Is there any data showing a clinical benefit of MDI inhalers over nebulizers, or vice-versa, in pediatric patients?

Comment by InpharmD Researcher

Limited data from meta-analyses and randomized controlled trials (RCTs) supports the clinical benefit of metered-dose inhalers (MDIs) compared to nebulizers, particularly when used with a valved holding chamber (VHC) in pediatric patients with acute asthma exacerbations. MDIs were associated with reduced hospital admissions, improved clinical scores, greater reductions in pulmonary index scores (PIS), and fewer adverse events such as elevated heart rate and vomiting. Additionally, a cost-effectiveness analysis indicated that MDIs may be a more economically favorable option, particularly in resource-limited settings, while maintaining or exceeding the clinical efficacy of nebulizers. Notably, no evidence favored nebulizers over MDIs across the reviewed studies.

Background

A 2024 systematic review and meta-analysis evaluated the comparative effectiveness and safety of albuterol administered via metered-dose inhaler with a spacer (MDI+S) versus nebulization (NEB) in children experiencing acute asthma or wheezing exacerbations. This review included 15 randomized controlled trials (RCTs) encompassing a total of 2,057 pediatric patients managed in either emergency departments or inpatient settings. Eligible studies directly compared albuterol delivery via MDI+S and NEB, with hospital admission identified as the primary outcome. Secondary endpoints included arterial oxygen saturation (SaO₂), heart rate (HR), respiratory rate (RR), Pulmonary Index Score (PIS), adverse events (e.g., tremor, nausea, palpitations), and the need for additional bronchodilator therapy. Hospital admission rates demonstrated no statistically significant difference between MDI+S and NEB delivery methods (RR 0.89; 95% CI, 0.55–1.46; p= 0.65). However, MDI+S was associated with a statistically significant reduction in pulmonary index scores (MD −0.63; 95% CI, −0.91 to −0.35; p<0.00001), indicating better clinical improvement. Moreover, patients receiving albuterol via MDI+S experienced a significantly smaller increase in HR compared to NEB (MD −6.47 bpm; 95% CI, −11.69 to −1.25; I²=0%; p= 0.02), suggesting a more favorable cardiovascular profile. No significant differences were observed for SaO₂, RR, or adverse effects such as tremor, nausea, and palpitations. Although variation in dosing strategies across studies and high risk of unblinded designs in several trials posed limitations, the pooled data support MDI+S as a clinically comparable and potentially safer alternative to NEB in pediatric acute asthma therapy. [1]

A 1997 review systematically evaluated 17 prospective clinical trials, including 10 RCTs, comparing the efficacy of metered-dose inhalers with accessory devices (MDI/ADs) versus small-volume nebulizers (SVNs) in treating acute asthma in pediatric patients. The review included data from 301 children treated with MDI/ADs and 274 with SVNs. Among the comparative studies, 2 demonstrated superior efficacy of MDI/ADs, while 8 showed equivalent clinical outcomes between MDI/ADs and SVNs. No study found SVNs to be superior. Clinical outcomes assessed included pulmonary function tests (e.g., forced expiratory volume in 1 second [FEV₁], peak expiratory flow [PEF]), clinical scores, oxygen saturation, heart rate, and treatment duration. For example, Fuglsang et al. reported significantly greater and longer-lasting improvement in FEV₁ with MDI/AD (78% vs 56% improvement, respectively). Lin et al. found greater percentage increases in FEV₁, PEF, and SaO₂ with MDI/ADs. Chou et al. reported shorter mean emergency department treatment times for MDI/ADs (66 minutes) compared to SVNs (103 minutes; p<0.001). Adverse effects were similar or less frequent in MDI/AD groups, with SVN groups sometimes showing more vomiting and higher heart rates. Based on these findings, the authors concluded that MDI/ADs are effective and should be considered the preferred first-line treatment in acute pediatric asthma due to comparable or superior clinical efficacy, reduced cost, faster administration, and lower personnel demands. [2]

