Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795742
• Other study ID #: MU-HR-2433
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2013
• Last updated: February 18, 2013
• Start date: August 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Marquette University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Human-Powered Nebulizer

Locations

Country	Name	City	State
El Salvador	Hospital Nacional San Bartolo	Ilopango	San Salvador

Sponsors (1)

Lead Sponsor	Collaborator
Marquette University

Country where clinical trial is conducted

El Salvador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Peak Expiratory Flow		From before to after nebulizer treatment lasting approximately 30 minutes	No
Secondary	Improvement in blood oxygenation as measured by pulse oximetry		From before to after nebulizer treatment lasting about 30 minutes	No