Nebulized Budesonide Combined With Systemic Corticosteroid in Acute Severe Asthma

Acute Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04016220
• Other study ID #: University of Monastir
• Status: Recruiting
• Phase: Phase 1
• Start date: May 20, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: July 2019
• Source: University of Monastir
• Contact: Soudani Marghli, Professor
• Phone: 00 216 73 109 019
• Email: soudani.marghli[@]rns.tn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 20, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Asthma
• Asthma
• Status Asthmaticus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Tunisia	University of Monastir	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

References & Publications (3)

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;7:13. — View Citation

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. — View Citation

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. Epub 2005 Mar 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	admission rate	The decision to discharge or admit a patient was made at the end of the protocol (180 minutes)	3 hours
Secondary	Peak expiratory flow	Peak expiratory flow (L/min) was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation.	3 hours
Secondary	respiratory rate was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation.	respiratory rate	3 hours
Secondary	dyspnea scale	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. was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation:	3 hours
Secondary	Hear rate	Heart rate was measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation.	3 hours
Secondary	tremor	incidence of tremor	3 hours
Secondary	dry mouth	incidence of dry mouth	3 hours
Secondary	palpitation	incidence of palpitation	3 hours
Secondary	headache	incidence of headache	3 hours