Treatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids

This study is not yet open for participant recruitment.

Verified by Soroka University Medical Center, October 2006

Sponsored by:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00397267

Purpose

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.

Condition	Intervention	Phase
Asthma Exacerbation	Drug: inhalation of corticosteroids	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:

PFT improvment
Admission rate

Estimated Enrollment:	120
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2007

Detailed Description:

Primary end points- PFT improvment and admission rate.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397267

Contacts

Contact: Dov Heimer M.D. Heimer, AS. Proffessor	972 8 6400807	heimerd@clalit.org.il
Contact: LUNA Avnon, M.D	972 8 6403024

Locations

Israel
ER Soroka Med Center
Beer-Sheva, Israel, P.O.Box 151

Sponsors and Collaborators

Soroka University Medical Center

Investigators

Principal Investigator:

Dov Heimer, M.D

BGU Soroka medical center

More Information

Study ID Numbers:	SOR440906CTIL
Study First Received:	November 8, 2006
Last Updated:	November 26, 2006
ClinicalTrials.gov Identifier:	NCT00397267
Health Authority:	Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:

Dyspnea
Cough

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate

Cough
Asthma
Dyspnea
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009