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

Primary Purpose

Asthma in Children

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Budesonide Formoterol Drug Combination
nebulisation of terbutaline
Sponsored by
Centre Hospitalier Intercommunal Creteil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in Children

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Ambroise Paré
  • CHU Antoine Béclère
  • Centre Hospitalier Sud Francilien
  • CHI Créteil
  • Grand Hôpital de l'Est Francilien
  • CHU Bicêtre
  • CHU Lille
  • CHI Villeneuve-Saint-Georges

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

budesonide/formoterol Turbuhaler®

nebulisation of terbutaline

Arm Description

After randomization, patients in the experimental arm will receive budesonide/formoterol Turbuhaler® 100/6 μg, one inhalation every 5 minutes (Maximum 12 inhalations).

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. In case of an insufficient response, 3 additional doses will be administered for a maximum of 6 nebulisations.

Outcomes

Primary Outcome Measures

Percentage of success
Percentage of success define by a pulmonary score < 3 according to the number of administrations necessary to obtain this score.

Secondary Outcome Measures

Number of hospitalized patients
Number of hospitalized patients
Time spent in ER
Number of hours of stay in the ER
Score for the inhalation technique
Score for the inhalation technique at each procedure from 0 to 3
Score on the Asthma Control Questionnaire (ACT)
Score on the Asthma Control Questionnaire (ACT)
Score on the Asthma Control Questionnaire (ACT)
Score on the Asthma Control Questionnaire (ACT)
Number of medical visit
Number of medical visits at 1 week and 1 month following the exacerbation
controlled asthma
Number of patients with a controlled asthma at 1 month following the exacerbation
Adverse events
Number of adverse events
FEV1
FEV1 volume at 1 month
Total pulmonary capacity
Total pulmonary capacity at 1 month
Vital capacity (VC)
Vital capacity volume at 1 month
FEV1/FVC ratio
FEV1/FVC ratio at 1 month
Pulmonary score
Pulmonary score at each procedure from 0 to 9
Oxygen saturation
Oxygen saturation at each procedure expressed as a percentage
Respiratory rate
Respiratory rate number of breathing cycles per minute

Full Information

First Posted
January 4, 2021
Last Updated
July 24, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04705727
Brief Title
Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Moderate Asthma Exacerbation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Not enough recruitment in th trial
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
September 23, 2021 (Actual)
Study Completion Date
June 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
budesonide/formoterol Turbuhaler®
Arm Type
Experimental
Arm Description
After randomization, patients in the experimental arm will receive budesonide/formoterol Turbuhaler® 100/6 μg, one inhalation every 5 minutes (Maximum 12 inhalations).
Arm Title
nebulisation of terbutaline
Arm Type
Active Comparator
Arm Description
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. In case of an insufficient response, 3 additional doses will be administered for a maximum of 6 nebulisations.
Intervention Type
Drug
Intervention Name(s)
Budesonide Formoterol Drug Combination
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
nebulisation of terbutaline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of success
Description
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
Secondary Outcome Measure Information:
Title
Number of hospitalized patients
Description
Number of hospitalized patients
Time Frame
during the month following the asthma attack
Title
Time spent in ER
Description
Number of hours of stay in the ER
Time Frame
Up to discharge from the emergency room
Title
Score for the inhalation technique
Description
Score for the inhalation technique at each procedure from 0 to 3
Time Frame
Immediately after each inhalation procedure
Title
Score on the Asthma Control Questionnaire (ACT)
Description
Score on the Asthma Control Questionnaire (ACT)
Time Frame
1 week after randomisation
Title
Score on the Asthma Control Questionnaire (ACT)
Description
Score on the Asthma Control Questionnaire (ACT)
Time Frame
1 month after randomisation
Title
Number of medical visit
Description
Number of medical visits at 1 week and 1 month following the exacerbation
Time Frame
1 week and 1 month following the exacerbation
Title
controlled asthma
Description
Number of patients with a controlled asthma at 1 month following the exacerbation
Time Frame
1 month following the exacerbation
Title
Adverse events
Description
Number of adverse events
Time Frame
Up to 1 month following the exacerbation
Title
FEV1
Description
FEV1 volume at 1 month
Time Frame
1 month
Title
Total pulmonary capacity
Description
Total pulmonary capacity at 1 month
Time Frame
1 month
Title
Vital capacity (VC)
Description
Vital capacity volume at 1 month
Time Frame
1 month
Title
FEV1/FVC ratio
Description
FEV1/FVC ratio at 1 month
Time Frame
1 month
Title
Pulmonary score
Description
Pulmonary score at each procedure from 0 to 9
Time Frame
Within 5 minutes following each inhalation procedure
Title
Oxygen saturation
Description
Oxygen saturation at each procedure expressed as a percentage
Time Frame
Within 5 minutes following each inhalation procedure
Title
Respiratory rate
Description
Respiratory rate number of breathing cycles per minute
Time Frame
Within 5 minutes following each inhalation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Ambroise Paré
City
Boulogne-Billancourt
Country
France
Facility Name
CHU Antoine Béclère
City
Clamart
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
Country
France
Facility Name
CHI Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Grand Hôpital de l'Est Francilien
City
Jossigny
Country
France
Facility Name
CHU Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
CHU Lille
City
Lille
Country
France
Facility Name
CHI Villeneuve-Saint-Georges
City
Villeneuve-Saint-Georges
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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