IntroductionPleural effusions are known to occur in many cases of COVID-19. Data on typical characteristics of COVID-19-associated pleural effusions are limited. The goal of this project was to characterize the pleural fluid from patients with COVID-19.MethodsWe retrospectively collected electronic medical record data from adults hospitalized at a large metropolitan hospital system with COVID-19 infection who had a pleural effusion and a thoracentesis performed. We assessed pleural fluid characteristics and applied Light's criteria.ResultsWe identified 128 effusions from 106 unique patients; 45.4% of the effusions had fluid/serum protein ratio greater than 0.5, 33.9% had fluid/serum lactate dehydrogenase (LDH) greater than 0.6, and 56.2% had fluid LDH greater than 2/3 of the serum upper limit of normal. Altogether, 68.5% of effusions met at least one of these three characteristics and therefore were exudative by Light's criteria. The white blood cell (WBC) differential was predominantly lymphocytic (mean 42.8%) or neutrophilic (mean 28.7%); monocytes (mean 12.7%) and eosinophils (mean 2.5%) were less common.ConclusionWe demonstrate that 68.5% of pleural effusions in patients with COVID-19 infection were exudative and hypothesize that COVID-19-associated pleural effusions are likely to be exudative with WBC differential more likely to be predominantly lymphocytic. The pleural fluid characteristics associated with COVID-19 infection were assessed in 128 effusions from 106 unique patients; 68.5% of effusions met at least one of the three Light's criteria and therefore were exudative. Elevated LDH was notable. The white blood cell differential was predominantly lymphocytic (in 60.9% of effusions) or neutrophilic (30.5%). image

Background: Clinician-patient miscommunication contributes to worse asthma outcomes. What patients call their asthma inhalers and its relationship with asthma morbidity are unknown. Methods: Inhaler names were ascertained from Black and Latinx adults with moderate-severe asthma and categorized as “standard” if based on brand/generic name or inhaler type (i.e., controller vs. rescue) or “non-standard” for other terms (i.e., color, device type, e.g., “puffer,” or unique names). Clinical characteristics and asthma morbidity measures were evaluated at baseline: self-reported asthma exacerbations one year before enrollment (i.e., systemic corticosteroid bursts, emergency department (ED)/urgent care (UC) visits, or hospitalizations), and asthma control and quality of life. Multivariable regression models tested the relationship between non-standard names and asthma morbidity measures, with adjustments. Results: Forty-four percent (502/1150) of participants used non-standard inhaler names. These participants were more likely to be Black (p=0.006), from the Southeast (p<0.001), and have fewer years with asthma (p=0.012) relative to those who used standard names. Non-standard inhaler names was associated with an incidence rate ratio (IRR) of 1.29 (95% confidence interval [CI], 1.11-1.50, p=0.001; 1.8 vs. 1.5 events) for corticosteroid bursts for asthma, an IRR=1.43 (95% CI, 1.21-1.69, p<0.001; 1.9 vs. 1.4 events) for ED/UC visits for asthma, and an odds ratio=1.57 (95% CI, 1.12-2.18, p=0.008; 0.5 vs. 0.3 events) for asthma hospitalizations after adjustment. Conclusions: Patients who use non-standard names for asthma inhalers experience increased asthma morbidity. Ascertaining what patients call their inhalers may be a quick method to identify those at higher risk of poor outcomes.

Background: Hispanic/Latinx (HL) ethnicity encompasses racially and culturally diverse subgroups. Studies suggest that Puerto Ricans (PR) may bear greater asthma-related morbidity than Mexicans, but these were conducted in children or had limited clinical characterization. Objectives: This study sought to determine whether disparities in asthma morbidity exist among HL adult subgroups. Methods: Adults with moderate-severe asthma were recruited from US clinics, including from Puerto Rico, for the Person Empowered Asthma Relief (PREPARE) trial. Considering the shared heritage between PR and other Caribbean HL (Cubans and Dominicans [C&D]), the investigators compared baseline self-reported clinical characteristics between Caribbean HL (CHL) (PR and C&D: n = 457) and other HLs (OHL) (Mexicans, Spaniards, Central/South Americans; n = 141), and between CHL subgroups (C&D [n = 56] and PR [n = 401]). This study compared asthma morbidity measures (self-reported exacerbations requiring systemic corticosteroids, emergency department/urgent care (ED/UC) visits, hospitalizations, health care utilization) through negative binomial regression. Results: CHL compared to OHL were similar in age, body mass index, poverty status, blood eosinophils, and fractional exhaled nitric oxide but were prescribed more asthma controller therapies. Relative to OHL, CHL had significantly increased odds of asthma exacerbations (odds ratio [OR]: 1.84; 95% CI: 1.4-2.4), ED/UC visits (OR: 1.88; 95% CI: 1.4-2.5), hospitalization (OR: 1.98; 95% CI: 1.06-3.7), and health care utilization (OR: 1.91; 95% CI: 1.44-2.53). Of the CHL subgroups, PR had significantly increased odds of asthma exacerbations, ED/UC visits, hospitalizations, and health care utilization compared to OHL, whereas C&D only had increased odds of exacerbations compared to OHL. PR compared to C&D had greater odds of ED/UC and health care utilization. Conclusions: CHL adults, compared with OHL, adults reported nearly twice the asthma morbidity; these differences are primarily driven by PR. Novel interventions are needed to reduce morbidity in this highly impacted population.

