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Trial record 92 of 150 for:    Ipratropium OR atrovent

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

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ClinicalTrials.gov Identifier: NCT00588406
Recruitment Status : Completed
First Posted : January 8, 2008
Results First Posted : January 21, 2016
Last Update Posted : January 21, 2016
Sponsor:
Collaborators:
AstraZeneca
Jacobi Medical Center
Nassau University Medical Center
Information provided by (Responsible Party):
Robert A Silverman, Northwell Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Budesonide
Drug: albuterol
Drug: Ipratropium bromide
Drug: Prednisone
Enrollment 95
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Budesonide Placob
Hide 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
Arm/Group Title Budesonide Placebo Total
Hide 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 Number of Baseline Participants 46 49 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 49 participants 95 participants
37.2  (11.4) 42.6  (11.4) 40  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 49 participants 95 participants
Female
29
  63.0%
22
  44.9%
51
  53.7%
Male
17
  37.0%
27
  55.1%
44
  46.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 49 participants 95 participants
White 2 3 5
Black 28 18 46
Hispanic 12 20 32
Other 2 6 8
Unknown 2 2 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 49 participants 95 participants
46 49 95
Forced expiratory volume at one second (FEV1) % predicted  
Mean (Standard Deviation)
Unit of measure:  Percent predicted of FEV1
Number Analyzed 46 participants 49 participants 95 participants
29.5  (9.5) 29  (8.1) 29.2  (8.7)
1.Primary Outcome
Title FEV1 Percent Predicted
Hide Description [Not Specified]
Time Frame 4 hours post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide Placebo
Hide 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

Overall Number of Participants Analyzed 46 49
Mean (Standard Deviation)
Unit of Measure: percent predicted of FEV1
51.7  (16.8) 52.6  (15.8)
2.Secondary Outcome
Title Hospitalization
Hide Description [Not Specified]
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide Placebo
Hide 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

Overall Number of Participants Analyzed 46 49
Measure Type: Number
Unit of Measure: percentage of participants
39 39
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Budesonide Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Budesonide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/49 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Budesonide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/49 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Silverman
Organization: North Shore Long Island Jewish Health System
Phone: 718-470-7501
EMail: rsilverman@nshs.edu
Layout table for additonal information
Responsible Party: Robert A Silverman, Northwell Health
ClinicalTrials.gov Identifier: NCT00588406     History of Changes
Other Study ID Numbers: 07.02.019
First Submitted: December 21, 2007
First Posted: January 8, 2008
Results First Submitted: October 12, 2015
Results First Posted: January 21, 2016
Last Update Posted: January 21, 2016