Breath Actuated Nebulizer Study Protocol

This study has been withdrawn prior to enrollment.
(Unable to put forth the human resources for patient enrollment)
Information provided by (Responsible Party):
Christiana Care Health Services Identifier:
First received: September 27, 2006
Last updated: December 12, 2012
Last verified: December 2012

Comparison of the researchers' standard nebulizer and a breath actuated nebulizer to examine if breathing medication can be delivered more quickly and as effectively or more effectively than the standard nebulizer.

Condition Intervention
Chronic Obstructive Pulmonary Disease
Device: standard nebulizer
Device: breath actuated nebulizer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Breath Actuated Nebulizer Study Protocol

Resource links provided by NLM:

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Forced vital capacity [ Time Frame: 1 ] [ Designated as safety issue: Yes ]
  • FEV1 [ Time Frame: 1 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: October 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Standard nebulizer versus standard breath actuated nebulizer
Device: standard nebulizer
Standard small volume nebulizer for aerosolized medication delivery
Device: breath actuated nebulizer
Nebulizer that dispenses medication only during the inspiratory phase

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients with orders for routine 2.5 mg albuterol sulfate nebulizer therapy ordered either Q4 or Q6 hours who consent to the study.

Exclusion Criteria:

  • Adults with nebulizer therapy ordered more frequently than Q4 hours.
  • Adults with nebulizer therapy ordered less frequently than Q6 hours.
  • Pregnant patients are excluded.
  • Adults with orders for albuterol sulfate > 2.5 mg.
  • Adults in the ICU or Emergency Department.
  Contacts and Locations
Please refer to this study by its identifier: NCT00382447

United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Principal Investigator: John S. Emberger, BS Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Christiana Care Health Services Identifier: NCT00382447     History of Changes
Other Study ID Numbers: CCC# 26168
Study First Received: September 27, 2006
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
breath actuated nebulizer

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on April 17, 2014