Patients frequently use non-standard terms for asthma inhalers. Such use is easy to determine. Whether such terms are associated with clinically important patient characteristics is unknown. African-American/Black and Hispanic/Latinx adults with moderate-severe asthma were recruited from U.S. clinics for the ongoing PeRson EmPowered Asthma RElief (PREPARE) trial. Preferred terms for asthma controller and reliever inhalers were collected from 1,150 participants for reference in monthly trial surveys. Terms based on brand name or inhaler type (i.e., "reliever ") were categorized as "standard." Other terms (e.g., color, device type) were categorized as "non-standard." Clinical characteristics were compared by inhaler term category using Chi-square and student's t-tests. Adjudicated asthma outcomes included self-reported asthma exacerbations (utilizing oral/parenteral corticosteroids) in the year prior to enrollment, emergency department (ED)/urgent care (UC) visits, or hospitalizations. Multivariable regression models were adjusted by health literacy, language, race/ethnicity, education, region, age, gender, and BMI. Forty-four percent of participants used non-standard terms, which associated with an odds ratio (OR) of 1.30 (95% CI 1.04-1.62, p=0.020) of exacerbations, 1.38 OR (95% CI 1.11-1.73, p=0.004) of ED/UC visits, and 1.50 OR (95% CI 1.10-2.06, p=0.010) of hospitalizations compared to standard term use when adjusted for all the factors above. Patients who use non-standard terms for asthma inhalers are at greater odds of poor asthma outcomes independent of primary language, education, and health literacy. Asking patients to name their medications may allow caregivers to identify those at greater risk for poor asthma outcomes.

Purpose:To describe the socioeconomic and healthcare-related effects of the COVID-19 pandemic, and willingness to receive a free COVID-19 vaccine, among African American/Black (AA/B) and Hispanic/Latinx (H/L) adults with asthma currently enrolled in a large trial. Methods:The present analysis is a sub-study of the PeRson EmPowered Asthma RElief (PREPARE) study, a pragmatic study of 1201 AA/B and H/L adults with asthma. A monthly questionnaire was completed by a subset of PREPARE participants (n =325) during May-August, 2020. The 5-item questionnaire assessed self-reported Impact of COVID-19 on respondents' ability to obtain asthma medications. medical care quality, employment, income and ability to pay bits; and willingness to get a free COVID-19 vaccine. Bivariate analysis and multivariate logistic regression were performed to investigate factors associated with vaccine hesitancy. Results:Of 325 survey respondents (25% AA/8, 75% H/L), the majority reported no impact of COVID-19 on medical care or ability to get asthma medications. Approximately half of employed respondents experienced a tower levet of employment or job loss. and approximately half reported having difficulty paying bills during the pandemic. Thirty-five percent of respondents reported unwillingness and 31% reported being somewhat likely to receive a free COVID-19 vaccine. AA/8 race/ethnicity and poorer reported physical health were associated with a higher likelihood of COVID-19 vaccine hesitancy. Conclusion:AA/B and H/L adults with asthma may experience changes in the quality of their asthma care and increased socioeconomic stressors as a result of the COVID-19 pandemic and may be hesitant or unwilling to receive a COVID-19 vaccine.

