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Nebulized Budesonide Combined With Systemic Corticosteroid in Acute Severe Asthma

NCT04016220 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-07-11

No results posted yet for this study

Summary

Our study is a prospective double-blind randomized study performed in the Emergency Department (ED). The objective of our study was to demonstrate the additive effect of high and repeated doses of inhaled budesonide combined with the standard treatment of acute asthma in adult managed in the ED

Conditions

  • Acute Asthma

Interventions

DRUG

Budesonide

first nebulization of 0.5 mg of budesonide in association with terbutaline and ippratropium bromide followed by repetitive nebulization of 5 mg of terbutaline with 0.5 mg of budesonide at 20, 40, 60 and 120 min.

DRUG

normal saline

first nebulization of 2ml of normal saline as placebo comparator in association with terbutaline and ippratropium bromide followed by repetitive nebulization of 5 mg of terbutaline with 2 ml of normal saline at 20, 40, 60 and 120 min.

Sponsors & Collaborators

  • University of Monastir

    lead OTHER

Principal Investigators

  • Soudani Marghli, Professor · University of Monastir Tunisia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2019-12-20
Completion
2020-05-20

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04016220 on ClinicalTrials.gov