: 24 months by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Consultant relationship with AstraZeneca; RIFM; Equillium; Bayer Please note: 24 months by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Speaker/Speaker's Bureau relationship with AstraZeneca; Sanofi/Regeneron; Genentech Please note: 24 months by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Research grant recipient relationship with Novartis; Optikira; Medimmune; Maven; Evelobio Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Research grant recipient relationship with Johnson & Johnson; AstraZeneca; RIFM; Equillium; Genentech Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Research grant recipient relationship with Theravance Please note: 24 months by Reynold Panettieri, value=Grant/Research Support Advisory Committee Member relationship with AstraZeneca Please note: $1001 - $5000 by Reynold Panettieri, value=Consulting fee Removed 03/29/2022 by Reynold Panettieri Principal Investigator relationship with AstraZeneca Please note: $20001 - $100000 by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Speaker/Speaker's Bureau relationship with AstraZeneca Please note: $1001 - $5000 by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Advisory Committee Member relationship with MedImmune Please note: $1001 - $5000 by Reynold Panettieri, value=Consulting fee Removed 03/29/2022 by Reynold Panettieri Principal Investigator relationship with MedImmune Please note: $20001 - $100000 by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Advisory Committee Member relationship with Reseaerch Institute for Fragrance Materials Please note: $1001 - $5000 by Reynold Panettieri, value=Consulting fee Removed 03/29/2022 by Reynold Panettieri Principal Investigator relationship with Reseaerch Institute for Fragrance Materials Please note: $20001 - $100000 by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Advisory Committee Member relationship with Equillium Please note: $1001 - $5000 by Reynold Panettieri, value=Consulting fee Removed 03/29/2022 by Reynold Panettieri Principal Investigator relationship with Equillium Please note: $20001 - $100000 by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Advisory Committee Member relationship with Theravance Please note: $1001 - $5000 by Reynold Panettieri, value=Consulting fee Removed 03/29/2022 by Reynold Panettieri Advisory Committee Member relationship with Avillion Please note: $1001 - $5000 by Reynold Panettieri, value=Consulting fee Speaker/Speaker's Bureau relationship with Sanofi/Regeneron Please note: $1001 - $5000 by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Speaker/Speaker's Bureau relationship with Genentech Please note: $1001 - $5000 by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Principal Investigator relationship with Genentech Please note: $20001 - $100000 by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Principal Investigator relationship with OncoArendi Please note: $20001 - $100000 by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with Metera Please note: $20001 - $100000 by Reynold Panettieri, value=Grant/Research Support Removed 03/29/2022 by Reynold Panettieri Consultant relationship with TEVA Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Honoraria Removed 03/29/2022 by Reynold Panettieri Consultant relationship with AstraZeneca Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Honoraria Advisory Committee Member relationship with AstraZeneca Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Honoraria Speaker/Speaker's Bureau relationship with AstraZeneca Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Honoraria Principal Investigator relationship with AstraZeneca Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Consultant relationship with RIFM Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Honoraria Advisory Committee Member relationship with RIFM Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Honoraria Principal Investigator relationship with RIFM Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Advisory Committee Member relationship with Genentech Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Honoraria Principal Investigator relationship with Genentech Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Consultant relationship with TEVA Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Honoraria Principal Investigator relationship with TEVA Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with Equillium Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with Novartis Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with Medimmune Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with Origo Please note: 24 months Added 03/29/2022 by Reynold Panettieri, value=Grant/Research Support Principal Investigator relationship with ACTIV-1 Please note: 24 months Added 03/29/2022 by 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Elpen Pharmaceuticals Please note: 2019 by Alberto Papi, value=Travel Speaker/Speaker's Bureau relationship with Edmondpharma Please note: 2020 by Alberto Papi, value=Honoraria Speaker/Speaker's Bureau relationship with AZ, GSK, Chiesi, Novartis, BI, Sanofi, Zambon, Mundipharma Please note: Present Added 04/04/2022 by Alberto Papi, value=Honoraria Grant relationship with Boehringer Ingelheim, Sanofi, AZ, GSK Please note: Present Added 04/04/2022 by Alberto Papi, value=Grant/Research Support No relevant relationships by Robert Rees Shareholder relationship with AstraZeneca Please note: >5 years by Frank Trudo, value=Shares Employee Consultant relationship with AbbVie Please note: Oct 2021 to Feb 2022 Added 04/04/2022 by Mark Weinberg, value=Consulting fee