The Journal of Emergency Medicine, Vol. xx, No. x, pp. xxx, 2009 Copyright 2009 Published by Elsevier Inc.

Sunil Dhuper, MD,*†‡ Alpana Chandra, MD,*†‡ Aziz Ahmed, MD,*†‡ Sabin Bista, MD,† Ajit Moghekar, MD,† Rajesh Verma, MD,*†‡ Cynthia Chong, MD,*†‡ Chang Shim, MD,†‡ Hillel Cohen, DRPH,‡ and Sonia Choksi, MD*†‡ *North Central Bronx Hospital, Bronx, New York, †Jacobi Medical Center, Bronx, New York, and ‡Albert Einstein College of Medicine, Reprint Address: Sunil Dhuper, MD, Coney Island Hospital, 2601 Ocean Parkway, 2w6, Brooklyn, NY 11229 e Abstract—Background:
nebulizer groups, respectively (p ؍ 0.56). The median im-
equivalent efficacy of beta agonist delivery using a metered
provement in the symptom score was 7 (5–9) vs. 7 (4 –9) in
dose inhaler (MDI) with spacer vs. nebulizer in asthma
the spacer and nebulizer groups, respectively (p ؍ 0.78).
patients, use of a nebulizer remains standard practice. Ob-
The median cost of treatment per patient was $10.11
jectives: We hypothesize that beta agonist delivery with a
($10.03–$10.28) vs. $18.26 ($9.88 –$22.45) in the spacer and
MDI/disposable spacer combination is an effective and low-
nebulizer groups, respectively (p < 0.001). Conclusion:
cost alternative to nebulizer delivery for acute asthma in an
There is no evidence of superiority of nebulizer to MDI/
inner-city population. Methods: This study was a prospec-
spacer beta agonist delivery for emergency management of
tive, randomized, double-blinded, placebo-controlled trial
acute asthma in the inner-city adult population. MDI/
with 60 acute asthma adult patients in two inner-city emer-
spacer may be a more economical alternative to nebulizer
gency departments. Subjects (n ؍ 60) received albuterol
2009 Published by Elsevier Inc.
with either a MDI/spacer combination or nebulizer. The
spacer group (n
؍ 29) received albuterol by MDI/spacer
e Keywords—spacer; metered dose inhaler; MDI; asthma;
followed by placebo nebulization. The nebulizer group (n ؍
nebulizer; emergency department; inner city
29) received placebo by MDI/spacer followed by albuterol
nebulization. Peak flows, symptom scores, and need for
rescue bronchodilatator were monitored. Median values

were compared with the Kolmogorov-Smirnov test. Re-
sults: Patients in the two randomized groups had similar

Asthma affects approximately 14 million adult Ameri- baseline characteristics. The severity of asthma exacerba-
tion, median peak flows, and symptom scores were not

cans and accounts for more than 450,000 hospitalizations significantly different between the two groups. The median
annually. Approximately 1.8 million asthma patients re- (interquartile range) improvement in peak flow was 120
quire emergency department (ED) visits each year. Rates (75–180) L/min vs. 120 (80 –155) L/min in the spacer and
of hospitalizations and ED visits related to asthma aregreatest in the Northeast, especially in New York City.
This study was funded by a grant from Thayer Medical Among New York City’s five boroughs, the two eco- nomically depressed areas of the Bronx and Brooklyn RECEIVED: 2 October 2007; FINAL SUBMISSION RECEIVED: 30 May 2008;ACCEPTED: 22 June 2008 ARTICLE IN PRESS
boroughs had the highest hospitalization rates of 75 and tient settings. Although some have been done in the ED 52 per 10,000, respectively. Economically disadvantaged setting, to our knowledge, none has focused on an inner- inner-city adults, particularly the African-American and city adult patient population who most frequently use the Hispanic populations, are more susceptible The ED as a primary source of asthma care.
ethnic differences in prevalence, morbidity, and mortal- We hypothesized that albuterol delivered with a dis- ity, along with frequent hospitalizations and ED visits, posable spacer would be an efficient, cost-effective al- are highly correlated with poverty and inadequate access ternative to nebulized albuterol treatment for inner-city to medical care. Other factors that may play a role adult asthma patients presenting to the ED.
