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Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

El Salvador

Study Type

Interventional

Intervention

Human-Powered Nebulizer

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Nebulizers, Salbutamol, Developing Countries

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Nacional San Bartolo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Electric Nebulizer

Human-Powered Nebulizer

Arm Description

Pulmo-Aide Model 5650D

Human-Powered

Outcomes

Primary Outcome Measures

Improvement in Peak Expiratory Flow

Secondary Outcome Measures

Improvement in blood oxygenation as measured by pulse oximetry

Full Information

NCT ID

NCT01795742

First Posted

February 3, 2013

Last Updated

February 18, 2013

Sponsor

Marquette University

1. Study Identification

Unique Protocol Identification Number

NCT01795742

Brief Title

Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Marquette University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Nebulizers, Salbutamol, Developing Countries

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electric Nebulizer

Arm Type

Active Comparator

Arm Description

Pulmo-Aide Model 5650D

Arm Title

Human-Powered Nebulizer

Arm Type

Experimental

Arm Description

Human-Powered

Intervention Type

Device

Intervention Name(s)

Human-Powered Nebulizer

Primary Outcome Measure Information:

Title

Improvement in Peak Expiratory Flow

Time Frame

From before to after nebulizer treatment lasting approximately 30 minutes

Secondary Outcome Measure Information:

Title

Improvement in blood oxygenation as measured by pulse oximetry

Time Frame

From before to after nebulizer treatment lasting about 30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars E Olson, Ph.D.

Organizational Affiliation

Marquette University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Nacional San Bartolo

City

Ilopango

State/Province

San Salvador

Country

El Salvador

12. IPD Sharing Statement

Citations:

PubMed Identifier

24965834

Citation

Hallberg CJ, Lysaught MT, Najarro RA, Cea Gil F, Villatoro C, Diaz de Uriarte AC, Olson LE. Treatment of asthma exacerbations with the human-powered nebuliser: a randomised parallel-group clinical trial. NPJ Prim Care Respir Med. 2014 Jun 26;24:14016. doi: 10.1038/npjpcrm.2014.16.

Results Reference

derived

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Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

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