Back to resultsTreatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids
Primary Purpose
Asthma Exacerbation
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
inhalation of corticosteroids
Sponsored by
About this trial
This is an interventional treatment trial for Asthma Exacerbation focused on measuring Dyspnea, Cough
Eligibility Criteria
Inclusion Criteria:
- Asthmatic patients aged 18-60 with PFR < 60% of predicted
Exclusion Criteria:
- Patients with other chronic diseases
- cardiac renal hepatic etc will be excluded
Sites / Locations
- ER Soroka Med Center
Outcomes
Primary Outcome Measures
PFT improvment
Admission rate
Secondary Outcome Measures
Full Information
NCT ID
NCT00397267
First Posted
November 8, 2006
Last Updated
November 26, 2006
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00397267
Brief Title
Treatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Soroka University Medical Center
4. Oversight
5. Study Description
Brief Summary
We assume that the combination of systemic steroids and inhaled steroid in the first hour of treatment in the ER will decrease the admission rate and improve faster the pulmonary function.
120 patients refferd to the ER due to asthma attack aged 18-60 with PFR < 60% 0o predicted will participate in the study after giving informed consent.
The usual treatment in the ER is inhalation of Beta 2 short acting and I.V solumedrol 120 mg . The study group will recieve in addition 3 inhalation of Budesonide 1000 microgram each during the first hour.
The controlled group will recieve Nacl 0.9% PFR will be followed 0 30 60 120 min.
Detailed Description
Primary end points- PFT improvment and admission rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Exacerbation
Keywords
Dyspnea, Cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
inhalation of corticosteroids
Primary Outcome Measure Information:
Title
PFT improvment
Title
Admission rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Asthmatic patients aged 18-60 with PFR < 60% of predicted
Exclusion Criteria:
Patients with other chronic diseases
cardiac renal hepatic etc will be excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dov Heimer M.D. Heimer, AS. Proffessor
Phone
972 8 6400807
Email
heimerd@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
LUNA Avnon, M.D
Phone
972 8 6403024
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dov Heimer, M.D
Organizational Affiliation
BGU Soroka medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
ER Soroka Med Center
City
Beer-Sheva
ZIP/Postal Code
P.O.Box 151
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Treatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids
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