Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

Marquette University

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Device: Human-Powered Nebulizer

Study type: Interventional

Funder types: Other

Identifiers

NCT01795742

MU-HR-2433

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 6 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Electric Nebulizer

Active Comparator group

Description:

Pulmo-Aide Model 5650D

Treatment:

Device: Human-Powered Nebulizer

Human-Powered Nebulizer

Experimental group

Description:

Human-Powered

Treatment:

Device: Human-Powered Nebulizer