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Breath Actuated Nebulizer Study Protocol

This study has been withdrawn prior to enrollment.
(Unable to put forth the human resources for patient enrollment)
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00382447
First received: September 27, 2006
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Asthma
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:

U.S. FDA Resources

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00382447

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

No publications provided

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov 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
nebulizer

Additional relevant MeSH terms:
Asthma
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
 Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013