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. Author manuscript; available in PMC: 2023 Jul 11.
Published in final edited form as: J Allergy Clin Immunol Pract. 2021 Oct 18;10(2):517–524.e2. doi: 10.1016/j.jaip.2021.10.016

Nebulizer Use by Black and Latinx Adults with Moderate to Severe Asthma

Andrea Apter a,*, Jennifer K Carroll b,c,*, Juan Carlos Cardet d, Rubin Cohen e, Alex D Colon-Moya f, Brianna Ericson g, Victoria E Forth g, Claudia Gaefke d, Nancy Maher g, Wilfredo Morales-Cosme h, Jacqueline Rodriguez-Louis g, Abigail Tulchinsky g, Elliot Israel g
PMCID: PMC10334854  NIHMSID: NIHMS1905461  PMID: 34673286

Abstract

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.

Keywords: Nebulizer, Metered-dose inhaler, MDI, Rescue inhaler, SABA, Black adults, Latinx adults, Uncontrolled asthma

INTRODUCTION

Short-acting beta-2 agonists (SABAs), such as albuterol, are often used for quick relief of asthma symptoms. The SABAs may be delivered by a metered-dose inhaler (MDI) plus holding chamber or spacer, or a nebulizer. The MDIs provide the same or better delivery, are less likely to cause aerosol spread, have fewer adverse effects, and may cost patients less than a nebulizer, depending on insurance coverage.1,2 Despite potential advantages of MDIs, we lack understanding of patient preference, experiences, and decision making about the use of nebulizers versus inhalers for rapid symptom relief.

This gap in understanding became apparent during work on the PeRson EmPowered Asthma RElief (PREPARE) Study, a randomized, open-label, pragmatic study funded by the Patient-Centered Outcomes Research Institute.3 In this study, participating adults were randomized either to an additional puff of the inhaled corticosteroid (ICS) beclomethasone (80 μg/puff) with each as-needed puff of their MDI containing SABA (intervention) or to enhanced usual care (control). If a patient in the intervention group used nebulized SABA, we recommended 5 puffs of ICS be used with each nebulization. We expected little use of nebulizers yet were surprised to discover that many participants reported owning and using a nebulizer. This prompted us to explore nebulizer usage in our population.

The primary objective of this study is to describe the history, experiences, and preferences regarding nebulizer use among Black and Latinx adults with uncontrolled asthma. The secondary objectives are to understand what types of symptoms and situations prompt nebulizer use, and how nebulizer use compares/contrasts with the use of an MDI, in Black and Latinx adults with asthma. Answers to these questions will help improve our understanding of the experience of people with asthma, support their self-management, and optimize treatment recommendations.

METHODS

As mentioned, this is a substudy of the PREPARE Study,3 which was funded by the Patient-Controlled Outcomes Research Institute (PCS-1504–30283) and received approval from the Massachusetts General Brigham institutional review board. The PREPARE study design and methods have been published previously.3

We report our substudy methods here per the Consolidated Criteria for Reporting Qualitative Studies4 for rigor in qualitative research.

Study design

We used a Rapid Assessment Procedures qualitative methodology for our analysis,5,6 informed by grounded theory.710 Rapid qualitative analysis techniques have been used previously in health services research and related fields.6,1113

Eligibility criteria

To be eligible, individuals had to be enrolled in the PREPARE study. That is, they were 18 to 75 years of age, self-identified as African American/Black or Hispanic/Latinx, had a history of asthma for at least 1 year, were prescribed daily ICS therapy, and had a baseline Asthma Control Test score of 19 or less, or an asthma exacerbation in the past year. To be eligible for this qualitative substudy, PREPARE participants were required to (1) be from one of the PREPARE sites that ceded to Massachusetts General Brigham’s institutional review board (12 of the 19 PREPARE sites met this criterion) and (2) have indicated use of a nebulizer at least once in the past month on both their baseline survey and at least 1 additional monthly survey.

Participant-sampling strategy

The study team mailed letters to 252 participants at 12 participating sites explaining the substudy and inviting their participation. Of this group, 105 participants, representing 11 of the 12 sites, expressed interest in the study. A study team member contacted interested individuals to schedule a phone call, obtain informed consent, and conduct the interview. The team interviewed the first 40 individuals of the 105 who responded on a first-come-first-served basis. The following targets were predefined and achieved, divided equally between intervention and control participants: 20 Black, 10 Latinx English-speaking, and 10 Latinx Spanish-speaking individuals. The predefined targets were chosen based on feasibility, cost, and ability to collect sufficient data for the domains of interest.

Informed consent process and patient remuneration

Three study team members (A.T., V.E.F., C.G.) obtained informed consent and conducted interviews. One was bilingual in Spanish and English. All had backgrounds in pulmonary medicine and research and were trained in qualitative interviewing. The study team member called each individual at their scheduled time, obtained verbal informed consent, and conducted the interview. Interviews were conducted from September 2019 through April 2020 and were approximately 30 minutes in duration. Participants received $25 in remuneration upon completion of the interview.

