Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

February 18, 2013 updated by: Lars Olson, Marquette University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • El Salvador
    • San Salvador
      • Ilopango, San Salvador, El Salvador
        • Hospital Nacional San Bartolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Electric Nebulizer
Pulmo-Aide Model 5650D
Device: Human-Powered Nebulizer
Experimental: Human-Powered Nebulizer
Human-Powered
Device: Human-Powered Nebulizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in Peak Expiratory Flow
Time Frame: From before to after nebulizer treatment lasting approximately 30 minutes
From before to after nebulizer treatment lasting approximately 30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in blood oxygenation as measured by pulse oximetry
Time Frame: From before to after nebulizer treatment lasting about 30 minutes
From before to after nebulizer treatment lasting about 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marquette University

Investigators

  • Principal Investigator: Lars E Olson, Ph.D., Marquette University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 3, 2013

First Submitted That Met QC Criteria

February 18, 2013

First Posted (Estimate)

February 21, 2013

Study Record Updates

Last Update Posted (Estimate)

February 21, 2013

Last Update Submitted That Met QC Criteria

February 18, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-HR-2433

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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