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Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.

Sponsor
Northwell Health (Other)
Overall Status
Completed
CT.gov ID
NCT00588406
Collaborator
AstraZeneca (Industry), Jacobi Medical Center (Other), Nassau University Medical Center (Other)
95
Enrollment
3
Locations
2
Arms
27
Duration (Months)
31.7
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a randomized clinical trial studying the effect of nebulized budesonide (Pulmicort) in acutely ill adults presenting to the Emergency Department with severe asthma. Budesonide is an inhaled steroid FDA approved for the treatment of pediatric chronic asthma. ED entry criteria include hyporesponsiveness to nebulized beta-agonists and an FEV1<50% predicted. The trial will evaluate the efficacy of multiple doses of nebulized budesonide as an adjunct to a highly regimented standardized treatment protocol; standard care consists of bronchodilators (beta-agonists/anticholinergics), systemic steroids, and intravenous magnesium sulfate (if the FEV1<25% predicted). The primary efficacy endpoint will be the FEV1 4 hours after administration of the study intervention. An additional safety and efficacy endpoint will take place at 5 hours after study intervention. The treatments will be coupled with a protocol-defined assessment regimen, with endpoints measured before each treatment and on ED disposition (at 5 hours after study intervention).

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Emergency Department (ED) Use of Nebulized Budesonide as an Adjunct to Standardized Therapy in Acutely Ill Adults With Refractory Asthma: a Randomized, Double-blinded, Placebo-controlled Trial
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: B

Budesonide, 2mg, 4 doses, plus standard care

Drug: Budesonide
2mg/dose by nebulizer, four doses over 3 hours
Other Names:
  • Pulmicort Respules

    • Drug: albuterol
    2.5mg/dose by nebulizer, 7 doses over 6 hours
    Other Names:
  • proventil
  • proair
  • ventolin
  • salbutamol

    • Drug: Ipratropium bromide
    2.5 mg, one dose
    Other Names:
  • Atrovent

    • Drug: Prednisone
    60mg PO
    Other Names:
  • deltasone

    		•
    Placebo Comparator: P

    Placebo plus standard care

    Drug: albuterol
    2.5mg/dose by nebulizer, 7 doses over 6 hours
    Other Names:
  • proventil
  • proair
  • ventolin
  • salbutamol

    • Drug: Ipratropium bromide
    2.5 mg, one dose
    Other Names:
  • Atrovent

    • Drug: Prednisone
    60mg PO
    Other Names:
  • deltasone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. FEV1 Percent Predicted [4 hours post-randomization]

    Secondary Outcome Measures

    1. Hospitalization [6 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • FEV1<50% predicted after bronchodilator therapy, age 18-60, presenting to an emergency department with acute asthma
    Exclusion Criteria:
    • other chronic lung disease, >15 pack years smoking

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jacobi Medical Center Bronx New York United States 10461
    2 Nassau University Medical Center East Meadow New York United States 11554
    3 Long Island Jewish Medical Center Queens New York United States 11042

    Sponsors and Collaborators

    • Northwell Health
    • AstraZeneca
    • Jacobi Medical Center
    • Nassau University Medical Center

    Investigators

    • Principal Investigator: Robert Silverman, MD, Northwell Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert A Silverman, Physician, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT00588406
    Other Study ID Numbers:
    • 07.02.019
    First Posted:
    Jan 8, 2008
    Last Update Posted:
    Jan 21, 2016
    Last Verified:
    Dec 1, 2015
    Keywords provided by Robert A Silverman, Physician, Northwell Health
    acute, emergency department
    Additional relevant MeSH terms:
    Asthma
    Emergencies
    Prednisone
    Budesonide
    Bromides
    Albuterol
    Ipratropium

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Budesonide Placob
    Arm/Group Description Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO
    Period Title: Overall Study
    STARTED 46 49
    COMPLETED 46 49
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Budesonide Placebo Total
    Arm/Group Description Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO Total of all reporting groups
    Overall Participants 46 49 95
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    37.2
    (11.4)
    42.6
    (11.4)
    40
    (11.7)
    Sex: Female, Male (Count of Participants)
    Female
    29
    63%
    22
    44.9%
    51
    53.7%
    Male
    17
    37%
    27
    55.1%
    44
    46.3%
    Race/Ethnicity, Customized (participants) [Number]
    White
    2
    4.3%
    3
    6.1%
    5
    5.3%
    Black
    28
    60.9%
    18
    36.7%
    46
    48.4%
    Hispanic
    12
    26.1%
    20
    40.8%
    32
    33.7%
    Other
    2
    4.3%
    6
    12.2%
    8
    8.4%
    Unknown
    2
    4.3%
    2
    4.1%
    4
    4.2%
    Region of Enrollment (participants) [Number]
    United States
    46
    100%
    49
    100%
    95
    100%
    Forced expiratory volume at one second (FEV1) % predicted (percent predicted of FEV1) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [percent predicted of FEV1]
    29.5
    (9.5)
    29
    (8.1)
    29.2
    (8.7)

    Outcome Measures

    1. Primary Outcome
    Title FEV1 Percent Predicted
    Description
    Time Frame 4 hours post-randomization

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Budesonide Placebo
    Arm/Group Description Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO
    Measure Participants 46 49
    Mean (Standard Deviation) [percent predicted of FEV1]
    51.7
    (16.8)
    52.6
    (15.8)
    2. Secondary Outcome
    Title Hospitalization
    Description
    Time Frame 6 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Budesonide Placebo
    Arm/Group Description Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO
    Measure Participants 46 49
    Number [percentage of participants]
    39
    84.8%
    39
    79.6%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Budesonide Placebo
    Arm/Group Description Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO
    All Cause Mortality
    Budesonide Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Budesonide Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/46 (0%) 0/49 (0%)
    Other (Not Including Serious) Adverse Events
    Budesonide Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/46 (0%) 0/49 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Robert Silverman
    Organization North Shore Long Island Jewish Health System
    Phone 718-470-7501
    Email rsilverman@nshs.edu
    Responsible Party:
    Robert A Silverman, Physician, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT00588406
    Other Study ID Numbers:
    • 07.02.019
    First Posted:
    Jan 8, 2008
    Last Update Posted:
    Jan 21, 2016
    Last Verified:
    Dec 1, 2015