Data source/interview domains

The data sources used for this substudy consisted of English and Spanish transcripts from the recorded phone interviews and descriptive data from the baseline survey. The interview domains were asthma medication use, nebulizer characteristics, nebulizer history and use, rescue inhaler history and use, insurance/copay/medication cost issues, and important events or advice received regarding asthma. Appendix 1 (available in this article’s Online Repository at www.jaci-inpractice.org) shows the interview guide. We tested interview questions with 4 PREPARE patient partners, 2 Black (both English-speaking) and 2 Latinx (1 English-speaking and 1 Spanish-speaking). The patient partners provided feedback on the questions, process, and overall flow of the interview which was used to modify the interview guide and questions.

Data preparation and management

A medical transcription company transcribed all interviews. Transcriptions were completed in May 2020. Professional translation was performed for interviews conducted in Spanish. One team member (V.E.F.) reviewed all transcripts to remove any personal information (eg, name, location) before review by other analysis team members.

Data analysis

We assembled an analysis team with attention to team composition and diversity in several ways: gender, racial and ethnic identities, roles on the PREPARE project, professional background, and level of experience with qualitative research. Roles on the PREPARE study were patient partners (A.D.C.M., W.M.C.), research coordinator (A.T.), coinvestigator and expert stakeholder (R.C.), asthma educator (J.R.L.), pulmonary physician assistant (V.E.F.), asthma specialist physicians (A.A., J.C.C., R.C., C.G.), and family physician (J.K.C.). Two team members (A.A., J.K.C.) conducted team training to orient the group to overall goals, timeline, work plan, qualitative research, Rapid Assessment Procedures methods, and other project logistics. Next, the team identified and reached a consensus on the critical domains to serve as the basis for understanding participants’ nebulizer use: nebulizer characteristics, nebulizer history, reasons for nebulizer use, preferences for nebulizer versus inhaler use, and overall preference. All members of the analysis team were blinded to identifying participant information.

For the data reduction phase, the team prepared summary templates. Two team members read each of the 40 transcripts and designed a summary template for each transcript, noting their findings for the domains mentioned earlier.

When the summary templates were completed, the team chose 2 participant characteristics—race and ethnicity (Black or Latinx) and primary language (English or Spanish)—for the matrix development phase. These characteristics were chosen for 2 reasons. First, the team felt these characteristics would provide an insightful lens to explore themes and interpretations of the domains of interest. These characteristics are also the focus of other analyses for the PREPARE study. Second, distribution across these characteristics was balanced, which permitted an analysis of the findings based on these characteristics.

Following other published methods for matrix development,5,6 the team prepared matrices and critically appraised the matrices based upon guiding questions for interpretation. Each team member was paired with 1 or 2 other team members to conduct matrix analyses on sets of 10 each of the total sample of 40 transcripts. Then, the entire team met to discuss findings from the matrix analyses and prepare the narrative account of the findings. Throughout the analytic process, and consistent with central practices of grounded hermeneutic research,14 corroborating and legitimizing findings occurred via inclusion of the patient partners’ and clinicians’ perspectives as members of the research team. The principles of grounded theory and hermeneutics (ie, the interpretive process) research that we adopted were that (1) the narrative accounts and experiences of the participants have meaning; (2) meaning is not just verbalized, but expressed in actions, behaviors, and experiences; (3) human behavior is rarely fixed, clear, and unambiguous; and (4) interpretation is necessary to understand human behavior.14

Data saturation

Saturation was defined in 2 ways. First, we obtained verbal consensus from the analysis team that we had reached redundancy in the findings. Second, 2 analysis team members (A.A., J.K.C.) reviewed the matrix analysis materials, which also indicated redundancy of themes across all 4 analysis subgroups and their associated data sources and matrix documents.

The analysis began in August 2020 and was completed in January 2021.

RESULTS

Patient characteristics

Demographic and health characteristics of the overall PREPARE population and the substudy participants are described in Table I. The substudy participants represented 11 of the 19 PREPARE study sites.

TABLE I.

Participant characteristics

Nebulizer substudy (n = 40) PREPARE population (n = 1,201)


Characteristic African American/Black (n = 20) Hispanic/Latinx (n = 20) African American/Black (n = 603) Hispanic/Latinx (n = 598)

