Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Moderate Asthma Exacerbation

Asthma in Children Clinical Trial

— ASTHMAFAST  

Official title:

Comparison of the Efficacy and Safety of Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Asthma Presenting at the Emergency Room for Moderate Exacerbation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04705727
• Other study ID #: ASTHMAFAST
• Status: Terminated
• Phase: Phase 3
• Start date: August 23, 2021
• Est. completion date: June 23, 2023

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Combined use of inhaled corticosteroids and long-acting β-agonists (LABAs) as the controller and the quick relief therapy termed single maintenance and reliever therapy (SMART) is a potential therapeutic regimen for the management of persistent asthma. A recent systematic review supports the combined use of inhaled corticosteroids and LABA as both the controller and quick relief therapy (SMART) among patients aged 12 years. In Emergency room (ER), Meta-analysis showed that using salbutamol (or albuterol) by meter doses inhaler (MDI) with a valved holding chamber (VHC) in children with moderate-severe acute asthma exacerbation was more effective, that is, fewer hospital admissions, more clinical improvement, and had fewer adverse effects (tremor and tachycardia) than salbutamol by nebulizer. Therefore, several international guidelines recommend the use of salbutamol by MDI rather than by nebulizer for moderate-severe asthma exacerbations. In children older than 8 years old, dry-powder inhaler (DPI), a device that delivers medication to the lungs in the form of a dry powder is currently used for maintenance and reliever therapy rather than MDI. In this context, we aim to assess the use of combined inhaled corticosteroids and long-acting β-agonists (LABAs) as a quick relief therapy in children older than 8 years old presenting at the ER with moderate asthma exacerbation. Acute asthma patients who had severe exacerbation were excluded from this study (these patients receiving systematically continuous nebulized salbutamol and/or intravenous salbutamol upon their arrival)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: June 23, 2023
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• Children 8-17 years

• Children consulting to the ER with moderate asthma exacerbation (defined by the Pulmonary Score > 3 and =7)

• Score for the inhalation technique = 3

• French social security affiliation

Exclusion Criteria:

• Pneumonia

• Pulmonary and/or cardiac congenital malformations

• Chronic pulmonary disease other than asthma (bronchopulmonary dysplasia, cystic fibrosis, or post infectious bronchiolitis obliterans)

• Foreign body aspiration

• Neurological alteration

• Severe asthma exacerbation defined by Pulmonary Score > 7

• Cardiopulmonary failure imminent or mechanical ventilation indication

• Thyrotoxicosis, pheochromocytoma, type 2 diabetes, untreated hypokalemia, obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other serious cardiovascular disorders such as ischemic heart disease, tachyarrhythmias or severe heart failure.

• Pregnancy

• Breastfeeding woman

• Ongoing participation in RIPH1 Intervention Research

• History of intolerance to terbutaline

• Hypersensitivity to the active ingredient or any excipients of terbutaline

• Hypersensitivity (allergy) to budesonide, formoterol or any component of the product (lactose may contain milk proteins in small quantities)

• Patient with an ongoing treatment of itraconazole, ritonavir or other potent CYP3A4 inhibitor, quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors (MAOIs), beta-blockers (including eyedrops) and tricyclic antidepressants

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Drug:
• Budesonide Formoterol Drug Combination
This combination will be used to treat the asthma exacerbation, patients will take one inhalation of budesonide/formoterol Turbuhaler® 100/6 µg every 5 minutes (Maximum 12 inhalations).
• nebulisation of terbutaline
Patients will receive 0.1 mg/kg nebulized terbutaline 5 mg/2 ml of Terbutaline dilution diluted with 2 ml normal saline delivered by an air compressor nebuliser driven by oxygen at a flow rate of 8l/min. The duration of one dose will be approximately 20 minutes and a total of 3 doses will be administered.

Locations

Country	Name	City	State
France	CHU Ambroise Paré	Boulogne-Billancourt
France	CHU Antoine Béclère	Clamart
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes
France	CHI Créteil	Créteil
France	Grand Hôpital de l'Est Francilien	Jossigny
France	CHU Bicêtre	Le Kremlin-Bicêtre
France	CHU Lille	Lille
France	CHI Villeneuve-Saint-Georges	Villeneuve-Saint-Georges

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of success	Percentage of success define by a pulmonary score < 3 according to the number of administrations necessary to obtain this score.	Up 30 minutes after the last administration
Secondary	Number of hospitalized patients	Number of hospitalized patients	during the month following the asthma attack
Secondary	Time spent in ER	Number of hours of stay in the ER	Up to discharge from the emergency room
Secondary	Score for the inhalation technique	Score for the inhalation technique at each procedure from 0 to 3	Immediately after each inhalation procedure
Secondary	Score on the Asthma Control Questionnaire (ACT)	Score on the Asthma Control Questionnaire (ACT)	1 week after randomisation
Secondary	Score on the Asthma Control Questionnaire (ACT)	Score on the Asthma Control Questionnaire (ACT)	1 month after randomisation
Secondary	Number of medical visit	Number of medical visits at 1 week and 1 month following the exacerbation	1 week and 1 month following the exacerbation
Secondary	controlled asthma	Number of patients with a controlled asthma at 1 month following the exacerbation	1 month following the exacerbation
Secondary	Adverse events	Number of adverse events	Up to 1 month following the exacerbation
Secondary	FEV1	FEV1 volume at 1 month	1 month
Secondary	Total pulmonary capacity	Total pulmonary capacity at 1 month	1 month
Secondary	Vital capacity (VC)	Vital capacity volume at 1 month	1 month
Secondary	FEV1/FVC ratio	FEV1/FVC ratio at 1 month	1 month
Secondary	Pulmonary score	Pulmonary score at each procedure from 0 to 9	Within 5 minutes following each inhalation procedure
Secondary	Oxygen saturation	Oxygen saturation at each procedure expressed as a percentage	Within 5 minutes following each inhalation procedure
Secondary	Respiratory rate	Respiratory rate number of breathing cycles per minute	Within 5 minutes following each inhalation procedure