Breath Actuated Nebulizer Study Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00382447
Recruitment Status : Withdrawn (Unable to put forth the human resources for patient enrollment)
First Posted : September 29, 2006
Last Update Posted : December 13, 2012
Information provided by (Responsible Party):
Christiana Care Health Services

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Chronic Obstructive Pulmonary Disease Device: standard nebulizer Device: breath actuated nebulizer Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Breath Actuated Nebulizer Study Protocol
Study Start Date : October 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Forced vital capacity [ Time Frame: 1 ]
  2. FEV1 [ Time Frame: 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Christiana Care Health Services Identifier: NCT00382447     History of Changes
Other Study ID Numbers: CCC# 26168
First Posted: September 29, 2006    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012

Keywords provided by Christiana Care Health Services:
breath actuated nebulizer

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases