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Management of Acute Asthma with Nebulized Budesonide: Observational Pilot Study

Clinical and flowmetric response in patients with asthma exacerbations treated with nebulized budesonide

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12610000150044
Enrollment
100
Registered
2010-02-15
Start date
2009-01-15
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Introduction.- Although the effect of nebulized corticosteroid is still deemed controversial, because the available data are scarce and heterogeneous, there is a favorable trend towards the use of this route of administration under different clinical conditions, such as acute asthma, in the Emergency Department, hospitalization, and post-hospital discharge evolution. The primary purpose of this trial is to assess the benefit of nebulized budesonide in acute asthma, in terms of flowmetric and clinical improvement. Methods.- 127 patients were selected from the population with acute asthma who attended several Emergency centers in the city of Lima during the period January-August 2009. This was an observational and paired design in the same participating subject (before-after). With the consensus of the participating doctors, we established an assessment form model to record the clinical and flowmeter data to be used in the subsequent data analysis. So, we assessed two primary outcomes: the Peak Expiratory Flow (PEF) and the use of accesory muscles for ventilation. Ther former was evaluated with a Mini-Wright flowmeter and the last with a clinical score (absent or mild, moderate and severe). Results.- 127 patients were enrolled by means of a non-probabilistic and consecutive sampling. The average age was 15.6 years (5-72 years of age). The average percentage improvement of the peak expiratory flow (PEF), calculated by the formula: initial %PEF - final %PEF, was nearly 20% (p<0.001); in other words, the PEF-observed/PEF-predicted ratio registered a mean increase of 20% with respect to the initial value. The participants were classified by age and flowmetric severity. In participants <12 years of age, the average percentage increase of the PEF-obs/PEF-pred ratio was significantly greater as compared to the group >12 years of age: 23.7%, (IC95: 20.5, 26.9) versus 14.1% (IC95: 11.1, 17.0), p=0.0001. Nevertheless, the start time of the attack (in hours) was significantly greater in those participants >12 years of age (27 h vs. 12 h, p=0001). The non-parametric univariate analysis did not find a statistically significant difference between the three severity groups. Discussion.- The flowmetric improvement achieved with the use of nebulized budesonide was clinically significant, considering the reduction in severe and moderate cases, associated with an increase in normal and mild cases. Although we found a better flowmetric response in those patients <12 years of age, the start time of the attack (greater in those participants >12 years of age) had a significant influence on the magnitude of the response to the nebulized corticosteroid. Likewise, although the flowmetric response was better in the moderate and severe severity groups, this difference did not reach statistic significance, suggesting that all patients would respond to the treatment in a similar way. Conclusion.- The results suggest a positive response to nebulizad budesonide for child or adult patients with acute asthma. Nevertheless, it is necessary to have a greater number of controlled clinical trials, with similar designs, for a better estimation of the effect.

Interventions

Nebulized budesonide: 1-2 mg in each nebulization according to the exacerbation severity (only for 2 nebulizations), added to fenoterol nebulization (in standard dose). The trial was developed during 5 months.

Sponsors

Rafael Bolanos
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

children and adults with asthma exacerbation

Exclusion criteria

patients with very severe asthma exacerbation or patients who had received any systemic corticosteroid.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026