Occupational exposures among women beedi workers in Mysore District, India: A mixed-methods study protocol.

Beedi is the most common smoking form of tobacco used in India. The rolling of beedis is performed primarily by women in settings that lack occupational safeguards. The aims of this protocol are to establish methods for the study of occupational exposures among women beedi workers and their experiences and challenges working with unburnt tobacco. This protocol employs a convergent parallel mixed-methods approach. Qualitatively, we plan to explore the experiences and challenges faced by women beedi workers using photovoice, a community based participatory method. Occupational exposures to pesticides will be assessed through the use of silicone wristbands worn for seven days by workers, and exposure to toxic metals and metalloids will be assessed in dust samples collected in the homes of workers. The outcomes will be analyzed to form policy recommendations to improve the occupational health of women beedi workers.

School Connectedness and Suicide Among High School Youth: A Systematic Review.

BACKGROUND: Suicide is a leading cause of death for adolescents, and school connectedness is a potential, modifiable protective factor for suicide. We sought to examine if school connectedness protected against suicide among high school students and if potential moderators affected the relationship between school connectedness and suicide. METHODS: We searched online databases (PubMed, EMBASE, CINAHL, and PsycINFO) on December 12, 2021, for studies that examined the effects of school connectedness on suicide among high school students. RESULTS: This systematic review identified 34 studies that examined the effects of school connectedness on adolescent suicidality. Results indicated mixed findings of school connectedness on suicidality. Among studies that assessed a suicide ideation outcome, 73.3% found that school connectedness protected against suicide. Among studies that assessed a suicide attempts outcome, 50% found that school connectedness protected against suicide. Most included studies did not control for notable variables in their final models, such as sleep, impulsivity, substance use, or depression. No studies examined moderators of school connectedness and suicide. CONCLUSIONS: School connectedness is somewhat protective of suicidality, and more protective of suicidal ideation than suicide attempts. Researchers should examine the construct of school connectedness among modern youth to better understand school connectedness and suicide.

Recruitment strategies in marginalized industries for occupational health research: an example in a pilot study of cleaning staff during COVID-19.

This commentary describes challenges in recruiting workers from marginalized industries with examples from a pilot study of janitors, custodians, and maids and their experiences of cleaning and disinfection protocols during COVID-19 and potentially associated respiratory symptoms. Recruitment strategies included contacting a local hospital, national workers' unions, and a large Arizona employer; using online Facebook groups; and contacting Arizona maid service companies and a school district. English and Spanish online and hard copy surveys about cleaning protocols and respiratory symptoms were used. Participants could also participate in online/phone interviews. Worker's compensation, liability, and confidentiality were concerns across organizations. Online surveys yielded unreliable data. Hard copy surveys were used due to workers' limited technology access. We reflect upon these challenges and discuss other strategies for recruiting from marginalized populations for occupational health research. Building trust with organizations and workers and considering technology access may ultimately increase recruitment feasibility.

Home Oxygen After Hospitalization for COVID-19: Results From the Multi-Center OXFORD Study.

BACKGROUND: In the first months of the pandemic, prior to the introduction of proven-effective treatments, 15-37% of patients hospitalized with COVID-19 were discharged on home oxygen. After proven-effective treatments for acute COVID-19 were established by evidence-based guidelines, little remains known about home oxygen requirements following hospitalization for COVID-19. METHODS: This was a retrospective, multi-center cohort study of subjects hospitalized for COVID-19 between October 2020-September 2021 at 3 academic health centers. Information was abstracted from electronic health records at the index hospitalization and for 60 d after discharge. The World Health Organization COVID-19 Clinical Progression Scale score was used to identify patients with severe COVID-19. RESULTS: Of 517 subjects (mean age 58 y, 47% female, 42% Black, 36% Hispanic, 22% with severe COVID-19), 81% were treated with systemic corticosteroids, 61% with remdesivir, and 2.5% with tocilizumab. About one quarter of subjects were discharged on home oxygen (26% [95% CI 22-29]). Older age (adjusted odds ratio [aOR] 1.02 per 5 y [95% CI 1.02-1.02]), higher body mass index (aOR 1.02 per kg/m2 [1.00-1.04]), diabetes (yes vs no, aOR 1.73 [1.46-2.02]), severe COVID-19 (vs moderate, aOR 3.19 [2.19-4.64]), and treatment with systemic corticosteroids (yes vs no, aOR 30.63 [4.51-208.17]) were associated with an increased odds of discharge on home oxygen. Comorbid hypertension (yes vs no, aOR 0.71 [0.66-0.77) was associated with a decreased odds of home oxygen. Within 60 d of hospital discharge, 50% had documentation of pulse oximetry; in this group, home oxygen was discontinued in 46%. CONCLUSIONS: About one in 41 subjects were prescribed home oxygen after hospitalization for COVID-19, even after guidelines established proven-effective treatments for acute illness. Evidence-based strategies to reduce the requirement for home oxygen in patients hospitalized for COVID-19 are needed.

COVID-19 cleaning protocol changes, experiences, and respiratory symptom prevalence among cleaning services personnel.

Introduction: Cleaning protocols were changed in response to the COVID-19 pandemic with unknown occupational health impacts. There is evidence that COVID-19 transmission risks from contaminated surfaces are low and that exposure to cleaning products can increase risks of work-related asthma. The study objective was to investigate relationships between reported COVID-19-related changes in cleaning protocols and prevalence of asthma-related respiratory symptoms for asthmatic and non-asthmatic janitors and maids. A secondary objective was to characterize experiences of respiratory symptoms associated with cleaning and barriers to personal protective equipment (PPE) use. Methods: Employees from two Tucson-based maid service companies (approximately 30 personnel in total) and one Phoenix-based school district (>300 janitors/custodians) were invited to participate in a written survey and/or a one-on-one interview in Spanish or English. Fisher's exact tests (α = 0.05) were used to test for statistically significant associations between reported respiratory symptoms by self-reported physician-diagnosed asthma status and changes in cleaning protocols. Interviews were transcribed and then analyzed by at least two researchers in English or Spanish. Results: Eighty-three percent reported that cleaning protocols had changed during COVID-19, with the two most reported changes including increased cleaning frequency (92%) and change of application type (e.g., fog, spray, wipe) (53%). There was a statistically significant association between multiple respiratory symptoms and self-reported physician diagnosed asthma. Reporting a type of application change (e.g., fog, spray, wipe) and being awakened during the night by attack/episode of cough were statistically significantly associated (p = 0.04). Interviews elucidated respiratory issues related to fogging devices. Discussion: This study provides preliminary evidence that changes in cleaning and disinfection protocols during COVID-19 (namely, the use of fogging/mechanical spraying devices) may have had negative impacts on the health of workers in the cleaning industry with little benefit to reducing COVID-19 risks. Further research is needed to evaluate the generalizability of our findings across larger geographical areas and to develop guidance for employers and employees on how to protect and promote respiratory health.

A Hybrid Effectiveness/Implementation Clinical Trial of Adherence to Long-Term Oxygen Therapy for Chronic Obstructive Pulmonary Disease.

Rationale: Interventions to promote adherence to long-term oxygen therapy (LTOT) in chronic obstructive pulmonary disease (COPD) are needed. Objectives: To examine the real-world effectiveness of phone-based peer coaching on LTOT adherence and other outcomes in a pragmatic trial of patients with COPD. Methods: In a hybrid effectiveness/implementation pragmatic trial, patients were randomized to receive phone-based proactive coaching (educational materials, five phone-based peer coaching sessions over 60 d), reactive coaching (educational materials, peer coaching when requested), or usual care. Study staff members collected baseline and outcome data via phone at 30, 60, and 90 days after randomization. Adherence to LTOT over 60 days, the primary effectiveness outcome, was defined as mean LTOT use ⩾17.7 h/d. LTOT use was calculated using information about home oxygen equipment use in worksheets completed by study participants. Comparisons of adherence to LTOT between each coaching group and the usual care group using multivariable logistic regression models were prespecified as the primary analyses. Secondary effectiveness outcomes included Patient Reported Outcome Management Information System measures for physical, emotional, and social health. We assessed early implementation domains in the reach, adoption, and implementation framework. Results: In 444 participants, the proportions who were adherent to LTOT at 60 days were 74% in usual care, 84% in reactive coaching, and 70% in proactive coaching groups. Although reach, adoption by stakeholder partners, and intervention fidelity were acceptable, complete LTOT adherence data were available in only 73% of participants. Reactive coaching (adjusted odds ratio, 1.77; 97.5% confidence interval, 0.80-3.90) and proactive coaching (adjusted odds ratio, 0.70; 97.5% confidence interval, 0.34-1.46) did not improve adherence to LTOT compared with usual care. However, proactive coaching significantly reduced depressive symptoms and sleep disturbance compared with usual care and reduced depressive symptoms compared with reactive coaching. Unexpectedly, LTOT adherence was significantly lower in the proactive compared with the reactive coaching group. Conclusions: The results were inconclusive about whether a phone-based peer coaching strategy changed LTOT adherence compared with usual care. Further studies are needed to confirm the potential benefits of proactive peer coaching on secondary effectiveness outcomes and differences in LTOT adherence between proactive and reactive peer coaching. Clinical trial registered with ClinicalTrials.gov (NCT02098369).

School health systems under strain: an example of COVID-19 experiences & burnout among school health staff in Pima County, Arizona.

BACKGROUND: School health staff lead and provide a variety of care for children in schools. As school districts have navigated the COVID-19 pandemic, school health staff have faced unprecedented challenges in protecting the health of students and school staff. Our objective was to qualitatively characterize these pandemic challenges and experiences of school health staff in Pima County, Arizona to identify gaps in school health staff support for improving future emergency preparedness. METHODS: We conducted two focus group discussions (FGDs) with 48 school health staff in Pima County, Arizona in two school districts using a discussion guide including ten open-ended questions. The FGDs were audio recorded and transcribed verbatim. We used the socioecological model (SEM) to organize the thematic analysis and generate codes and themes; data were analyzed using Atlas.ti software. FINDINGS: The pandemic has significantly challenged school health staff with new pandemic-related job tasks: managing isolation, vaccination, and developing/implementing new and evolving COVID-19 guidelines. School health staff also reported increased stress related to interactions with parents and school administration as well as frustrations with rapid changes to guidance from the health department and policy makers. A common issue was not having enough staff or resources to complete regular job responsibilities, such as providing care for students with non-COVID-19 related health issues. CONCLUSIONS: Increased workload for school health staff resulted in physical burnout, mental distress, and disruption of core functions with long term implications for children's health. These focus groups highlight the need for improved emergency preparedness in schools during pandemics or infectious disease outbreaks. These include basic infrastructure changes (e.g., personnel support from health departments for tasks such as contact tracing to enable school nurses to continue core functions), and increased funding to allow for hazard pay and more school health personnel during emergency situations. In addition, basic school health infrastructure is lacking, and we should include a licensed school health nurse in every school.

Coordinated Health Care Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) plan.

