NCT00588406

Brief Summary

To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve forced expiratory volume at one second (FEV1) and decrease the need for hospitalization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Sep 2007

Typical duration for phase_3 asthma

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

January 21, 2016

Completed
Last Updated

January 21, 2016

Status Verified

December 1, 2015

Enrollment Period

2.3 years

First QC Date

December 21, 2007

Results QC Date

October 12, 2015

Last Update Submit

December 15, 2015

Conditions

Asthma

Keywords

acute, emergency department

Outcome Measures

Primary Outcomes (1)

  • FEV1 Percent Predicted

    4 hours post-randomization

Secondary Outcomes (1)

  • Hospitalization

    6 hours

Study Arms (2)

B

EXPERIMENTAL

Budesonide, 2mg, 4 doses, plus standard care

Drug: BudesonideDrug: albuterolDrug: Ipratropium bromideDrug: Prednisone

P

PLACEBO COMPARATOR

Placebo plus standard care

Drug: albuterolDrug: Ipratropium bromideDrug: Prednisone

Interventions

BudesonideDRUG

2mg/dose by nebulizer, four doses over 3 hours

Also known as: Pulmicort Respules
B
albuterolDRUG

2.5mg/dose by nebulizer, 7 doses over 6 hours

Also known as: proventil, proair, ventolin, salbutamol
BP
Ipratropium bromideDRUG

2.5 mg, one dose

Also known as: Atrovent
BP
PrednisoneDRUG

60mg PO

Also known as: deltasone
BP

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • FEV1\<50% predicted after bronchodilator therapy, age 18-60, presenting to an emergency department with acute asthma

You may not qualify if:

  • other chronic lung disease, \>15 pack years smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nassau University Medical Center

East Meadow, New York, 11554, United States

Location

Long Island Jewish Medical Center

Queens, New York, 11042, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

AsthmaEmergencies

Interventions

BudesonideAlbuterolProcaterolIpratropiumPrednisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesHydroxyquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingPregnadienediolsPregnadienes

Results Point of Contact

Title
Dr. Robert Silverman
Organization
North Shore Long Island Jewish Health System
rsilverman@nshs.edu
718-470-7501

Study Officials

  • Robert Silverman, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 8, 2008

Study Start

September 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 21, 2016

Results First Posted

January 21, 2016

Record last verified: 2015-12

Locations

US(3)