Nebulized Budesonide Combined With Systemic Corticosteroid in Acute Severe Asthma

NCT04016220 | Unknown Phase 1

• 1 other identifier: University of Monastir
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

asthma; budesonide; nebulized; adult

Outcome Measures

Primary Outcomes (1)

• admission rate

  The decision to discharge or admit a patient was made at the end of the protocol (180 minutes)

  3 hours

Secondary Outcomes (8)

• Peak expiratory flow

  3 hours

• respiratory rate was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation.

  3 hours

• dyspnea scale

  3 hours

• Hear rate

  3 hours

• tremor

  3 hours

Study Arms (2)

Budesonide group

EXPERIMENTAL

The experimental group received a first nebulization of 5 mg of terbutaline(solution of 5mg/ 2 ml ) in association with 0.5 mg of ipratropium bromide (solution of 0.5 mg/ 2 ml) and 0.5 mg of budesonide (solution of 0.5 mg/2 ml) followed by repetitive nebulization of 5 mg of terbutaline with 0.5 mg of budesonide at 20, 40, 60 and 120 min. All patients received hydrocortisone hemisuccinate (100 mg i.v.) and O2 (7 l/ min) via a nebulizer.

Drug: Budesonide

normal saline

PLACEBO COMPARATOR

The control group received a nebulization of 2 ml normal saline at baseline, 20, 40, 60 and 120 min as placebo comparator in association with nebulized terbutaline . All patients received hydrocortisone hemisuccinate (100 mg i.v.) and O2 (7 l/ min) via a nebulizer.

Drug: normal saline

Interventions

Budesonide DRUG

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.

Budesonide group

normal saline DRUG

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.

normal saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• acute asthma
• peak expiratory flow (PEF) rate less than 50% of predicted value
• one or more of the following features were present: accessory muscle activity, a heart rate greater than 110 beats/minute, a respiratory rate greater than 25 breaths/minute, a limited ability to speak
• written informed consent obtained

You may not qualify if:

• temperature higher than 38°C
• history of cardiac, hepatic, renal, or other medical disease
• pregnant

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

University of Monastir

Monastir, 5000, Tunisia

RECRUITING

Related Publications (4)

• Guttman A, Afilalo M, Colacone A, Kreisman H, Dankoff J. The effects of combined intravenous and inhaled steroids (beclomethasone dipropionate) for the emergency treatment of acute asthma. The Asthma ED Study Group. Acad Emerg Med. 1997 Feb;4(2):100-6. doi: 10.1111/j.1553-2712.1997.tb03714.x.

  PMID: 9043535 BACKGROUND

• Bateman ED, Fairall L, Lombardi DM, English R. Budesonide/formoterol and formoterol provide similar rapid relief in patients with acute asthma showing refractoriness to salbutamol. Respir Res. 2006 Jan 24;7(1):13. doi: 10.1186/1465-9921-7-13.

  PMID: 16433920 BACKGROUND

• Rodrigo GJ. Comparison of inhaled fluticasone with intravenous hydrocortisone in the treatment of adult acute asthma. Am J Respir Crit Care Med. 2005 Jun 1;171(11):1231-6. doi: 10.1164/rccm.200410-1415OC. Epub 2005 Mar 11.

  PMID: 15764724 RESULT

• Marghli S, Bouhamed C, Sghaier A, Chebbi N, Dlala I, Bettout S, Belkacem A, Kbaier S, Jerbi N, Bellou A. Nebulized budesonide combined with systemic corticosteroid vs systemic corticosteroid alone in acute severe asthma managed in the emergency department: a randomized controlled trial. BMC Emerg Med. 2022 Jul 23;22(1):134. doi: 10.1186/s12873-022-00691-9.

  PMID: 35870902 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Budesonide; Saline Solution

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Soudani Marghli, Professor

  University of Monastir Tunisia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soudani Marghli, Professor

CONTACT

00 216 73 109 019; soudani.marghli@rns.tn

Chafiaa Bouhamed, Assistant Professor

CONTACT

00 216 95 014 321; bouhamedchafiaa@yahoo.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: senior ED and patient do not know the randomization group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: July 11, 2019
• Study Start: May 20, 2019
• Primary Completion: December 20, 2019
• Study Completion: May 20, 2020
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)