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Completed

NCT Number: NCT01795742

Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Nacional San Bartolo

Ilopango, San Salvador Department, El Salvador

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human-Powered Nebulizer

Device

Primary outcomes

  1. Improvement in Peak Expiratory Flow

    Time frame: From before to after nebulizer treatment lasting approximately 30 minutes

Secondary outcomes

  1. Improvement in blood oxygenation as measured by pulse oximetry

    Time frame: From before to after nebulizer treatment lasting about 30 minutes

Sponsors and collaborators

Lead sponsor

Marquette University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 21, 2013
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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