BACKGROUND:Asthma disproportionately affects African American/Black (AA/B) and Hispanic/Latinx (H/L) patients and individuals with low socioeconomic status (SES), but the relationship between SES and asthma morbidity within these racial/ethnic groups is inadequately understood. OBJECTIVE:To determine the relationship between SES and asthma morbidity among AA/B and H/L adults with moderate to severe asthma using multidomain SES frameworks and mediation analyses. METHODS:We analyzed enrollment data from the PeRson EmPowered Asthma RElief randomized trial, evaluating inhaled corticosteroid supplementation to rescue therapy. We tested for direct and indirect relationships between SES and asthma morbidity using structural equation models. For SES, we used a latent variable defined by poverty, education, and unemployment. For asthma morbidity, we used self-reported asthma exacerbations in the year before enrollment (corticosteroid bursts, emergency room/urgent care visits, or hospitalizations), and Asthma Control Test scores. We tested for mediation via health literacy, perceived stress, and self-reported discrimination. All models adjusted for age, sex, body mass index, ethnicity, and comorbidities. RESULTS:Among 990 AA/B and H/L adults, low SES (latent variable) was directly associated with hospitalizations (β = 0.24) and worse Asthma Control Test scores (β = 0.20). Stress partially mediated the relationship between SES and increased emergency room/urgent care visits and worse asthma control (β = 0.03 and = 0.05, respectively). Individual SES domains were directly associated with asthma morbidity. Stress mediated indirect associations between low educational attainment and unemployment with worse asthma control (β = 0.05 and = 0.06, respectively). CONCLUSIONS:Lower SES is directly, and indirectly through stress, associated with asthma morbidity among AA/B and H/L adults. Identification of stressors and relevant management strategies may lessen asthma-related morbidity among these populations.

Efforts to reduce the disproportionate asthma morbidity in African American/Black (AA/B) and Hispanic/Latinx (H/L) patients have been mostly unsuccessful. In a pragmatic, randomized study, we tested a Patient-Activated Reliever-Triggered Inhaled Corticosteroid (ICS) Strategy (PARTICS) in 1201 AA/B and H/L patients with moderate-to-severe asthma. PREPARE compared the addition of PARTICS [concomitant use of study-provided ICS (beclomethasone dipropionate 80 mcg) with reliever] to usual care (UC) (PARTICS+UC) with UC in 603 AA/B and 598 H/L adults (18–75 years old) who had an Asthma Control Test (ACT) <20 or an exacerbation in the past year (NCT02995733). UC continued at physician discretion. The primary endpoint was verified severe asthma exacerbations. Patients had one instructional visit followed by 15 monthly questionnaires. PARTICS+UC reduced severe asthma exacerbations by 15.4% (p=0.048) which corresponded to a reduction of 13 exacerbations/100 patient-years. PARTICS+UC improved ACT scores by 3.37 vs. 2.53 points from baseline (p<0.0001). ACT scores improved by ≥3 points from baseline during 11.8% more study months for patients assigned to PARTICS+UC versus UC (p=0.006). Asthma Symptom Utility Index (ASUI) scores improved by 0.12 versus 0.08 points (p<0.0001). The annualized rate of days missed of work/school/usual activities was reduced by 3.33 days/year (p=0.013). The total additional ICS use in PARTICS+UC was 1.3 refills/year. A patient-centered, one-time instruction in PARTICS, resulting in minimal additional ICS use, substantially reduces asthma exacerbations and improves asthma control and quality of life in AA/B and H/L adults with poorly controlled asthma.

BACKGROUND Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. METHODS In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 μg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed. RESULTS Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups. CONCLUSIONS Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

Although bilateral lung volume reduction surgery has been shown to be safe and effective in carefully selected patients with upper lobe-predominant emphysema and hyperinflation, bronchoscopic lung volume reduction via placement of endobronchial valves is conventionally performed only unilaterally. Furthermore, it is not offered to patients with interlobar collateral ventilation because of the lack of clinical efficacy. We describe two novel management approaches including (1) bilateral bronchoscopic lung volume reduction, and (2) a combined thoracic surgical and interventional pulmonary procedure involving surgical fissure completion followed by endobronchial valve placement, which culminated in safe and effective lung volume reduction of both lungs along with an excellent patient outcome.

