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Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer in the Treatment of Mild to Moderate Asthma in El Salvador

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01795742
Enrollment
110
Registered
2013-02-21
Start date
2012-08-31
Completion date
2012-10-31
Last updated
2013-02-21

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

Conditions

Asthma

Keywords

Asthma, Nebulizers, Salbutamol, Developing Countries

Brief summary

This is an equivalence study comparing an electric nebulizer with a human-powered nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma exacerbations in a regional clinic in San Salvador, El Salvador.

Detailed description

The study design is to treat individuals suffering from mild to moderate exacerbations of asthma with nebulized salbutamol (2.5mg). Subjects will receive nebulization using either an electric nebulizer compressor or a human-powered nebulizer compressor. Improvement in peak expiratory flow will be the primary endpoint. Blood oxygenation levels as measured by pulse oximetry will be a secondary endpoint of the trial.

Interventions

DEVICEHuman-Powered Nebulizer

Sponsors

Marquette University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Suffering from Mild or Moderate Asthma symptoms * Increased respiratory rate, but not over 30 breaths per minute * Reduced peak expiratory flow rate, but not less than 60% of normal * Oxygen saturation levels reduced but greater than 90%

Exclusion criteria

* Any other respiratory condition that would interfere with nebulizer treatment * If any other medication is being taken at the time * Pregnant women or women who may think they might be pregnant * Never taken salbutamol before

Design outcomes

Primary

MeasureTime frame
Improvement in Peak Expiratory FlowFrom before to after nebulizer treatment lasting approximately 30 minutes

Secondary

MeasureTime frame
Improvement in blood oxygenation as measured by pulse oximetryFrom before to after nebulizer treatment lasting about 30 minutes

Countries

El Salvador

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026