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

• Sponsor: Soroka University Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00397267
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 10.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Exacerbation	Drug: inhalation of corticosteroids	Phase 4

Detailed Description

Primary end points- PFT improvment and admission rate.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2007
• Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. PFT improvment []

2. Admission rate []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00397267
• Other Study ID Numbers: SOR440906CTIL
• First Posted: Nov 9, 2006
• Last Update Posted: Nov 28, 2006
• Last Verified: Oct 1, 2006

• Keywords provided by , ,: Dyspnea; Cough
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Nov 28, 2006