Background: Spirometry with bronchodilator testing (BDT) is used routinely in the diagnosis and clinical phenotyping of obstructive lung diseases.Previous reports (1) have demonstrated that individuals with FEV 1 > 90% predicted are unlikely (0 -1.9%) to meet ATS/ERS criteria (2) for bronchodilator response (BDR) and suggest that BDT is not clinically useful in such patients.However, that study was performed in patients with all types of suspected lung disease and we examined whether criteria to limit BDT using baseline FEV 1 would be applicable in patients with self-reported asthma.Methods: A retrospective observational study of adult patients with self-reported asthma at a single center in Boston, MA between 1997 and 2020.Spirometry testing was performed in accordance with ATS guidelines for acceptability and repeatability on subjects in the seated position using nose clips and all subjects were given a total of 360μg of albuterol in 4 separate doses and spirometry was repeated 15-30 minutes later.All subjects withheld underlying medications as per ATS guidelines.We grouped BDR by decile of predicted FEV 1 .We used the Mantel-Haenszel Chi-square test to assess the significance of reversibility across decile of FEV 1 .Results: A total of 1,941 individuals with complete pre-and post-bronchodilator data were analyzed.The mean age was 38 ± 14.5 and 66% (n = 1276) were female.The mean baseline FEV 1 was 80% + 24.A total of 535 (28%) showed a positive BDR, and overall men were more likely to have a positive BDR (33% vs 25% for men and women, respectively; p < 0.001).There was a stepwise decrease in the frequency of reversibility with increasing decile of baseline predicted FEV 1 (p < 0.001; Figure 1).All subjects (n = 8) with a BDR and baseline FEV 1 > 100% predicted were female (p = 0.2).There were no significant differences in the frequency of reversibility for individuals with as needed reliever or asthma controller therapies (all p > 0.05).Discussion: Whereas previous studies have suggested that BDT in patients with an FEV 1 > 90% predicted might not be clinically useful, we found that 15% of patients with an FEV 1 > 90% with a self-report of asthma demonstrated BDR.Men are overall more likely to have reversibility compared to women.There was no relationship between asthma controller therapy and probability of reversibility.These data suggest that BDT may still be useful in confirming asthma even in patients with high baseline FEV 1 .

PURPOSE: Asthma disproportionately affect African American/Black (AA/B) and Hispanic/Latinx (H/L) individuals; but the extent to which socioeconomic status (SES) affects asthma morbidity within these racial/ethnic groups is limited.Our purpose was to determine whether SES associates with asthma morbidity measures among AA/B and H/L. METHODS:The PCORI-funded PeRson EmPowered Asthma RElief (PREPARE) study is a randomized, open-label, pragmatic clinical trial of AA/B and H/L adults with moderate to severe asthma.This ancillary study analyzed data collected at trial enrollment (n¼1201) to assess associations between SES and morbidity measures (self-reported steroid bursts, emergency room (ER) visits, hospitalization, and asthma control scores).Structural equation models were fit to test direct and indirect effects of SES on six different asthma morbidity measures.Indirect relationships between asthma and morbidity were tested via health literacy, stress, and discrimination scores.All models were adjusted by age, gender, body mass index, race/ethnicity, and medical comorbidity count.RESULTS: SES was found to have a direct positive association with asthma hospitalizations and worse asthma control scores.Stress was a mediator between SES and several outcomes (ER visits, and asthma control scores), with lower SES (lower income, unemployment, and less education) correlating with higher stress and worse asthma morbidity measures.Health literacy and discrimination did not mediate any associations between SES and asthma morbidity measures; however, a direct effect of discrimination on steroid bursts and APGAR scores was observed.CONCLUSIONS: Lower SES is directly associated with more asthma hospitalizations and worse asthma control in AA/B and H/L patients.Stress partially mediates the association between SES and morbidity measures, with more significant stress leading to more ER visits and worse asthma symptoms scores.CLINICAL IMPLICATIONS: Lower SES is directly associated with more severe asthma morbidity outcomes, an effect partially mediated by stress.

