Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electric Nebulizer

Pulmo-Aide Model 5650D

Group Type ACTIVE_COMPARATOR

Human-Powered Nebulizer

Intervention Type DEVICE

Human-Powered Nebulizer

Human-Powered

Group Type EXPERIMENTAL

Human-Powered Nebulizer

Intervention Type DEVICE

Interventions

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Human-Powered Nebulizer

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No