Background: Evidence-based strategies to improve outcomes in minority children with uncontrolled asthma discharged from the emergency department (ED) are needed. Objectives: This multicenter pragmatic clinical trial was designed to compare an ED-only intervention (decision support tool), an ED-only intervention and home visits by community health workers for 6 months (ED-plus-home), and enhanced usual care (UC). Methods: Children aged 5 to 11 years with uncontrolled asthma were enrolled. The change over 6 months in the Patient-Reported Outcomes Measurement Information System Asthma Impact Scale score in children and Satisfaction with Participation in Social Roles score in caregivers were the primary outcomes. The secondary outcomes included guideline-recommended ED discharge care and self-management. Results: Recruitment was significantly lower than expected (373 vs 640 expected). Of the 373 children (64% Black and 31% Latino children), only 63% completed the 6-month follow-up visit. In multivariable analyses that accounted for missing data, the adjusted odds ratios and 98% CIs for differences in Asthma Impact Scores or caregivers' Satisfaction with Participation in Social Roles scores were not significant. However, guideline-recommended ED discharge care was significantly improved in the intervention groups versus in the UC group, and self-management behaviors were significantly improved in the ED-plus-home group versus in the ED-only and UC groups. Conclusions: The ED-based interventions did not significantly improve the primary clinical outcomes, although the study was likely underpowered. Although guideline-recommended ED discharge care and self-management did improve, their effect on clinical outcomes needs further study.

Clinical Practices Surrounding the Prescription of Home Oxygen in Patients With COPD and Desaturation.

Purpose: While home oxygen therapy increases survival in patients with chronic obstructive pulmonary disease (COPD) who have severe resting hypoxemia, recent evidence suggests that there is no survival benefit of home oxygen for patients with COPD who have isolated exertional desaturation. We aimed to understand clinician practice patterns surrounding the prescription of home oxygen for patients with COPD. Methods: We conducted semi-structured qualitative interviews via videoconference with 15 physicians and 3 nurse practitioners who provide care for patients with COPD. Clinicians were recruited through the American Lung Association Airways Clinical Research Centers. Interview guides were created with the assistance of patient investigators and included questions regarding clinician practices surrounding the prescription of oxygen for patients with COPD and the use of clinical guidelines. Interviews were recorded, transcribed, and coded for themes. Results: Of the 18 clinician interviewees, one-third were women, with most participants (n=11) being < 50 years old. Results of the semi-structured interviews suggested research evidence, clinical experience, and patient preferences contributed to clinician decision-making. Most clinicians described a shared decision-making process for prescribing home oxygen for patients, including discussion of risks and benefits, and developing an understanding of patient values and preferences. Clinicians did not use a structured tool to conduct these conversations. Conclusions: Clinicians consider a number of patient and clinical factors when prescribing home oxygen therapy, often using a shared decision-making process. Tools to support shared decision-making about the use of home oxygen are needed.

Exposure frequency, intensity, and duration: What we know about work-related asthma risks for healthcare workers from cleaning and disinfection.

The objective of this review was to scope the current evidence base related to three exposure assessment concepts: frequency, intensity, and duration (latency) for cleaning and disinfection exposures in healthcare and subsequent work-related asthma risks. A search strategy was developed addressing intersections of four main concepts: (1) work-related asthma; (2) occupation (healthcare workers/nurses); (3) cleaning and disinfection; and (4) exposure. Three databases were searched: Embase, PubMed, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) database. Data were extracted related to three main components of risk assessment: (1) exposure frequency, (2) exposure intensity, and (3) exposure duration. Latency data were analyzed using an exponential distribution fit, and extracted concentration data were compared to occupational exposure limits. The final number of included sources from which data were extracted was 133. Latency periods for occupational asthma were exponentially distributed, with a mean waiting time (1/λ) of 4.55 years. No extracted concentration data were above OELs except for some formaldehyde and glutaraldehyde concentrations. Data from included sources also indicated some evidence for a dose-response relationship regarding increased frequency yielding increased risk, but this relationship is unclear due to potential confounders (differences in role/task and associated exposure) and the healthy worker effect. Data priority needs to include linking concentration data to health outcomes, as most current literature does not include both types of measurements in a single study, leading to uncertainty in dose-response relationships.

Pharmacists' perspectives on school stock inhaler access for children.