TOPIC: Allergy and Airway TYPE: Original Investigations PURPOSE: Hispanic/Latinx (HL) ethnicity incorporates many subgroups from diverse racial and cultural backgrounds. Studies suggest that Puerto Ricans (PR) have a greater asthma prevalence and asthma-related morbidity relative to White and Mexican counterparts. However, these studies were in children or limited in clinical and phenotypic characterization. Our purpose was to determine whether clinical, phenotypic differences, and disparities in asthma-related morbidity exist across adult HL subgroups. Considering the shared heritage between PR and other Caribbean HL (Cubans and Dominicans, C&D), we hypothesized that Caribbean HL (CHL; PR and C&D) adults would have greater asthma morbidity compared to other HLs (OHL; Mexicans, Spaniards, Central/South Americans). METHODS: Adults with moderate-severe persistent asthma were recruited from primary care/specialty clinics across the United States, including Puerto Rico, for the PREPARE trial, an open-label pragmatic trial testing a patient directed treatment strategy compared to usual care in Black and HL adults. We examined baseline differences in self-reported clinical characteristics between CHL (n= 457) and OHL (n=141) and between CHL subgroups C&D (n=56) and PR (n=401). These were evaluated through Chi-square or t-tests. Differences in asthma morbidity measures (self-reported exacerbations requiring steroids, ER visits, hospitalizations) were tested with multivariate logistic and ordinal regression models, with adjustment for age, gender, BMI, controller therapy and poverty measure. RESULTS: CHL compared to OHL were more likely to be female (84% vs 77% p=0.04) and to be prescribed more asthma controller therapies (ICS + >2 controllers 50% vs 22% p<0.001) but were similar in age (48 vs 46 years p=0.16), BMI (33 vs 32 p=0.18), poverty measure (46% vs 43% p=0.14), blood eosinophils (263 vs 290 p=0.37) and FeNO (27 vs 31 ppb p=0.2). Relative to OHL, CHL had 7.9-fold greater odds of more asthma exacerbations (95%CI 2.4 to 26.6-fold greater p<0.001), 10.3-fold greater odds of more ER visits (95%CI 3.1 to 34.1-fold greater p<0.001), and trended towards greater odds of hospitalizations (OR=5.4 p=0.08). While PR (n=401) exhibited similar morbidity measures relative to OHL, C&D (n=56) had greater odds of exacerbations than OHL (2.0, 95% 1.1 to 3.5-fold greater p=0.03) but not ER visits or hospitalizations. PR had greater odds of more ER visits than C&D but not exacerbations overall. CONCLUSIONS: CHL adults exhibit increased asthma morbidity relative to OHL. While both PR and C&D have more asthma exacerbations relative to OHL, PR have greater odds of ER visits relative to C&D. Geography, healthcare access, ancestry and culture may underlie these differences. CLINICAL IMPLICATIONS: Adult CHL have worse asthma morbidity relative to OHL. Further research is needed to understand and find interventions to address this disparity. 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BACKGROUND:Generally, a short-acting beta-2 agonist (SABA) delivered via metered-dose inhaler (MDI) is recommended for quick relief of asthma symptoms. However, in the PeRson EmPowered Asthma RElief (PREPARE) pragmatic trial, 67% of patients reported having used a nebulizer for SABA administration. OBJECTIVE:To understand preferences, experiences, and decision making regarding the use of nebulizers in Black and Latinx adults with uncontrolled asthma. METHODS:We interviewed 40 of the 1,201 PREPARE patients employing a matrix analysis. Those interviewed were Black (n = 20) and Latinx (n = 20) adults with uncontrolled asthma seeking primary or specialty care in clinics throughout the United States. Data were analyzed used a Rapid Assessment Procedures qualitative methodology, informed by grounded theory. RESULTS:Substudy participants, on average, reported using a nebulizer 3.5 times/wk. Daily use was common, and frequency ranged from less than daily to up to 6 times daily. Nearly all participants reported a longstanding history of nebulizer use. Participants tended to use their nebulizer at home, and some shared it with others in the home. Many reported preferring a nebulizer over an MDI for relief of severe symptoms and to avoid emergency room visits or hospitalizations. The extent to which cost affected nebulizer use varied among participants. CONCLUSIONS:Despite asthma guideline recommendations that MDIs be used rather than nebulizers for SABA administration, nebulizer use was common among PREPARE study participants. Clinicians should explore patients' history and experiences with nebulizer use as part of evaluation of asthma control.

BACKGROUND:Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown. OBJECTIVE:We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols. METHODS:Four sites recruited 33 Hispanic or black adults with persistent asthma, randomized them approximately 3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved 1 randomization visit and monthly questionnaires. Timely questionnaire responses (±2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures. RESULTS:Timely questionnaire response rates were 61%, 64%, and 70% at 4, 8, and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% (95% confidence interval [CI], 58%-94% [n = 21]), 88% (95%CI, 72%-100% [n = 16]), and 62% (95%CI, 36%-88% [n = 13]) at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as "reliever" or "rescue." CONCLUSION:Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures. CLINICAL TRIALS REGISTRATION:pilot study for 'PeRson EmPowered Asthma Relief' (PREPARE, NCT02995733).

BACKGROUND:Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality.