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

NCT ID: NCT00397267

Last Updated: 2006-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-12-31

Brief Summary

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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

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Primary end points- PFT improvment and admission rate.

Conditions

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Asthma Exacerbation

Keywords

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Dyspnea Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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inhalation of corticosteroids

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Dov Heimer, M.D

Role: PRINCIPAL_INVESTIGATOR

BGU Soroka medical center

Locations

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ER Soroka Med Center

Beersheba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Dov Heimer M.D. Heimer, AS. Proffessor

Role: CONTACT

Phone: 972 8 6400807

Email: [email protected]

LUNA Avnon, M.D

Role: CONTACT

Phone: 972 8 6403024

Other Identifiers

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SOR440906CTIL

Identifier Type: -

Identifier Source: org_study_id