Age (y), mean (SD) 49.8 (12.6) 50.4 (11.6) 48.6 (13.4) 47.7 (14.0)
Sex reported at birth, n (%)*
 Female 19 (95) 16 (80) 508 (84) 497 (83)
 Male 1 (5) 4 (20) 95 (16) 101 (17)
Language, n (%)
 English 20 (100) 10 (50) 603 (100) 331 (55)
 Spanish 0 (0%) 10 (50) 0 (0) 267 (45)
Region, n (%)
 Northeast 9 (45) 11 (55) 185 (31) 301 (50)
 Ohio Valley central 5 (25) 1 (5) 128 (21) 45 (8)
 Puerto Rico 0 (0) 4 (20) 0 (0) 102 (17)
 Southeast 6 (30) 4 (20) 290 (48) 80 (13)
 Southwest 0 (0) 0 (0) 0 (0) 70 (12)
Age at asthma diagnosis (y), n (%)
 <5 7 (35) 6 (30) 132 (25) 156 (27)
 5–12 1 (5) 3 (15) 101 (19) 111 (20)
 13–18 1 (5) 2 (10) 46 (9) 58 (10)
 19–40 7 (35) 4 (20) 152 (29) 167 (29)
 41–60 3 (15) 5 (25) 84 (16) 73 (13)
 >60 1 (5) 0 (0) 12 (2) 4 (<1)
 Missing 0 0 76 29
Baseline asthma medication use, n (%)
 Short-acting bronchodilator rescue inhaler (SABA, SAMA, SABA/SAMA) 20 (100) 20 (100) 603 (100) 598 (100)
 ICS 9 (45) 6 (30) 218 (36) 235 (39)
 ICS/LABA 13 (65) 15 (75) 430 (71) 429 (72)
 Long-acting bronchodilator (LABA, LAMA, LAMA/LABA) 6 (30) 2 (10) 61 (10) 88 (15)
 LTRA 13 (65) 15 (75) 282 (47) 316 (53)
 Biologic 1 (5) 2 (10) 11 (2) 25 (4)
Ever use of a nebulizer for shortness of breath or for SABA administration, n (%) 20 (100) 20 (100) 371 (61) 433 (72)
Baseline reported frequency of nebulizer use per wk, mean (SD) 3.7 (5.1) 3.4 (4.0) 3.0 (5.1) 2.7 (4.3)
Baseline reported frequency of nebulizer use per wk by category, n (%)
 0 4 (20) 5 (25) 124 (33) 138 (32)
 1–2 8 (40) 8 (40) 140 (38) 167 (39)
 3–4 4 (20) 1 (5) 46 (12) 47 (11)
 ≥5 4 (20) 6 (30) 62 (17) 81 (19)
 Missing 0 0 231 165
Baseline ACT score, mean (SD) 14.6 (3.6) 13.1 (4.4) 15.0 (4.4) 14.3 (4.5)
Baseline ASUI§ score, mean (SD) 0.69 (0.17) 0.55 (0.24) 0.68 (0.21) 0.65 (0.22)
Baseline history of asthma hospitalization in past y, n (%)
 0 18 (90) 10 (50) 496 (82) 476 (80)
 1 0 (0) 7 (35) 63 (10) 69 (12)
 2 0 (0) 1 (5) 23 (4) 27 (5)
 3+ 2 (10) 2 (10) 21 (3) 26 (4)
Baseline history of corticosteroid bursts in the past y, n (%)
 0 5 (25) 1 (5) 226 (37) 211 (35)
 1 7 (35) 10 (50) 159 (26) 169 (28)
 2 3 (15) 2 (10) 102 (17) 80 (13)
 3+ 5 (25) 7 (35) 116 (19) 138 (23)
Baseline number of comorbidities, n (%)
 0 4 (20) 7 (35) 151 (25) 206 (35)
 1 3 (15) 3 (15) 148 (25) 128 (21)
 2 5 (25) 3 (15) 155 (26) 97 (16)
 3 3 (15) 6 (30) 75 (12) 92 (15)
 4+ 5 (25) 1 (5) 74 (12) 75 (13)
General health (CDC HRQOL-4), n (%)
 Excellent 1 (5) 2 (10) 13 (2) 9 (2)
 Very good 0 (0) 1 (5) 54 (9) 74 (12)
 Good 7 (35) 1 (5) 216 (36) 178 (30)
 Fair 9 (45) 12 (60) 261 (43) 268 (45)
 Poor 3 (15) 4 (20) 59 (10) 69 (12)
Days per mo physical health not good, mean (SD) 11.4 (12.3) 12.5 (11.5) 10.0 (10.6) 11.7 (10.6)
Days per mo mental health not good, mean (SD) 7.6 (9.0) 10.3 (11.0) 7.4 (10.1) 9.2 (10.3)

ACT, Asthma Control Test; AIDS, acquired immunodeficiency syndrome; ASUI, Asthma Symptom Utility Index; CDC HRQOL-4, Healthy Days Core Module; COPD, chronic obstructive pulmonary disease; HIV, human immunodeficiency virus; LABA, long-acting beta-2 agonist; LAMA, long-acting muscarinic antagonist; LTRA, leukotriene receptor antagonist; SAMA, short-acting muscarinic antagonist.

*

Gender disparities in asthma prevalence15 and perceptions of asthma control16 may have influenced recruitment for PREPARE, and thus, this substudy, resulting in greater enrollment of women than men.

Some participants were taking both ICS and ICS/LABA.

The ACT is a patient self-administered tool for assessing level of asthma control.17 The ACT is a validated, 5-item questionnaire that assesses asthma symptoms, rescue medication use, daily functioning, and overall perception of asthma control, with a 4-wk recall. Scores on each item range from 1 to 5 and the total score ranges from 5 to 25. ACT scores of 20 to 25 are classified as well-controlled asthma; 16 to 19 as not well-controlled; and 5 to 15 as very poorly controlled.18

§

The ASUI, which assesses preference-based quality of life, is a validated, 10-item questionnaire designed to assess 4 asthma symptoms (cough, wheeze, dyspnea, and nocturnal awakening) and side effects from asthma medications over a 2-wk recall period. The frequency and severity of each item are assessed on a 4-point Likert scale. The items are then weighted according to patient preferences, and the summary score is a continuous scale ranging from 0 (worst possible symptoms) to 1 (no symptoms).19

Comorbidities included heart disease, cancer, stroke, diabetes, chronic kidney disease, COPD, HIV/AIDS, and hypertension.

General health was assessed using question 1 from the CDC HRQOL-4.20

Substudy participants were 50 years old on average, mostly female, primarily residing in the Northeast, and with baseline Asthma Control Test scores indicating poorly controlled asthma (≤19).18 Substudy participants reported nebulizer use of about 3 or 4 times per week at baseline. The majority of participants had multiple chronic conditions (eg, diabetes, hypertension, obesity). Sixty percent of Black and 80% of Latinx participants reported their general health to be fair or poor.

Of the 1,201 participants in the PREPARE study, 61% (n = 371) of Black and 72% (n = 433) of Latinx participants reported using a nebulizer for quick relief of their asthma symptoms.

Domains

We describe the key themes and findings in each domain.

Nebulizer characteristics

Most participants had a plug-in nebulizer that they kept in a consistent location at home, typically their bedroom. Nearly all participants were able to describe the exact location where they stored their nebulizer. Most left their nebulizer at home when they went out; the few that did take it did so for significant travel or extended time away from home. Only 1 participant indicated she regularly took it with her to work.

Several participants shared a nebulizer or received nebulizer solution from a family member. For example, 1 English-speaking Latinx participant (patient 25) stated, “I live in a household full of nine people and eight of us have asthma. So really, you know, we never run out of asthma medication.” The most prominent themes for this domain were that participants (1) consistently described a specific habit and routine for their nebulizer storage and patterns of use, and (2) tended to use their nebulizer at home and some shared it with others in the home.

History of nebulizer use

Nearly all participants reported a longstanding history of nebulizer use. No participant in this sample had used a nebulizer for fewer than 2 years; most had used one for several years or, in some cases, decades. Many individuals described a history of asthma beginning at a young age and had used nebulizers since childhood or early adult years. Many could recall and describe a specific context, illness experience, and/or interaction with their physician or medical team associated with nebulizer prescription and subsequent use. Nebulizers were prescribed by allergists, emergency department or hospital physicians, pediatricians, pharmacists, primary care physicians, and pulmonologists. Frequently, the prescription for a nebulizer was related to an attempt to avoid emergency room visits or hospitalizations. As 1 Black participant (patient 14) explained, “My asthma was not under control. I needed to have [a nebulizer] at home because I was constantly in the emergency room all the time. So, if you’re at home, if you have a nebulizer, at least you can try it at home before you go to the hospital.”

There was variation in the frequency of nebulizer use. Daily use was common, and frequency ranged from less than daily to up to 6 times daily. As 1 Black person (patient 5) commented, “When I have [asthma] under control, I don’t have to take many [nebulizers]....I could just take it as needed. But when I catch a cold or the pollen [is heavy] or I’m walking or I’m trying to do some activities with the kids, …then up to 6 times a day.” Most participants acknowledged trying their inhaler first, and then using the nebulizer as second line or as a “last resort” if inhaler therapy proved ineffective. One Spanish-speaking Latinx participant (patient 33) explained, “When I use the… pump. I see that it doesn’t help me much, well, then I go use the machine [nebulizer].” There was some variation in this general pattern in that some individuals, often those who had had a nebulizer since early childhood, reported that they typically used the nebulizer first. A few participants described using a nebulizer without symptom severity or progression, generally because the individual anticipated exposure to triggers known to cause exacerbations in the past, or as prophylaxis before exercise or work. For example, an English-speaking Latinx person (patient 23) talked about a nebulizer “night cap” to ensure a good night’s sleep.

There was variation among participants in the extent to which cost affected their nebulizer use. Some participants reported that price was problematic for all of their asthma medications, including their nebulizer solution, and that copays were significant and burdensome. One Black participant (patient 11) reported a $35 copay for inhaler refills, stating “If I don’t have the money, they don’t give it to me.” Some patients who shared nebulizers with family members mentioned cost of drugs as a reason. But, generally speaking, nebulizer medication tended to be less expensive. Some participants stated that their nebulizer medication was fully covered by their insurance or available at no cost via other means (ie, a charity program).