include urban air quality, indoor allergens, scarcity ofpatient education programs that are culturally and lin-guistically appropriate, and lack of self-management Because the inner-city patient population tends to The study was approved by the Committee of Clinical frequently use the ED rather than a primary physician as Investigations. It was conducted as a prospective, ran- the primary source of asthma care, management strate- domized, double-blinded, placebo-controlled trial in gies in the ED should be appropriately designed, with the adult patients with acute asthma presenting to the EDs of clinical effectiveness, efficiency, and economics being two acute-care inner-city teaching hospitals (total ED taken into consideration Patients with acute asthma visits approximately 88,000/year) in the borough of the are usually treated with nebulized albuterol in the ED and in the inpatient setting after admission. An albuterolmetered dose inhaler (MDI) with a spacer can be usedalternatively, allowing the patient to inhale aerosol from the MDI without the need to coordinate the actuation ofMDI and inhalation, a step many patients have difficulty Patients who presented to the ED with acute exacerba- tion of asthma as defined in the NAEPP (National The MDI/spacer combination has been evaluated in Asthma Education and Prevention Program) Expert adults with mild, moderate, and severe acute asthma in Panel Report II were eligible to participate in the study if various settings, including the outpatient department, they met the following criteria: 1) diagnosis of asthma, 2) inpatient ward, ED, and intensive care settings age 18 –70 years, and 3) ability to perform peak flow Although greater bronchodilatator response might be ex- maneuvers with good effort Patients were excluded pected with a nebulizer due to the higher dose used for for any of the following reasons: 1) requiring intubation nebulization compared with standard measured-dose in- and mechanical ventilation, 2) smoking history Ͼ 20 halers, studies comparing delivery of beta agonist with pack years, and 3) the presence of coexistent systemic MDI plus a spacer vs. a nebulizer show no difference diseases such as congestive heart failure, pulmonary with respect to clinical response in acute severe asthma disease other than asthma such as pneumonia, tubercu- and stable chronic asthma In addition, extra- losis, bronchiectasis, interstitial lung disease, sarcoid- pulmonary sympathetic effects such as tremor, anxiety, osis, pleural diseases, kyphoscoliosis, chronic obstruc- and dysrhythmias were found in one study to be more tive pulmonary disease, renal failure, or cancer.
prevalent in patients receiving nebulized medication All patients who met the eligibility criteria and signed compared to MDI/spacer-delivered medication Al- the informed written consent were enrolled.
buterol administered by a spacer and MDI, therefore, isan effective alternative to a nebulizer Despite the demonstrated equivalency, rapid delivery, and lesser use of personnel resources with the MDI/spacer combination, nebulized albuterol remains the Patients were recruited for the study from August 2004 standard therapy for patients with acute asthma to August 2005 and were randomly assigned to the study Patients’ perception of the nebulizer being more effec- group (MDI/disposable spacer combination) or control tive, the lack of coordination between MDI actuation and group (Nebulizer). Patients were enrolled 24 h a day by inhalation when using an MDI/spacer during acute either the investigators or housestaff specifically trained asthma, especially for first time users, and the notion that by the investigators, who were responsible for maintain- delivery with non-disposable commercial spacers is ing the study records. Randomization codes were se- more expensive, has limited the use of spacers in the ED.
lected by a pharmacist who was not involved in the Most studies comparing the two modes of delivery in study, using a randomization table with a block size of adults have been conducted in the ambulatory and inpa- four. Codes for the study groups were known only to the ARTICLE IN PRESS
pharmacist. All personnel involved in patient recruitment decreasing score indicated improvement. Both groups and medication delivery were blinded to the randomiza- were followed for their expiratory peak flow, symptom tion. A disposable and collapsible, dual-valve holding severity, and the number of rescue bronchodilatator treat- chamber for use with MDI LiteAire (Thayer Medical, ments every hour for a maximum of 6 h. The triage Tucson, AZ) was utilized for the study. Placebo MDIs decision to admit or discharge a patient from the ED was were prepared by a pharmacist who was not involved in made within 6 h of enrollment into the study, and the the study or in the assignment of randomization codes.
