AzTrials
AzTrials

Asthma in ChildrenPhase 3ASTHMAFASTNCT04705727

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

A Phase 3 study testing Budesonide Formoterol Drug Combination and nebulisation of terbutaline in people with Asthma in Children, run by Centre Hospitalier Intercommunal Creteil at 8 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 8 to 17 years
Conditions the study is for
Asthma in Children
What is being tested?
Budesonide Formoterol Drug Combination and nebulisation of terbutaline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
8 sitesFrance
Study dates
23 Aug 2021to 23 Jun 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • CHU Ambroise Paré

    Boulogne-Billancourt

  • CHU Antoine Béclère

    Clamart

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes

  • CHI Créteil

    Créteil, 94000

  • Grand Hôpital de l'Est Francilien

    Jossigny

  • CHU Bicêtre

    Le Kremlin-Bicêtre, 94270

  • CHU Lille

    Lille

  • CHI Villeneuve-Saint-Georges

    Villeneuve-Saint-Georges

Other trials in France

About this study

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

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)

Being tested
Budesonide Formoterol Drug Combination, nebulisation of terbutaline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Budesonide Formoterol Drug CombinationDrug

    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 terbutalineDrug

    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.

Study groups in NCT04705727
Study groupRoleWhat they receive
budesonide/formoterol Turbuhaler®ExperimentalAfter randomization, patients in the experimental arm will receive budesonide/formoterol Turbuhaler® 100/6 μg, one inhalation every 5 minutes (Maximum 12 inhalations).
Receives: Drug: Budesonide Formoterol Drug Combination
nebulisation of terbutalineActive comparator0.1 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.
Receives: Drug: nebulisation of terbutaline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of success

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

    Measured: Up 30 minutes after the last administration

Secondary outcomes (15)

  1. Number of hospitalized patients

    Number of hospitalized patients

    Measured: during the month following the asthma attack

  2. Time spent in ER

    Number of hours of stay in the ER

    Measured: Up to discharge from the emergency room

  3. Score for the inhalation technique

    Score for the inhalation technique at each procedure from 0 to 3

    Measured: Immediately after each inhalation procedure

  4. Score on the Asthma Control Questionnaire (ACT)

    Score on the Asthma Control Questionnaire (ACT)

    Measured: 1 week after randomisation

  5. Score on the Asthma Control Questionnaire (ACT)

    Score on the Asthma Control Questionnaire (ACT)

    Measured: 1 month after randomisation

  6. Number of medical visit

    Number of medical visits at 1 week and 1 month following the exacerbation

    Measured: 1 week and 1 month following the exacerbation

  7. controlled asthma

    Number of patients with a controlled asthma at 1 month following the exacerbation

    Measured: 1 month following the exacerbation

  8. Adverse events

    Number of adverse events

    Measured: Up to 1 month following the exacerbation

  9. FEV1

    FEV1 volume at 1 month

    Measured: 1 month

  10. Total pulmonary capacity

    Total pulmonary capacity at 1 month

    Measured: 1 month

  11. Vital capacity (VC)

    Vital capacity volume at 1 month

    Measured: 1 month

  12. FEV1/FVC ratio

    FEV1/FVC ratio at 1 month

    Measured: 1 month

  13. Pulmonary score

    Pulmonary score at each procedure from 0 to 9

    Measured: Within 5 minutes following each inhalation procedure

  14. Oxygen saturation

    Oxygen saturation at each procedure expressed as a percentage

    Measured: Within 5 minutes following each inhalation procedure

  15. Respiratory rate

    Respiratory rate number of breathing cycles per minute

    Measured: Within 5 minutes following each inhalation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2021
  2. Study start23 Aug 2021
  3. Primary completion23 Sep 2021
  4. Study completion23 Jun 2023

Why it stopped: Not enough recruitment in th trial

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04705727
Sponsor's protocol ID
ASTHMAFAST
Acronym
ASTHMAFAST
Status last verified
Jul 2023
First submitted
4 Jan 2021
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide Formoterol Drug Combination and nebulisation of terbutaline in people with Asthma in Children, run by Centre Hospitalier Intercommunal Creteil at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Not enough recruitment in th trial). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of success (time frame: Up 30 minutes after the last administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04705727.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in