Participants frequently described having reasonably large quantities of nebulizer medication dispensed at a time. Consequently, they required less-frequent refills of the nebulizer medication, which was convenient, especially if running low on other asthma medications. One patient tried to extend the interval of asthma medications; when asthma worsened due to extending the interval, she or he would use a nebulizer.

For these reasons, participants for whom cost was problematic tended to prefer the nebulizer over the inhaler.

Reasons for nebulizer use

All participants described similar symptoms that led them to use the nebulizer: cough, wheezing, chest tightness, and shortness of breath with difficulty breathing. The severity and progression of these symptoms that resulted in nebulizer use were consistently described and usually indicated significant functional impairment, such as difficulty walking or speaking. Less frequently, a participant would use a nebulizer in anticipation of an exposure such as to an allergen.

Whereas participants understood that both the nebulizer and the inhaler were rescue therapies, most described using the nebulizer as the next step if the inhaler was ineffective. Symptoms that were either refractory to the inhaler or escalating despite use of the inhaler were the predominant scenarios leading to nebulizer use.

Another theme described under this domain was the use of nebulizers to prevent emergency department visits or hospitalization. As described previously, a desire to stay out of the hospital, attempt to manage asthma exacerbations at home, and replicate treatment given in the emergency department or hospital were all frequently mentioned by participants.

Comparison of nebulizer versus inhaler

Participants noted several advantages and disadvantages for both nebulizer and inhaler use.

Setting and convenience were mentioned as factors. Because nebulizers were infrequently taken outside of the home, participants would more commonly use their nebulizer while at home and the inhaler outside the home.

Most participants felt that the nebulizer was more effective than the inhaler. For example, 1 Black participant (patient 16) stated that nebulizer medication was “more powerful,” “stronger” medicine, which “goes deeper” and “settles in the lungs” compared with the inhaler. Another Spanish-speaking Latinx individual (patient 33) remarked, “The nebulizer changes the outcome […] because it’s like I feel that it goes further in. Cause I breathe deeply and it’s more than just two pumps.” Although opinions were mixed as to whether the time to onset of relief of symptoms was faster for the nebulizer versus the inhaler, most felt that relief of symptoms was more complete and longer lasting with the nebulizer than with the inhaler. Several participants mentioned the unpleasant side effects of feeling anxious and jittery, both as indications that the nebulizer medication was more potent and as reasons why they limited the nebulizer use to only severe or escalating symptoms.

Overall preference

Overall preference for the nebulizer versus inhalers was not always explicitly stated. When symptoms were severe, progressive, and refractory to other asthma medications, nearly all participants preferred the nebulizer. The general preference for the nebulizer was that it worked faster, provided more complete and long-lasting relief, and in some cases was less expensive and in more ready supply. Those who preferred the inhaler stated that it was effective for milder symptoms, had quick onset, was convenient (ie, portable and easier to administer, especially when outside the home), and did not have the adverse effects of the nebulizer.

Similarities and differences based on patient characteristics

In examining our matrices by the predetermined patient characteristics of interest (race and ethnicity, Black vs Latinx; and language spoken, Spanish vs English), we found that the overall results for the key domains were more similar than different. The few differences noted, and infrequently so, were that 2 Spanish-speaking Latinx participants mentioned using the nebulizer prophylactically; this finding was not observed with the other groups. Second, Latinx participants tended to comment more universally that the nebulizer was lower cost and more convenient. Whereas this was also expressed among Black participants, views about cost and convenience were more variable.

Impact of coronavirus disease 2019 on nebulizer use

Owing to the timing of this study relative to the onset of the coronavirus disease 2019 (COVID-19) pandemic, our interview guide was not designed to elicit COVID-specific discussion and did not contain any COVID-specific questions. We reviewed the transcripts of interviews that were conducted in March and April 2020 and did not identify any spontaneous COVID-related discussion among participants.

DISCUSSION

This qualitative study found that many patients use nebulizers to control refractory symptoms. Approximately 70% of the overall PREPARE cohort owns a nebulizer. Most of our substudy participants had had nebulizers for many years. Some patients revealed that they use nebulizers intermittently and may receive prescriptions from various clinicians and health care systems. Considering the long duration of nebulizer use for many participants, the possibility that a different clinician may have prescribed a nebulizer, and the practice of sharing nebulizer solutions, it is possible that use of a nebulizer may not always be known to patients’ current clinicians. Patients may not think to discuss their use with their current clinician, and clinicians may not consider asking about it. Findings from this study suggest that it is essential for clinicians to ask about the history, frequency, and context of nebulizer use to get a clear picture of the patient’s asthma control. Further, many of our participants characterized their general health to be poor, placing them at a higher potential risk for COVID-19—related complications. While asthma exacerbations decreased during the COVID-19 pandemic,21 nebulization has been identified as a high-risk activity owing to the generation of respiratory droplets and airborne particles. Thus, considering the frequent use of nebulizers in this population, it would be important to warn patients that nebulization may increase the risk of COVID-19 spread to those in their immediate area.

