Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00397267
Other study ID # SOR440906CTIL
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received November 8, 2006
Last updated November 26, 2006
Start date January 2007
Est. completion date December 2007

Study information

Verified date October 2006
Source Soroka University Medical Center
Contact Dov Heimer M.D. Heimer, AS. Proffessor
Phone 972 8 6400807
Email heimerd@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

Primary end points- PFT improvment and admission rate.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
inhalation of corticosteroids


Locations

Country Name City State
Israel ER Soroka Med Center Beer-Sheva

Sponsors (1)

Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary PFT improvment
Primary Admission rate
See also
  Status Clinical Trial Phase
Completed NCT01260623 - Pilot Study of How Children With Asthma Exacerbations Metabolize Prednisone N/A
Recruiting NCT01179152 - Study of Preventive Treatment With Symbicort or Budicort Turbohaler in Childhood Asthma Return to School Epidemic N/A
Completed NCT00952471 - Reduction in Clinical Variance Using Targeted Design Changes in Computerized Provider Order Entry Order (CPOE) Sets Phase 3
Not yet recruiting NCT05484037 - Application of Telehealth Technology in Asthma Management N/A
Active, not recruiting NCT04480242 - Asthma Research in Children and Adolescents
Completed NCT03392363 - Diagnosing Respiratory Disease in Children Using Cough Sounds 2
Withdrawn NCT00846014 - Asthma Exacerbation and Helium-3 MRI N/A
Completed NCT06156462 - A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Adolescent and Adult Patients in an Emergency Department
Completed NCT03029156 - Effectiveness of the Aeroneb in Acute Severe Asthma N/A
Not yet recruiting NCT06291740 - Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department N/A