study was terminated once the patient was discharged All patients received treatment with the MDI/spacer home or admitted to the hospital. Patients were dis- combination and nebulizer. The MDI/spacer group re- charged home after ED treatment based on the improve- ceived 540 ␮g of chloroflourocarbon (CFC) albuterol by ment in the underlying disease severity as assessed by MDI (six actuations of 90 ␮g/actuation; Warwick Phar- the peak flow. The discharge criterion was peak flow maceutical Corporation, Reno, NV) with the spacer fol- rates Ͼ 70% predicted Patients were discharged home lowed by 3 mL of normal saline solution (0.9%) by with specific therapy based on NAEPP guidelines nebulizer every hour until disposition. The Nebulizergroup received six actuations of placebo MDI withspacer followed by 2.5 mg (3 cc) albuterol (Dey, Napa, CA) by nebulizer (Cardinal Health Edison, NJ) on asimilar schedule. MDI was shaken before each actuation The primary outcomes measured were changes in pa- and medication was administered one actuation at a time tients’ symptoms and peak flow rates, and disposition into the spacer. Each actuation was delivered just before (i.e., admission to hospital or discharge to home from the inhalation and the aerosol was inhaled from the spacer by ED). Secondary outcome measures were length of stay in six tidal breaths. All MDI/spacer treatments were self the ED, cost of therapy, and the number of rescue treat- administered by the patient after a one-time demonstra- ments required. The length of stay was calculated from tion of its use by a respiratory therapist (RT). All nebu- the time of enrollment into the study until the time the lizer treatments were administered by a RT in the asthma decision was made regarding the patient’s disposition. In treatment room in the ED. The RT documented in the the case of patients whose stay in the ED was prolonged electronic medical chart the vital signs, room air oxygen for reasons other than medical, the time of disposition saturation, lung examination, and a pre- and post-treat- was taken as the time they met the criteria for admission ment peak flow rate for every treatment administered.
to the medical ward or discharge home. Cost analysis for The RT managing the patient care was supervised by the each group included the cost of medication, equipment emergency physician on duty. Patients also received (spacer vs. nebulizer kit), and labor (time spent by the rescue treatments with albuterol nebulization as required.
respiratory therapists, for the active medication only).
The cost of placebo medication, the device to deliver Oral or intravenous steroids were administered at the placebo, and the labor to administer it were excluded discretion of the emergency physician.
A baseline peak flow measured by a Wright peak flow meter and a “symptom severity score” were recorded foreach patient at the start of the study, and every hour until disposition. Based on each patient’s perception of sever-ity of symptoms, a score of 0 –3 was assigned, each for Insofar as we did not have an a priori estimate of an shortness of breath, chest tightness, wheezing, and cough effect size difference with which to project a sample size, (0 for none, 1 for mild, 2 for moderate, 3 for severe), and we undertook to enroll as many eligible consecutive a total score was calculated as the sum of each individual participants as possible within the 1-year enrollment period for the study. Entry characteristics between the score reflected a greater severity of symptoms and a two treatment groups were compared to assess whetherthe randomization achieved a reasonable balance. p Val-ues are provided as a guide to this assessment with theunderstanding that the formal interpretation of p is notapplicable to random assignment. Categorical variablesare presented as percentages and compared with chi-squared. Continuous variables within each of the studygroups did not meet normality assumptions. Values arepresented as median (interquartile range [IQR]) and Figure 1. Symptom severity score.
between-group comparisons made with the non-parametric ARTICLE IN PRESS
Table 1. Baseline Characteristics
* Analysis of continuous variables (presented as median and interquartile range) by the non-parametric Kolmogorov-Smirnov test andcategorical variables (presented as % by chi-square). Treatment group was by random allocation, so that both groups came from thesame population. Thus, p values have been given only as a convenient gauge of the effectiveness of the randomization and should notto be given a formal interpretation.
Kolmogorov-Smirnov test. Normality assumptions were the Nebulizer group (97% vs. 93%, respectively) were met sufficiently for the sample as a whole to allow linear discharged home at the completion of the study regression models to assess potential confounding. All Medians (IQR) for increase in peak flow from entry to tests used a two-tailed alpha of 0.05 for statistical sig- disposition were similar for the two groups, with 120 nificance, and analyses were performed with SPSS for (75–180) L/min for the MDI/spacer group and 120 (80 – Windows software (version 13; SPSS Inc., Chicago, IL).