Several states in the United States (U.S.) have laws permitting stock inhalers, including short-acting beta-agonist inhalers, such as albuterol, and spacers to be prescribed to, dispensed to, and stocked in schools for use in students in respiratory distress, based on a protocol. This survey study assessed Arizona pharmacists' (1) levels of comfort for dispensing a short-acting beta-agonist inhaler to an individual child versus a stock inhaler to a school, and (2) awareness of the related Arizona state law. Researchers surveyed pharmacists licensed in Arizona who self-reported practicing in an outpatient pharmacy setting. Among 251 pharmacist participants, 62% practiced in a chain community pharmacy. About 80.8% felt comfortable filling a prescription for an albuterol inhaler in a pediatric patient case, whereas only 26.7% felt comfortable filling a prescription for albuterol inhalers to be used as stock inhalers for a given school. Among those who would not fill the stock inhaler prescription, only 5.5% reported awareness of the state law compared to 42.6% of those who would fill it (p < 0.0001). This survey identified a lack of pharmacist awareness of state laws pertaining to stock inhalers for schools.

The Implementation and Evaluation of a Stock Epinephrine for Schools Program in Maricopa County, Arizona.

The increasing rate of food allergies in children, combined with the role of food as an integral part of the school day has led to the emergence of anaphylaxis as a daily threat to students, regardless of prior allergy diagnosis. Stock epinephrine-non-patient specific epinephrine auto-injectors that may be used during emergencies-is a means for schools to prepare for anaphylactic events and protect children with allergies. The Maricopa County Department of Public Health initiated the School Surveillance and Medication Program (SSMP), a data capture program, to facilitate the process of stocking epinephrine in schools. Spearheaded by the implementation efforts of the Kyah Rayne Foundation, program enrollment increased 146% between the 2020-2021 and 2021-2022 school years. The increased proportion of schools enrolled in the SSMP and the number of school personnel trained to administer epinephrine demonstrates the feasibility of school-centered stock epinephrine programs and validates strategies for increasing program uptake.

Harmful algal bloom aerosols and human health.

Harmful algal blooms (HABs) are increasing across many locations globally. Toxins from HABs can be incorporated into aerosols and transported inland, where subsequent exposure and inhalation can induce adverse health effects. However, the relationship between HAB aerosols and health outcomes remains unclear despite the potential for population-level exposures. In this review, we synthesized the current state of knowledge and identified evidence gaps in the relationship between HAB aerosols and human health. Aerosols from Karenia brevis, Ostreopsis sp., and cyanobacteria were linked with respiratory outcomes. However, most works did not directly measure aerosol or toxin concentrations and instead relied on proxy metrics of exposure, such as cell concentrations in nearby waterbodies. Furthermore, the number of studies with epidemiological designs was limited. Significant uncertainties remain regarding the health effects of other HAB species; threshold dose and the dose-response relationship; effects of concurrent exposures to mixtures of toxins and other aerosol sources, such as microplastics and metals; the impact of long-term exposures; and disparities in exposures and associated health effects across potentially vulnerable subpopulations. Additional studies employing multifaceted exposure assessment methods and leveraging large health databases could address such gaps and improve our understanding of the public health burden of HABs.

Vaping and Sleep as Predictors of Adolescent Suicidality.

PURPOSE: To investigate sleep quantity as a moderator of vaping and self-reported suicidality among adolescents. DESIGN: Cross-sectional. Setting: United States high schools. SAMPLE: 10,520 high-school students with complete data on the primary outcome of suicide attempt in the past year (76.9% response rate). MEASURES: 2019 Youth Risk Behaviors Survey. ANALYSIS: Logistic regression to examine main effects and potential moderation. RESULTS: Students with under seven sleep hours on school nights (OR = 2.6; 95% CI = 2.1-3.3) and who vaped in the past month (OR = 3.0; 95% CI = 2.1-3.9) had higher odds of attempting suicide in the last year. Sleep quantity moderated the relationship between vaping and suicidal thoughts in the past year (P = .01) but did not moderate the relationship between vaping and a suicide plan (P = .15) or suicide attempts (P = .06). Specifically, vaping had a smaller effect on suicidal thoughts among students who slept under seven hours on school nights (OR = 1.8) compared to the descriptively larger effect among participants with more sleep (OR = 2.5). CONCLUSIONS: Students who vape or report low sleep quantity would be ideal participants in suicide prevention interventions as they may be at higher risk for suicidality. Organizations implementing sleep or vaping interventions should incorporate information regarding the higher odds of suicide among students with low sleep quantity or vaping habits.