Many patients described side effects from using the nebulizer (eg, feeling “shaky”). Whether the shakiness is simply an adverse effect or has other clinical significance is not clear and worthy of further study. However, patients uniformly reported that nebulizers tended to work faster and better than inhalers. Thus, it seemed most patients felt the nebulizer provided some benefit.

We observed considerable variation in participants’ reports of costs of their asthma medication, and their level of concern about the costs. Asthma medication costs vary regionally and by insurance coverage, and clinicians may be unaware of the costs of medications or their patients’ level of concern about cost. Nebulizer costs can be variable depending on whether covered by Medicare, Medicaid, or commercial insurance. Nebulizer devices are billed as durable medical equipment. Thus, Medicare, Medicaid, and commercial insurance cover the cost of the machine. Some nebulizer solutions can be relatively inexpensive (eg, albuterol, budesonide, ipratropium, and DuoNeb cost $15 to $20 per month’s supply); others (eg, formoterol, arformoterol, glycopyrrolate and revefenacin) cost over $1,000/mo and are, therefore, unaffordable for patients without supplemental plans. Inhalers, conversely, are billed through prescription benefits, and may have expensive copays. For patients with Medicare Part D, inhalers (which cost $300 to 600 per device) can become unaffordable when reaching the donut hole, when a 25% copayment is required. Our findings suggest that cost is an issue affecting African American/Black and Hispanic/Latinx patients’ decision making about asthma medication use to some extent; a recommendation for clinicians is that they be aware of this and consider asking about cost as part of their discussions with patients.

This study’s findings should be considered in the context of its limitations and strengths. First, this is a substudy of a more extensive study with a sample size of 40 participants. Qualitative research involves relatively small sample sizes to provide a detailed description of patients’ thoughts, beliefs, and experiences. The aim of qualitative research is to capture the array of responses, not to count how many of each type. At 40 patient interviews, we had reached saturation; that is, we were no longer seeing new answers to our interview questions. Second, this paper reports on a specific population and it is not clear how these findings apply to other groups of asthmatic patients. Finally, we did not ask about spacer use, which could have affected participants’ perceptions of MDI effectiveness compared with nebulizer use.

Strengths of this study include the diversity of the analysis team, robust engagement with several patient partners, use of rigorous and established qualitative methods, and participants from 11 sites in the United States including Puerto Rico.

This study adds to our understanding of the real-world use of nebulizers in asthma. In this study, nebulizer use was common and, for many, preferable to MDI therapy. In order to adequately address asthma control and ensure that patients receive the most appropriate drug regimen, clinicians should routinely explore patients’ use of nebulizers.

What is already known about this topic?

Asthma guidelines recommend a metered-dose inhaler rather than a nebulizer for short-acting beta-2 agonist administration, except in the setting of severe asthma exacerbation. However, the real-world use of nebulizers may differ from guidelines.

What does this article add to our knowledge?

This study adds to our understanding of the history, experiences, and preferences regarding the use of nebulizers in Black and Latinx adults with uncontrolled asthma.

How does this study impact current management guidelines?

In order to adequately address asthma control and ensure that patients receive the most appropriate drug regimen, clinicians should routinely explore patients’ use of nebulizers.

Acknowledgments

We acknowledge Julia Harder, PharmD, who provided medical writing assistance, and Christopher Hvisdas, PharmD, from the University of Pennsylvania who reviewed the medication cost information.

We also acknowledge the several stakeholders who were active in developing the study design and implementation of this study, offering expert advice throughout this project.

Our operations stakeholders (Anne L. Fuhlbrigge, MD, MS; Wilson D. Pace, MD, FAAFP; Frank Rockhold, PhD; Lilin She, PhD; Maureen Fagan, DNP, FNP-BC, FAAN; Brian K. Manning, MPH; Joel B. Shields, MA; Paulina Arias Hernandez, MSW; and Jean Kruse, BA) oversaw study design and implementation.

Our patient partner stakeholders (Aracelis Diaz; Bridget Hickson; Margarita Lorenzi, MS; Suzanne Madison, PhD, MPH; Kathy Monteiro; Alexander Muniz Ruiz; Addie Perez; Richard Redondo; Dennis Reid; Janet Robles; Marsha Santiago; Opal Thompson; Joyce Wade; and Mary White) ensured that the patient voice is heard and incorporated into all aspects of the PREPARE study.

Our professional society stakeholders (Tamera Coyne-Beasley, MD, MPH, FAAP, FSAHM; Patricia Finn, MD; Michael Foggs, MD; Robert Lemanske, MD; Folashade Omole, MD, FAAFP) provided their expertise in asthma and the population being enrolled.

Our patient advocacy stakeholders (Mary K. Hart, MS, RRT, RCP, AE-C, FAARC, FCCP; Mario Herrera, MD, MPH; Barbara M. Kaplan, MPH; Sharon Schumack, MEd) contributed their expertise regarding the populations of interest and affirmed the patient voice is being heard.

