NCT00397267

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 28, 2006

Status Verified

October 1, 2006

First QC Date

November 8, 2006

Last Update Submit

November 26, 2006

Conditions

Asthma Exacerbation

Keywords

DyspneaCough

Outcome Measures

Primary Outcomes (2)

  • PFT improvment

  • Admission rate

Interventions

inhalation of corticosteroidsDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Asthmatic patients aged 18-60 with PFR \< 60% of predicted

You may not qualify if:

  • Patients with other chronic diseases
  • cardiac renal hepatic etc will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ER Soroka Med Center

Beersheba, P.O.Box 151, Israel

Location

MeSH Terms

Conditions

DyspneaCough

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dov Heimer, M.D

    BGU Soroka medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dov Heimer M.D. Heimer, AS. Proffessor

CONTACT

972 8 6400807heimerd@clalit.org.il

LUNA Avnon, M.D

CONTACT

972 8 6403024

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 9, 2006

Study Start

January 1, 2007

Study Completion

December 1, 2007

Last Updated

November 28, 2006

Record last verified: 2006-10

Locations

IL(1)