The Changing Job of School Nurses during the COVID-19 Pandemic: A Media Content Analysis of Contributions to Stress.

School nurses and unlicensed assistive personnel (UAPs) are essential to the health and wellness of school children. However, most US schools do not have a full-time licensed nurse. During the COVID-19 pandemic, school nurses and UAPs have been integral in ensuring that the health needs of students were met. They have seen a marked increase in their responsibilities included implementing COVID-19 mitigation strategies, screening for symptoms, testing students and staff, conducting contact tracing and data collection, and ensuring the implementation of rapidly changing COVID-19 guidelines and protocols for schools. The objective of this study was to explore COVID-19 occupational changes and their contributions to stress among school nurses and UAPs through a content analysis of local and national media articles. A Google search of articles published between February 2020 and September 2021 was conducted using the following search terms: 'school nurse', 'COVID-19', 'health aide', 'stress', and 'experiences'. A search was also conducted in Nexis Uni. Articles were included if the topic discussed school nurses or UAPs and COVID-19. All articles that examined nurses in other settings were excluded from the review. We examined topics and themes temporally (from February 2020 to September 2021) and spatially (i.e. the frequency by US state). Overall, 496 media articles discussing school nurses and COVID-19 were included in our review. The highest volume of articles was from September 2021 (22%, 111/496). Other months with relatively high volume of articles included August 2020 (9%, 43/496), January 2021 (10%, 47/496), February 2021 (9%, 44/496), and August 2021 (8%, 39/496). These larger article volumes coincided with notable COVID-19 events, including returning to school in the fall (August 2020 and August 2021), school nurses assisting with vaccine rollouts among adults in the USA (January/February 2021), concerns regarding the delta variant (August/September 2021), and vaccine rollouts for children ages 12-15 (September 2021). The representation of articles spatially (national, state, regional, or local) was 66 (13%) articles at national level, 217 (44%) state level, 25 (5%) regional level, and 188 (38%) local news at the city and/or village level. Pennsylvania had the highest frequency of articles, but when standardized to the state population, Alaska had the highest rate of media per 100 000 people. Three major themes were identified in our analysis: (i) safety; (ii) pandemic-related fatigue/stress; and (iii) nursing shortage/budget. The most represented theme for articles before September 2021 was that of safety. Over time, the themes of pandemic-related fatigue/stress and nursing shortage/budget increased with the most notable increase being in September 2021. The COVID-19 pandemic has resulted in new occupational risks, burdens, and stressors experienced by school nurses and UAPs. School nurses play a critical role in disease surveillance, disaster preparedness, wellness and chronic disease prevention interventions, immunizations, mental health screening, and chronic disease education. Furthermore, they provide a safety net for our most vulnerable children. Given that school nurses were already over-burdened and under-resourced prior to the pandemic, characterization of these new burdens and stressors will inform emergency preparedness resources for school health personnel during future pandemics or outbreaks.

The Association Between Duration of School Garden Exposure and Self-Reported Learning and School Connectedness.

