ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

asthma exacerbations

Condition category

Condition code

Respiratory

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]

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]

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]

1 or 2 hours after the last nebulization

Secondary outcome [1]

none

Timepoint [1]

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?

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]

Peru

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Rafael Bolanos

Address [1]

Morelli 139, Office 203, San Borja (Lima 41), Lima, Peru.

Country [1]

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]

None

Name [1]

none

Address [1]

none

Country [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Rafael Bolanos

Address

Morelli 139, Office 203, San Borja (Lima 41), Lima, Peru.

Country

Peru

Phone

511-2126025

Fax

rafael.bolanos@farma.com.ve

Contact person for scientific queries

Name

Rafael Bolanos

Address

Morelli 139, Office 203, San Borja (Lima 41), Lima, Peru.

Country

Peru

Phone

511-2126025

Fax

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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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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