155) L/min for the Nebulizer group (p ϭ 0.56) Symptom severity scores were also similar (p ϭ 0.78).
At least one rescue bronchodilatator treatment was nec- essary for 24% of the MDI/spacer group, compared to21% of the Nebulizer group (p ϭ 0.75). The median We screened 75 patients who presented to our adult ED length of ED stay was 2 h for both groups, with an IQR for an asthma exacerbation. Of 75 patients screened, 5 of 1.5–3.0 h for the MDI/spacer group and an IQR of did not satisfy eligibility criteria and 10 did not giveconsent for participation in the research. The remaining60 patients were randomized into two study groups, 30 in Table 2. Outcomes by Treatment Group
each group. One patient from each group was not in-cluded in the outcome analysis because one withdrew consent and the other signed out against medical advice,leaving 29 per group for the study sample. Entry char- acteristics for the two randomized treatment groups were similar in terms of race, intubation history, asthma du- ration Ͼ 10 years, steroid administration, peak flow rate, and symptom severity score Of the patients enrolled, 48% were Hispanic and 49% were African- American. Smoking history was not significantly differ- ent between the two groups. The MDI/spacer group had a higher percentage of female patients and was at a Disposition (discharged home or admitted to hospital) * Peak flow rate increase, symptom severity decrease, and was similar between the groups (p ϭ 0.55). One patient length of stay in ED are presented as median (interquartile range) in the MDI/spacer group and 2 in the Nebulizer group and compared with the non-parametric Kolmogorov-Smirnovtest. Disposition and receiving rescue treatments are presented were admitted to the hospital (3% vs. 7%, respectively), whereas 28 patients in the MDI/spacer group and 27 in ARTICLE IN PRESS
Table 3. Costs by Treatment Group
* Median (interquartile range). p Values calculated with the non-parametric Kolmogorov-Smirnov test except for delivery system, whichwas constant for both groups, and thus a p value is not applicable.
1–2.5 h for the Nebulizer group (p ϭ 0.78). Adjusting for MDI/spacer combination compared to those treated us- age and gender did not meaningfully change the results.
ing a standard nebulizer delivery system. Although the In post hoc power analysis, with 29 participants per spacer group tended to be female and older, neither sex group, there was 95% power to detect if the MDI/spacer nor age was significantly associated with any of the was Ͼ 50% less effective than the nebulizer for increas- outcome measures. Our results are comparable to a num- ing peak flow rate, and 43% power to detect if the ber of prior studies that revealed equivalent performance MDI/spacer was 25% less effective. Similarly, there was Ͼ 99% and 59% power, respectively, with regard to In 2005, the American College of Chest Physicians/ decrease in symptom severity scores.
American College of Asthma, Allergy, and Immunology The cost analysis for the two groups is summarized in published evidence-based guidelines regarding device Our cost calculations were based only on treat- selection and outcomes of aerosol therapy in various ments with albuterol in each arm and did not include clinical settings based on a meta-analysis of 59 random- placebo administration. Payroll costs (including fringe ized controlled trials (RCT) Of the 19 RCTs that benefits) for a respiratory therapist in our institutions is compared aerosol delivery devices in the ED, the nine on average $40.94 per hour. The RT needed about 10 studies that compared ␤ -agonist delivery by nebulizer to min to instruct and demonstrate the use of an MDI/spacer that by an MDI with a spacer/holding chamber in adult to a patient, just once for the entire ED stay. For the patients with acute asthma did not report a significant Nebulizer group, it required an average of approximately12 min per treatment. Thus, the cost for the RT time difference in pulmonary function response to the two represents the biggest difference in costs between the methods of delivery. Only two of the nine studies re- two groups, with a constant $6.82 per patient in the ported any significant differences between the two MDI/spacer group and a median of $16.38 (IQR 8.19 – groups for time spent in the ED, hospital admission rate, 20.48) for the Nebulizer group (p Ͻ 0.001). There was a and frequency of ED discharge at 6 h.
one-time cost per patient for the delivery system of $2.95 A Cochrane Database meta-analysis updated in 2006 for the LiteAire Spacer and $1.50 for the nebulizer.