Our expert scientific advisors (Juan C. Celedón, MD, DrPH; Michelle M. Cloutier, MD; Giselle Mosnaim, MD; Wanda Phipatanakul, MD, MS; Michael E. Wechsler, MD; Barbara P. Yawn, MD, MS) ensured all aspects of PREPARE are scientifically valid and relevant.

Our health policy experts (Sarah Alwardt, PhD; Tangita Daramola, MD, CFMM; Gretchen Hammer, MPH; Arif M. Khan, MD; Troy Trygstad, MD, CCNC; Sreekanth Chaguturu, MD) strengthened our pragmatic approach to the introduction of PARTICS into the daily flow of health care.

Our study site investigators (Ahmet Baydur, MD, FACP, FCCP; Paula J. Busse, MD; Rafael A. Calderon-Candelario, MD, MSc; Thomas B. Casale, MD; Ku-Lang Chang, MD, FAAFP; Geoffrey Chupp, MD; Michelle L. Hernandez, MD; Laura P. Hurley, MD, MPH; Sunit Jariwal, MD; Elina Jerscow, MD; David C. Kaelber, MD, PhD, MPH; Sylvette Nazario, MD; Magdalena Pasarica, MD, PhD; Victor Pinto-Plata, MD; Isaretta L. Riley, MD, MPH; Paul M. Stranges, PharmD; Kartik Shenoy, MD; Hazel Tapp, PhD; Jennifer Trevor, MD; Juan P. Wisnivesky, MD, DrPH) contributed with recruitment and study implementation.

This work was supported by a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (PCS-1504-30283). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee. J. C. Cardet’s contribution to the manuscript was funded by grant #K23AI125785 from the National Institute of Allergy and Infectious Diseases (NIAID). TEVA Pharmaceutical Industries, Ltd, provided the study drug used in the PeRson EmPowered Asthma RElief (PREPARE) study and pharmacy services for shipping the study drug. Circassia provided a clinical research grant and equipment.

Abbreviations used

COVID-19

Coronavirus disease 2019

HIV

Human immunodeficiency virus

ICS

Inhaled corticosteroids

MDI

Metered-dose inhaler

PREPARE

PeRson EmPowered Asthma RElief

SABA

Short-acting beta-2 agonist

ONLINE REPOSITORY

Appendix 1: Nebulizer substudy qualitative interview guide

If patient said on screening that they DO NOT use a nebulizer

  1. This first question is about the use of a nebulizer or “the machine,” which is a machine or device that usually plugs into a wall. It turns your asthma medicine into a mist, which can then be easily breathed in by wearing a mask or mouthpiece over 3 to 4 minutes either during an asthma attack or at certain times of the day. You said that you used a nebulizer on a survey when you were enrolled in the PREPARE study; has that changed since you were enrolled?
    1. If no: OK, so you use a nebulizer? If yes: Skip to question 2 below and ensure they are not confused and that they actually have a nebulizer and use it. If it seems like they have a nebulizer then proceed to question 1.
    2. If yes: Have you ever used a nebulizer?
      1. 1) If no: Your feedback about our questions will be really helpful. You mentioned when you were enrolled that you used a nebulizer; was the question confusing? Did you think a nebulizer was something else?
      2. 2) If yes: Ask when they last used a nebulizer. If within 6 months, then go through the questions below.

