- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00397267
Treatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Dov Heimer M.D. Heimer, AS. Proffessor
- Phone Number: 972 8 6400807
- Email: heimerd@clalit.org.il
Study Contact Backup
- Name: LUNA Avnon, M.D
- Phone Number: 972 8 6403024
Study Locations
-
-
-
Beer-Sheva, Israel, P.O.Box 151
- ER Soroka Med Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
PFT improvment
|
Admission rate
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dov Heimer, M.D, BGU Soroka medical center
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOR440906CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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