by Cates et al. assessed the effects of spacers compared Per-treatment costs of the medication were $0.17 and to nebulizers for the delivery of beta agonists for acute $0.19 for MDI/spacer and nebulizer, respectively. Total asthma The updated review now includes data from costs were significantly lower (p Ͻ .001) for the MDI/ 614 adults randomized in 25 trials from the ED and spacer group, with a median of $10.11 (IQR 10.03– community settings in addition to the inpatient trials. The 10.28) compared to $18.26 (IQR 9.88 –22.45) for the outcomes measured in the trials include hospital admis- sion rates, length of stay in the ED, respiratory and pulserates, blood gases, and lung function. In this meta-analysis,the delivery of beta agonists using a spacer did not seem DISCUSSION
to affect hospital admission rates for adults when com-pared to beta agonist delivery using a nebulizer, with the In this study, we demonstrated that beta-agonist delivery relative risk of admission for spacer vs. nebulizer being with MDI/spacer and nebulizer have equivalent efficacy 0.97 (95% confidence interval 0.63–1.49). The length of for adult patients with mild to moderate asthma exacer- stay in the ED, peak flow rate, and forced expiratory bation in two inner-city EDs. We found no meaningful volume were also similar for the two delivery methods.
differences in number of admissions, changes in median Several methodological limitations, including the lack of peak flow rate, median symptom score, number of rescue standardized spacer device, beta-agonist dose, and re- bronchodilatator treatments, or length of stay in the ED porting of the data regarding lung function tests in many between those treated with bronchodilatators using the studies, may restrict the generalizability of these results ARTICLE IN PRESS
to patients presenting to the ED with an exacerbation of No adverse side effects were found in any of the The cost analysis in our study that took into account In our literature search, we did not find a validated equipment, medication, and labor costs revealed that asthma severity scoring system for adults. This was there was a significant cost reduction utilizing LiteAire exemplified by a small pilot study that revealed that the Spacer vs. a nebulizer. The largest component of the correlation between wheezing and peak flow was weak savings was related to the difference in the labor costs However, in a prior study, when we studied mul- associated with the two delivery systems. Other studies tiple subjective symptoms, giving each symptom a se- have demonstrated similar differences in the labor costs verity rating, we found a reliable correlation between the between the two modes of treatment. However, when cumulative severity symptom score and peak flow analyzing the labor cost, there is a large variability in the Hence, we chose to utilize the same symptom scoring studies with respect to duration of time spent by the RT system in this study. It is our belief that the scoring system during nebulizer delivery. The reported time ranges from utilized in our study can be used when conducting other 4 to 20 min in different studies In our study, outcome studies, although validation of the scoring system the median time spent by the RT was 12 min. To see the in a larger clinical trial would be desirable.
general applicability of this study from a cost perspec- For patients who have poor coordination between tive, we looked at the cost of other currently commer- actuation of MDI and inhalation, spacer use is particu- cially available spacers. The hospital price range for larly valuable because it usually requires only a brief other spacers is between $5.23 and $12.00, a two- to demonstration of the proper use of a MDI/spacer device four-fold difference from the spacer device utilized in to improve user skills In our study, patients this study. The cost of other commercially available found it easy to learn to use the spacer device regardless spacer devices, therefore, would seem to counterbalance of educational background and socioeconomic status.
the savings derived from the labor economics. Because The compact spacer we utilized is made of collapsible the spacer cost in our study is not markedly different cardboard that can be used for up to 1 week. Drug from the thrifty nebulizer cost, the difference between delivery using the LiteAire device has been shown to be the two groups remains significant. An additional factor equivalent to other valved holding chambers like the of economic significance could be the use of CFC albu- Aerochamber Plus® (Forest Pharmaceuticals Inc., St.
terol MDI in our study as opposed to the hydroflouroal- kane (HFA) albuterol. Effective December 2008, the USFood and Drug Administration (FDA) has mandated theuse of HFA albuterol only. Of note is that, unlike a significant difference in the cost of HFA albuterol vs.