When students feel connected to their school, they experience positive health and academic outcomes. In contrast, school disengagement is a predictor of dropout, delinquency, and substance use. School garden programming has the potential to help children achieve academic outcomes and feel connected to their school. Unfortunately, most school garden research has been conducted with white, affluent study participants. We describe the results of a secondary analysis utilizing data from an evaluation of a university-supported community school garden program (CSGP). Using a cross-sectional survey study design, we examined the impact of school garden programming in Title I schools on primarily Latino/a (Hispanic) elementary student self-reported learning and feelings of school connectedness by comparing students with ≤1 year exposure to those with >1 year. Social cognitive theory formed the conceptual basis for the analysis. Duration of school garden exposure did not have a significant association with self-reported learning or feelings of school connectedness. Regardless of past exposure, fifth-grade students, females, and those who identify as Latino/a (Hispanic) felt that school garden programming improved their learning. Latino/a (Hispanic) students who participate in school garden programming may also feel a greater sense of connection to their teachers and peers at school. Qualitative results demonstrated that most students enjoyed spending time in the garden and indicated that participating in the program helped them learn new things and feel connected to their school. If individuals who may be disadvantaged because of systemic racism, such as Latino/a (Hispanic) students, can benefit from school garden programming, such interventions should be further investigated and prioritized.

COVID-19 on the Navajo Nation: experiences of Diné families of children with asthma.

OBJECTIVE: The first case of COVID-19 on the Navajo Nation (NN) was found on March 17, 2020. Even with strong public health efforts, NN saw the highest per capita infection rate in the US during May of 2020 with 2450/100,000. To determine the impact of COVID-19 on families of children with asthma on the NN, families participating in the NHLBI funded Community Asthma Program were contacted to see if they would share their experiences. METHODS: Sixty-six of 193 families (34%) were interviewed.Results: The average age of the child with asthma was 13.5 (SD = 3.9) and 33% were female. Most Diné children with asthma in our study did not contract COVID-19. However, the pandemic had a significant impact on them and their families. Many family members contracted COVID-19, some children lost family members, and half of interviewed parents reported a decline in their child's mental health. Twenty-five percent of families sought the help of a traditional healer. Many accessed medical care through telehealth and most were able to obtain asthma medications when needed.Conclusions: Despite significant challenges, our research indicated resilience among Navajo families.

Roflumilast May Increase Risk of Exacerbations When Used to Treat Poorly Controlled Asthma in People with Obesity.

Rationale: People with obesity often have severe, difficult-to-control asthma. There is a need to develop better treatments for this population. One potential treatment is roflumilast, a phosphodiesterase 4 inhibitor, as it is reported to have efficacy for the treatment of asthma and can promote weight loss. Objectives: To investigate the potential efficacy of roflumilast for the treatment of poorly controlled asthma in people with obesity. Methods: A randomized, double-masked, placebo-controlled trial of 24 weeks of roflumilast versus placebo for the treatment of poorly controlled asthma in people with obesity (body mass index of 30 kg/m2 or higher). The primary outcome was a change in ACT (Asthma Control Test) score. Results: Twenty-two people were randomized to roflumilast and 16 to placebo. Roflumilast had no effect on change in the ACT (increased by 2.6 [interquartile range (IQR), 0.5-4.4] in those on roflumilast vs. 2.0 [IQR, 0.7-3.3] in those on placebo). Participants assigned to roflumilast had a 3.5-fold (relative risk [RR] 95% confidence interval [CI], 1.3-9.4) increased risk of an episode of poor asthma control and an 8.1-fold (RR 95% CI, 1.01-65.0) increased risk of an urgent care visit for asthma. Ten participants (56%) assigned to roflumilast required a course of oral corticosteroids for asthma exacerbations, and none in the placebo group. Participants losing 5% or more of their body weight experienced a clinically and statistically significant improvement in asthma control (ACT increased by 4.4 [IQR, 2.5-6.3] vs. 1.5 [IQR, 0.0-3.0] in those who lost less than 5%). Conclusions: Roflumilast had no effect on asthma control. Of concern, roflumilast was associated with an increased risk of exacerbation in obese individuals with poorly controlled asthma. These results highlight the importance of studying interventions in different subpopulations of people with asthma, particularly people with obesity and asthma who may respond differently to medications than lean people with asthma. Weight loss of at least 5% was associated with improved asthma control, indicating that interventions other than roflumilast promoting weight loss may have efficacy for the treatment of poorly controlled asthma in people with obesity. Clinical trial registered with www.clinicaltrials.gov (NCT03532490).