Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

Phase 2

Completed

• Conditions: Asthma
• Interventions: Device: Human-Powered Nebulizer

• Registration Number: NCT01795742
• Lead Sponsor: Marquette University

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.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-02
• Study First Submitted: 2013-02-03
• Study First Submitted QC: 2013-02-18
• Last Update Submitted: 2013-02-18
• Study First Posted: 2013-02-21
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human-Powered Nebulizer	Human-Powered Nebulizer	Human-Powered
Electric Nebulizer	Human-Powered Nebulizer	Pulmo-Aide Model 5650D

Primary Outcome Measures

Name	Time	Method
Improvement in Peak Expiratory Flow	From before to after nebulizer treatment lasting approximately 30 minutes

Secondary Outcome Measures

Name	Time	Method
Improvement in blood oxygenation as measured by pulse oximetry	From before to after nebulizer treatment lasting about 30 minutes

Trial Locations

Locations (1)

Hospital Nacional San Bartolo; 🇸🇻 Ilopango, San Salvador, El Salvador