CFC albuterol in ambulatory and inpatient settings, the A major limitation to our study was the relatively small current hospital cost for HFA albuterol MDI for patients sample size. Although we had adequate statistical power in the ED is similar to the CFC albuterol. Hence, the new to be confident that the MDI/spacer was not Ͼ 50% less FDA mandate to use HFA albuterol has no significant effective than the nebulizer to increase peak flow rate or cost implications. Our findings are parallel to other stud- decrease symptom severity score, the statistical power ies that have compared MDI/spacers to nebulizer therapy was not sufficient to have similar confidence with regard and demonstrated a cost benefit to MDI/spacers to smaller differences. Nonetheless, the point estimates of the median values for peak flow rate increase, severity There is a wide variation in the bronchodilatator dose of symptoms score, and length of stay in the ED were (1:1 to 1:12.5) reported in the literature in studies com- exactly the same for both groups. Furthermore, one pa- paring the two modes of delivery in the ED setting tient in the MDI/spacer group needed hospitalization, Also, potential dose-related adverse effects of beta ago- compared to 2 patients in the Nebulizer group.
nists have been reported in studies comparing the use of Another limitation is that the majority of patients had nebulizers to MDIs in asthma patients. Extra-pulmonary mild to moderate severity of asthma exacerbation be- sympathetic effects such as tremor, anxiety, and tachy- cause the study recruitment was mostly limited to pa- cardia have been found to be more prevalent in patients tients managed by a respiratory therapist, whereas those receiving nebulized medication compared to MDI/spacer- who were in status asthmaticus were managed by the delivered medication The choice of the bron- emergency physicians and excluded from this study. Our chodilatator dose for our study was based on results of study could have been more robust had we collected data previous studies of children and adults demonstrating the on the baseline use of albuterol or spacers, as well as comparability of six actuations of albuterol MDI (540 patient returns to the ED after discharge. Because our ␮g) with spacer to 2.5 mg delivered by nebulizer trial was limited to only 6 h in the ED, and we did not ARTICLE IN PRESS
send the patient home with the spacer or conduct a chamber is equivalent in effectiveness to nebulizer. Chest follow-up post-disposition, we are unable to comment on 9. Jasper AC, Mohsenifar Z, Kahan S, et al. Cost-benefit comparison these clinical outcomes. Future studies should include a of aerosol bronchodilator delivery methods in hospitalized pa- longer follow-up and collection of the aforementioned 10. Jenkins SC, Heaton RW, Fulton TJ, et al. Comparison of domicil- iary nebulized salbutamol and salbutamol from a metered-dose Although larger studies have reported the equivalence inhaler in stable chronic airflow limitation. Chest 1987;91:804 –7.
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1. Why is this topic important?
Asthma exacerbations are costly to manage. In addi- tion to therapies that increase asthma control and reduce
the frequency or severity of exacerbations, other efforts
to decrease cost may bring economic benefits. Inner-city
patients frequently use the emergency department (ED)
for asthma exacerbations. This study presents data on the
use of a metered dose inhaler with spacer as a cost-
effective alternative to nebulizer therapy for use in acute
exacerbation of asthma in an inner-city ED. Hence, an
alternate mode of B- agonist delivery may reduce the
number of ED visits. Although nebulizer use for bron-
chodilatator delivery in asthma exacerbation requires
longer delivery times and greater resource utilization,
their use is the standard of care due to the expense of
commercially available spacer devices, which would oth-
erwise be a viable alternative. This study presents data on
the use of MDI with spacer as an efficient, cost-effective
alternative to nebulizer for use in acute exacerbation of
asthma in the inner-city population.
2. What does this study attempt to show?
This study attempts to demonstrate that albuterol de- livered with spacer is an efficient, cost-effective alterna-
tive to nebulized albuterol treatment for asthma patients
in the ED in an inner-city hospital.
3. What are the key findings?
Albuterol delivery using the nebulizer or spacer in patients with acute asthma exacerbation resulted in
equivalent improvements in peak expiratory flows and
asthma symptoms in patients, in this randomized, double-
blinded, placebo-controlled trial. The number of rescue
treatments required in the two groups and the length of
ED stay were also equivalent .The cost was significantly
less for the spacer device. Most of the cost benefit was
derived by the amount of time the respiratory therapist
spent with the patient.
4. How is patient care impacted?
This study demonstrates that use of spacer devices may decrease the economic burden of asthma managementwithout compromising the quality of care delivered in aninner-city patient population who frequently use the EDfor managing their asthma.


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