Treatment of Acute Asthma in ER With Combination of Syste... | NCT00397267

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

NCT00397267

Sponsor

Soroka University Medical Center

Status

Unknown status

Last Update Posted

Nov 28, 2006Estimated

Enrollment

120

Phase

Phase 4

Conditions

Asthma Exacerbation

Interventions

inhalation of corticosteroids

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Dec 2007

First Submitted Date

Nov 8, 2006

First Submission Date that Met QC Criteria

Nov 8, 2006

First Posted Date

Nov 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2006

Last Update Posted Date

Nov 28, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
inhalation of corticosteroids	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dov Heimer M.D. Heimer, AS. Proffessor	Contact	972 8 6400807		heimerd@clalit.org.il
LUNA Avnon, M.D	Contact	972 8 6403024

Overall Officials

Name	Affiliation	Role
Dov Heimer, M.D	BGU Soroka medical center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ER Soroka Med Center		Beersheba		P.O.Box 151	Israel

Condition Browse Module

MeSH Terms

ID	Term
D004417	Dyspnea
D003371	Cough

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
PFT improvment
Admission rate