A 2004 meta-analysis evaluated the clinical efficacy of β-agonists delivered via MDI with valved holding chamber (VHC) versus nebulizer in children under 5 years of age presenting to emergency departments with acute wheezing or asthma exacerbations. Six RCTs comprising 491 patients were included. The primary outcome—hospital admission—was significantly lower in the MDI+VHC group (odds ratio [OR] 0.42; 95% CI 0.24 to 0.72; p= 0.002), with a number needed to treat (NNT) of 10 (95% CI 6 to 26). This benefit was more pronounced in children with moderate to severe exacerbations (OR 0.27; 95% CI 0.13 to 0.54; p= 0.0003). Secondary outcome analysis revealed a significantly greater improvement in clinical severity scores in the MDI+VHC group compared to nebulizer (standardized mean difference [SMD] −0.44; 95% CI −0.68 to −0.20; p= 0.0003). Subgroup analyses confirmed robustness across study quality and patient subgroups. No significant differences in oxygen saturation were observed, while increased heart rate and respiratory rate were more frequently reported in nebulizer groups in individual studies. Overall, this meta-analysis provides explicit data supporting greater clinical benefit of MDI+VHC over nebulizers in reducing hospital admissions and improving clinical scores in this pediatric population. [3]

A 2020 cost-effectiveness analysis evaluated bronchodilator delivery methods in pediatric asthma exacerbations in the emergency department (ED) setting of a middle-income country (MIC). Using a modified decision-analytic model, the analysis compared metered-dose inhalers with spacers (MDI+S) against jet nebulization (NEB) for the delivery of albuterol in children aged 6 months to 18 years presenting with mild to severe asthma exacerbations in Bogotá, Colombia. Effectiveness data, specifically hospitalization rates, ED stay duration, inpatient length of stay, and persistence of asthma symptoms following discharge, were derived from a Cochrane systematic review focused on beta2-agonist delivery modalities in children. Economic inputs, including drug and device costs, healthcare utilization, and hospital-based resources, were obtained from both national healthcare databases (SISMED) and actual hospital billing data from a tertiary pediatric center. The analytical horizon extended to 14 days post-discharge, with primary outcomes centered on avoidance of hospital admission. All costs were standardized to 2018 U.S. dollars. The base-case analysis demonstrated that MDI+S was economically dominant over nebulization, yielding both superior outcomes and reduced cost. Specifically, MDI+S was associated with a higher rate of hospital admission avoidance (0.9219 vs 0.8900) and lower average treatment cost per patient (US$96.68 vs US$121.41). Probabilistic sensitivity analysis using 10,000 Monte Carlo simulations confirmed the robustness of the model, with MDI+S maintaining superiority in 99.9% of iterations. The 95% uncertainty interval for avoidance of hospitalization with MDI+S ranged from 0.9009 to 0.9418, and the corresponding costs ranged from US$73.71 to US$124.62. A cost-effectiveness acceptability curve indicated that MDI+S remained the preferred strategy across all willingness-to-pay thresholds. These findings reinforce the clinical and economic benefits of transitioning from nebulization to MDI+S in resource-limited healthcare systems. [4]

References:

[1] Payares-Salamanca L, Contreras-Arrieta S, Florez-García V, Barrios-Sanjuanelo A, Stand-Niño I, Rodriguez-Martinez CE. Metered-dose inhalers versus nebulization for the delivery of albuterol for acute exacerbations of wheezing or asthma in children: A systematic review with meta-analysis. Pediatr Pulmonol. 2020;55(12):3268-3278. doi:10.1002/ppul.25077
[2] Amirav I, Newhouse MT. Metered-dose inhaler accessory devices in acute asthma: efficacy and comparison with nebulizers: a literature review. Arch Pediatr Adolesc Med. 1997;151(9):876-882. doi:10.1001/archpedi.1997.02170460014003
[3] Castro-Rodriguez JA, Rodrigo GJ. beta-agonists through metered-dose inhaler with valved holding chamber versus nebulizer for acute exacerbation of wheezing or asthma in children under 5 years of age: a systematic review with meta-analysis. J Pediatr. 2004;145(2):172-177. doi:10.1016/j.jpeds.2004.04.007
[4] Rodriguez-Martinez CE, Sossa-Briceño MP, Castro-Rodriguez JA. Metered-dose inhalers vs nebulization for the delivery of albuterol in pediatric asthma exacerbations: A cost-effectiveness analysis in a middle-income country. Pediatr Pulmonol. 2020;55(4):866-873. doi:10.1002/ppul.24650

Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

Is there any data showing a clinical benefit of MDI inhalers over nebulizers, or vice-versa, in pediatric patients?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→



Please see Tables 1-2 for your response.


 

Metered dose inhaler and nebuliser in acute asthma
Design

Randomized controlled trial

N= 111

Objective To compare the delivery of terbutaline by a metered dose inhaler (MDI) with a valved holding chamber versus a nebuliser driven by air in children with acute asthma
Study Groups

MDI group (n= 56)

Nebuliser group (n= 55)

Inclusion Criteria Patients at least 5 years of age, able to perform spirometry, with a diagnosis of acute asthma or acute exacerbation of chronic asthma
Exclusion Criteria Patients with pneumonia, congestive heart failure, foreign body aspiration, bronchopulmonary dysplasia, or who received aerosolised β agonist within six hours before presentation
Methods Patients were randomized to receive either three puffs (0.75 mg) of terbutaline via MDI with a valved holding chamber or 2 ml (5.0 mg) terbutaline solution via nebuliser over 10 minutes. Spirometry, pulse oximetry, and clinical severity scores were measured at baseline and 15 minutes after treatment
Duration Not specified
Outcome Measures

Oxygen saturation (Sao2), spirometry parameters (forced vital capacity [FVC], forced expiratory volume in one second [FEV1], peak expiratory flow [PEF], FEF25-75%), clinical severity score

Baseline Characteristics Characteristic MDI group (n= 56) Nebuliser group (n= 55)
Sex (M/F) 40/16 35/20
Age, years 8.1 ± 2.6 8.4 ± 3.0
FVC, % 74.75 ± 24.31 71.63 ± 21.24
FEV1, % 65.74 ± 20.33 63.14 ± 20.50
PEF, % 57.56 ± 19.60 60.30 ± 21.32
FEF25-75%, % 57.53 ± 28.02 55.63 ± 28.77
Clinical severity score 4.86 ± 1.80 4.60 ± 1.83
Sao2, % 96.29 ± 1.94 95.91 ± 1.96
Pulse rate, beats/min 110 ± 19 111 ± 20
Results Parameter MDI group Nebuliser group p-value
FVC, % 86.60 ± 24.51 82.02 ± 22.80 NS
FEV1, % 78.80 ± 21.58 71.80 ± 22.08 NS
PEF, % 70.10 ± 21.24 62.79 ± 20.25 NS
FEF25-75%, % 75.24 ± 31.25 63.82 ± 28.83 NS
Clinical severity score 2.27 ± 1.83 2.53 ± 1.93 NS
Sao2, % 96.82 ± 1.63 95.44 ± 1.88 <0.0001
Pulse rate, beats/min 111 ± 17 113 ± 19 NS
Adverse Events Oxygen desaturation was more frequent in the nebuliser group (47%) compared to the MDI group (23%).
Study Author Conclusions Aerosol treatment by MDI with a valved holding chamber is superior to nebuliser treatment in terms of oxygen saturation and some spirometric measurements. Caution is advised when using room air as the driving gas for nebulisation due to the risk of oxygen desaturation.
Critique The study effectively demonstrates the superiority of MDI over nebuliser in certain parameters, but the lack of long-term follow-up and the exclusion of patients with recent β agonist use may limit the generalizability of the findings. Additionally, the study does not address the potential impact of different terbutaline dosages on the outcomes. 
References:

Lin YZ, Hsieh KH. Metered dose inhaler and nebuliser in acute asthma. Arch Dis Child. 1995;72(3):214-218. doi:10.1136/adc.72.3.214

Salbutamol and ipratropium by inhaler is superior to nebulizer in children with severe acute asthma exacerbation: Randomized clinical trial
Design

Randomized clinical trial

N= 103

Objective To compare the efficacy of salbutamol and ipratropium bromide (SIB) by metered-dose inhaler (MDI) versus by nebulizer (NEB) in severe asthma exacerbations
Study Groups

MDI-SIB (n= 52)

NEB-SIB (n= 51)

