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Nebulized Budesonide Combined With Systemic Corticosteroid in Acute Severe Asthma

Nebulized Budesonide Combined With Systemic Corticosteroid in Acute Severe Asthma Managed in the Emergency Department: A Randomized Controlled Trial

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04016220
Enrollment
60
Registered
2019-07-11
Start date
2019-05-20
Completion date
2020-05-20
Last updated
2019-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Asthma

Keywords

asthma, budesonide, nebulized, adult

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

Detailed description

Patients were included in a double-blind, randomized into one of two groups. The experimental group received a first nebulization of 5 mg of terbutaline (Bricanyl®, AstraZeneca : solution of 5mg/ 2 ml ) in association with 0.5 mg of ipratropium bromide (Ipratropium®, AGUETTANT, solution of 0.5 mg/ 2 ml) and 0.5 mg of budesonide (Pulmicort®, AstraZeneca, 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. The control group received a first nebulization of 5 mg of terbutaline in association with 0.5 mg of ipratropium bromide and 2 ml of normal saline followed by a repetitive nebulization of 5 mg de terbutaline with 2 ml of normal saline at 20, 40, 60 and 120 min (Figure 1). The placebo and the budesonide were prepared by the pharmacist. All patients received hydrocortisone hemisuccinate (100 mg i.v.) and O2 (7 l/ min) via a nebulizer (Mini nebulizer 40-115510; Peters, France). Measure The following parameters were measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation: peak expiratory flow (PEF), respiratory rate (RR), heart rate (HR), dyspnea scale, systolic and diastolic blood pressure. PEF was measured with peak flow meter (mini-Wright; Clement Clarke; Harlow, UK). The highest of three values was recorded. HR was measured from continuous monitor. Dyspnea was assessed by the patient's own sensation of respiratory difficulty with a value assigned on a scale of 0 to 3, in which 0 denoted absent, 1 mild, 2 moderate, and 3 severe. At the end of the treatment, the patient was asked to indicate the presence or absence of each of five symptoms: palpitations, tremor, anxiety, headache, and dry mouth. Also, an interviewer determined the duration of symptoms before presentation, which specifically included how long the patient had been wheezing and shorter of breath than usual; a decline in the PEF, if available, was considered. The occurrence of a worsening of ventilator status requiring mechanical ventilation led to interrupt the study protocol. The decision to discharge or admit a patient was made at the end of the protocol (180 minutes) by a senior ED staff without knowledge of previous patient group allocation. Although some patients met discharge criteria during the study, none were discharged until the end of the protocol. Patients were discharged from the ED according to the following criteria: if accessory-muscle use disappeared, if wheezing was judged minimal to completely resolved, if they were free of dyspnea, and if PEF was more than 60% of predicted value. Physicians prescribed oral prednisone (40 mg for 7 days) for all discharged patients.

Interventions

DRUGBudesonide

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.

DRUGnormal 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

University of Monastir
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

senior ED and patient do not know the randomization group

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
admission rate3 hoursThe decision to discharge or admit a patient was made at the end of the protocol (180 minutes)

Secondary

MeasureTime frameDescription
respiratory rate was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation.3 hoursrespiratory rate
dyspnea scale3 hoursDyspnea was assessed by the patient's own sensation of respiratory difficulty with a value assigned on a scale of 0 to 3, in which 0 denoted absent, 1 mild, 2 moderate, and 3 severe. was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation:
Hear rate3 hoursHeart rate was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation.
Peak expiratory flow3 hoursPeak expiratory flow (L/min) was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation.
dry mouth3 hoursincidence of dry mouth
palpitation3 hoursincidence of palpitation
headache3 hoursincidence of headache
tremor3 hoursincidence of tremor

Countries

Tunisia

Contacts

Primary ContactSoudani Marghli, Professor
soudani.marghli@rns.tn00 216 73 109 019
Backup ContactChafiaa Bouhamed, Assistant Professor
bouhamedchafiaa@yahoo.fr00 216 95 014 321

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026