NCT00382447

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

December 13, 2012

Status Verified

December 1, 2012

Enrollment Period

1.7 years

First QC Date

September 27, 2006

Last Update Submit

December 12, 2012

Conditions

AsthmaChronic Obstructive Pulmonary Disease

Keywords

breath actuated nebulizernebulizer

Outcome Measures

Primary Outcomes (2)

  • Forced vital capacity

    1

  • FEV1

    1

Study Arms (1)

1

EXPERIMENTAL

Standard nebulizer versus standard breath actuated nebulizer

Device: standard nebulizerDevice: breath actuated nebulizer

Interventions

standard nebulizerDEVICE

Standard small volume nebulizer for aerosolized medication delivery

1
breath actuated nebulizerDEVICE

Nebulizer that dispenses medication only during the inspiratory phase

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John S. Emberger, BS

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2006

First Posted

September 29, 2006

Study Start

October 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

December 13, 2012

Record last verified: 2012-12

Locations

US(1)