Inclusion Criteria Children 2-18 years of age with severe acute asthma exacerbation (Pulmonary Score ≥7)
Exclusion Criteria Clinical or radiologic pneumonia; pulmonary and/or cardiac congenital malformations; chronic pulmonary disease; foreign body aspiration; neurological alteration; very severe acute asthma exacerbation with cardiopulmonary failure imminent or mechanical ventilation indication
Methods Children in the MDI-SIB group received two puffs of salbutamol MDI every 10 min for 2 h, then every 30 min for 2 h more, with a valved holding chamber and mask along with oxygen by a cannula. Children in the NEB-SIB group received nebulization of salbutamol every 20 min for 2 h, then every 30 min for 2 h more. Both groups received ipratropium bromide and additional treatments, including methylprednisolone and magnesium sulfate
Duration January 2013 to January 2017
Outcome Measures

Primary: Rate of hospitalization (Pulmonary Score ≥7) after 4 h

Secondary: Oxygen saturation

Baseline Characteristics Characteristic MDI-SIB (n= 52) NEB-SIB (n= 51)
Age (years) 5 [3-9.5] 5 [3-10]
Gender (male) 30 (57%) 27 (52.9%)
Atopy (dermatitis, rhinitis) 16 (30.8%) 18 (35.3%)
Parental asthma 15 (28.8%) 14 (27.5%)
Secondhand tobacco exposure 17 (32.7%) 19 (37.3%)
Asthma diagnosis 16 (30.8%) 17 (33.3%)

Asthma controllers last 3 months

ICS + LABA

ICS

Montelukast

 

17 (32.7%)

16 (30.8%)

17 (32.7%) 

 

18 (35.3%)

14 (27.5%)

16 (41.4%)

Results Endpoint MDI-SIB (n = 52) NEB-SIB (n = 51) p-value
Hospital admission at 4 h 3 (5.76%) 14 (27.45%) 0.003

Oxygen saturation 

Basal

30 min

60 min

90 min

120 min

4 h

 

85.0 ± 1.3

85.3 ± 1.5

87.8 ± 1.3

90.5 ± 1.7

92.8 ± 1.9

95.3 ± 2.0 

 

85.15 ± 0.8

85.4 ± 1.4

87.09 ± 0.8

88.4 ± 1.1

90.0 ± 1.8

91.9 ± 1.9

 

0.59

0.57

0.097

<0.00001

<0.00001

<0.00001

Pulmonary score

Basal

30 min

60 min

90 min

120 min

4 h

 

7.04 ± 0.19

7.04 ± 0.19

4.46 ± 0.7

4.02 ± 0.83

3.32 ± 0.83

2.5 ± 1.0

 

7.06 ± 0.37

7.00 ± 0.28

5.76 ± 0.65

5.08 ± 0.77

4.49 ± 0.73

4.15 ± 0.9

 

0.73

0.42

<0.00001

<0.00001

<0.00001

<0.00001

Heart rate 

Basal

30 min

60 min

90 min

120 min

4 h

 

156.63 ± 1.84

156.76 ± 4.88

159.67 ± 7.29

158.46 ± 8.24

158.34 ± 5.10

144.7692 ± 6.50

 

156.54 ± 1.77

160.17 ± 4.77

166.84 ± 6.67

166.84 ± 6.67

173.05 ± 8.58

172.20 ± 9.52

 

0.8

0.003

<0.00001

<0.00001

<0.00001

<0.00001

Adverse Events Refer to Results
Study Author Conclusions Even in severe asthma exacerbations, administration of salbutamol and ipratropium by MDI with valved-holding chamber and mask along with oxygen by a cannula separately was more effective than by a nebulizer.
InpharmD Researcher Critique The study provides strong evidence for the efficacy of MDI over nebulizer in severe asthma exacerbations, but it lacks follow-up data post-ER discharge and does not include lung function measurements. Additionally, other adverse effects were not evaluated
References:

Iramain R, Castro-Rodriguez JA, Jara A, et al. Salbutamol and ipratropium by inhaler is superior to nebulizer in children with severe acute asthma exacerbation: Randomized clinical trial. Pediatr Pulmonol. 2019;54(4):372-377. doi:10.1002/ppul.24244