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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
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).
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.
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, France
Percentage of success
Percentage of success define by a pulmonary score \< 3 according to the number of administrations necessary to obtain this score.
Time frame: Up 30 minutes after the last administration
Number of hospitalized patients
Number of hospitalized patients
Time frame: during the month following the asthma attack
Time spent in ER
Number of hours of stay in the ER
Time frame: Up to discharge from the emergency room
Score for the inhalation technique
Score for the inhalation technique at each procedure from 0 to 3
Time frame: Immediately after each inhalation procedure
Score on the Asthma Control Questionnaire (ACT)
Score on the Asthma Control Questionnaire (ACT)
Time frame: 1 week after randomisation
Score on the Asthma Control Questionnaire (ACT)
Score on the Asthma Control Questionnaire (ACT)
Time frame: 1 month after randomisation
Number of medical visit
Number of medical visits at 1 week and 1 month following the exacerbation
Time frame: 1 week and 1 month following the exacerbation
controlled asthma
Number of patients with a controlled asthma at 1 month following the exacerbation
Time frame: 1 month following the exacerbation
Adverse events
Number of adverse events
Time frame: Up to 1 month following the exacerbation
FEV1
FEV1 volume at 1 month
Time frame: 1 month
Total pulmonary capacity
Total pulmonary capacity at 1 month
Time frame: 1 month
Vital capacity (VC)
Vital capacity volume at 1 month
Time frame: 1 month
FEV1/FVC ratio
FEV1/FVC ratio at 1 month
Time frame: 1 month
Pulmonary score
Pulmonary score at each procedure from 0 to 9
Time frame: Within 5 minutes following each inhalation procedure
Oxygen saturation
Oxygen saturation at each procedure expressed as a percentage
Time frame: Within 5 minutes following each inhalation procedure
Respiratory rate
Respiratory rate number of breathing cycles per minute
Time frame: Within 5 minutes following each inhalation procedure
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