Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000150044
Ethics application status
Approved
Date submitted
5/02/2010
Date registered
15/02/2010
Date last updated
15/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Management of Acute Asthma with Nebulized Budesonide: Observational Pilot Study
Scientific title
Clinical and flowmetric response in patients with asthma exacerbations treated with nebulized budesonide
Secondary ID [1] 1401 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma exacerbations 256760 0
Condition category
Condition code
Respiratory 256910 256910 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 255972 0
Not applicable
Comparator / control treatment
No comparator used. Patients were nebulized with fenoterol and budesonide, together in the same nebulization device.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257786 0
Peak Expiratory Flow.- Values obtained with a flowmeter device.

Use of accesory mucles.- clinical assessment by Pediatrician. Clinical score with 3 categories: absent or mild, moderate or severe.
Timepoint [1] 257786 0
1 or 2 hours after the last nebulization
Secondary outcome [1] 263187 0
none
Timepoint [1] 263187 0
none

Eligibility
Key inclusion criteria
children and adults with asthma exacerbation
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with very severe asthma exacerbation or patients who had received any systemic corticosteroid.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2468 0
Peru
State/province [1] 2468 0

Funding & Sponsors
Funding source category [1] 256472 0
Self funded/Unfunded
Name [1] 256472 0
Rafael Bolanos
Country [1] 256472 0
Peru
Primary sponsor type
Individual
Name
Rafael Bolanos
Address
Morelli 139, Office 203, San Borja (Lima 41), Lima, Peru.
Country
Peru
Secondary sponsor category [1] 255780 0
None
Name [1] 255780 0
none
Address [1] 255780 0
none
Country [1] 255780 0
Peru

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30807 0
Address 30807 0
Country 30807 0
Phone 30807 0
Fax 30807 0
Email 30807 0
Contact person for public queries
Name 14054 0
Rafael Bolanos
Address 14054 0
Morelli 139, Office 203, San Borja (Lima 41), Lima, Peru.
Country 14054 0
Peru
Phone 14054 0
511-2126025
Fax 14054 0
Email 14054 0
rafael.bolanos@farma.com.ve
Contact person for scientific queries
Name 4982 0
Rafael Bolanos
Address 4982 0
Morelli 139, Office 203, San Borja (Lima 41), Lima, Peru.
Country 4982 0
Peru
Phone 4982 0
511-2126025
Fax 4982 0
Email 4982 0
rafael.bolanos@farma.com.ve

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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