If the patient indicated that they DO use a nebulizer

  1. This first question is about the medicines you use for your asthma either every day or when you are having asthma symptoms. If you do not already have them, could you please get your asthma medicines for this part of our conversation?
    1. What asthma medicines do you take for your asthma? (If they do not mention the answers to the below questions, then go through them.)
      1. 1) What symptoms/when do you use your [name of controller inhaler]? How many puffs of this medicine do you usually use?
      2. 2) What symptoms/when do you use your [name of rescue inhaler]? How many puffs of this medicine do you usually use?
      3. 3) What symptoms/when do you use your nebulizer machine? What medicine(s) do you use in your nebulizer? How many treatments of your nebulizer do you usually use?
      4. 4) Where do you keep your medicines? (Ask about the physical location of each their medicines.)
      5. 5) How often do you take your asthma medicines? (Ask about each one.)
      6. 6) Who suggested you use the medicines that way (provider, friend, etc.)?
      7. 7) Do you ever use your asthma medicines differently than your health care provider would like you to because of cost (ie, you skip doses or use 1 puff instead of 2 puffs)? If yes: Ask them to explain.
      8. 8) Does your insurance cover the full cost of your asthma medicines? If yes: Skip to question 2.
        1. How often do you refill your rescue inhaler? How much do you pay each month/refill for your rescue inhaler?
          1. How often do you refill your rescue nebulizer medicine? How much do you pay each month/refill for your rescue nebulizer?
          2. How often do you refill your controller inhaler? How much do you pay each month/refill for your controller inhaler?
          3. If they have/use: How often do you refill your controller nebulizer? How much do you pay each month/refill for your controller nebulizer?
        2. Do you ever choose one asthma medicine over another because of cost? If yes: Please explain.
          1. If yes: If cost wasn’t an issue, which asthma medicine would you choose?
        3. Have you had any trouble getting your asthma medicines refilled because of cost? If yes: Please explain.
  2. Great, thanks for that information. Now I would like to focus a few questions about your nebulizer or “the machine.”
    1. Can you tell me what your nebulizer looks like?
    2. Does it plug into an electrical outlet?
    3. How long have you had this nebulizer?
    4. Where do you keep your nebulizer? Do you ever take it with you when you leave the house?
    5. How did you get a nebulizer (ie, doctor’s office, pharmacy, friend gave it to you)?
    6. Why did you get a nebulizer?
    7. How long have you been using a nebulizer (eg, since a child)?
    8. Do others in your home use the same nebulizer machine? Is there more than one nebulizer machine in your home?
  3. You mentioned you use it for [answer from question 1.iii above] reasons. Can you tell me when you first started using it that way? How long ago (eg, last year, when you were 12)?
    1. Who suggested you use it [as in question 1.3]?
    2. Have you always used it [as in question 1.3]?
    3. How often do you typically use your nebulizer in a week when your asthma is well controlled and you have few symptoms?
    4. How often do you typically use your nebulizer in a week when your asthma is poorly controlled and you have many symptoms?
    5. If they do not mention a regular schedule: Do you also use it on a regular schedule or only for rescue/acute symptoms?
  4. Tell me about when you use your nebulizer instead of your [name of rescue inhaler]. What/when would make you choose to use your nebulizer instead of your inhaler? (If they do not mention these symptoms, ask: Shortness of breath? Coughing? Wheezing?)
    1. How severe are your symptoms for you to use the nebulizer instead of your [name of rescue inhaler]?
    2. Do you ever also use your [name of rescue inhaler] to treat these problems? If yes: Tell me about when you use this inhaler.
    3. How soon after using your nebulizer are your symptoms relieved?
    4. How soon after using your inhaler are your symptoms relieved? If they say one was faster than the other: Ask if that plays into their decision making about which one they use first.
  5. I know we have focused a lot on your inhalers and nebulizer. I would like to go back and understand a little more about any important events or advice you have received about your asthma.
    1. What advice, suggestions, or recommendations have you received about your asthma? If they provide an answer: Ask who gave them the advice.
    2. Please describe any important memories about your asthma or asthma medicines that you feel are important to how you take your care of your asthma today.
  6. Do you have any other comments about your nebulizer or asthma medicines?

Footnotes

Conflicts of interest: A. Apter is an associate editor of the Journal of Allergy and Clinical Immunology, and a consultant for UpToDate; and reports research funding from the National Institutes of Health/National Heart, Lung, and Blood Institute (NIH/NHLBI) and the Patient-Centered Outcomes Research Institute (PCORI). J. K. Carroll reports grants or contracts from the National Institutes of Health (NCI, NHLBI, National Institute of Diabetes and Digestive and Kidney Diseases [NIDDK], Natonal Center for Complementary and Integrative Health), U.S. Centers for Disease Control and Prevention (CDC), Robert Wood Johnson Foundation, Helmsley Foundation, American Academy of Family Physicians Foundation, American College of Clinical Pharmacy, and Patient-Centered Primary Care Research Institute; and support for attending meetings and/or travel from the PCORI, American Academy of Family Physicians Foundation, and American College of Clinical Pharmacy; serves as a member of NCI’s Health Equity Task Force for Implementation Science in Cancer Prevention and Control; and in unpaid advisory roles for the CDC, North American Primary Care Research Group, American Board of Family Medicine, and American Academy of Pediatrics. J. C. Cardet reports honoraria from AstraZeneca and Genentech for work in their advisory boards, unrelated to this project. E. Israel reports grants or contracts from AstraZeneca, Avillion, Boehringer-Ingelheim, Genentech, GlaxoSmithKline, Gossamer Bio, the NIH, Novartis, Sanofi Genzyme/Regeneron, and TEVA; royalties or licenses from UpToDate; consulting fees from AB Science, Allergy and Asthma Network, Amgen, AstraZeneca, Avillion, Biometry, Cowen, Equillium, GlaxoSmithKline, Merck, NHLBI, Novartis, Pneuma Respiratory, PPS Health, Regeneron, Sanofi Genzyme, and TEVA; payment or honoraria for lectures from the Yale School of Medicine and the Westchester Medical Center; payment for expert testimony from Danaher Lagnese, Cambridge Medical Experts, and SettlePou; participation on a Data Safety Monitoring Board or Advisory Board for Novartis; unpaid membership in the National Asthma Education and Prevention Program Coordinating Committee; receipt of study drug from CSL Behring, Genentech, GlaxoSmithKline, Laurel Venture, OM Pharma, Sanofi Genzyme/Regeneron, Sun Pharma, and Vitaflo. The rest of the authors declare that they have no relevant conflicts of interest.

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