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New treatment option for Moderate Asthma Exacerbation
Official title Early High-flow Oxygen Therapy With nebuLized Beta-2-agonist Using a Vibrating Mesh for the Management of Moderate to Severe Asthma Exacerbation in the Emergency Department
ClinicalTrials.gov ID: NCT05691218
What this study is testing
- What it's testing
- Acute exacerbation of asthma represents an acute or sub-acute worsening in symptoms and lung function in patients with asthma. It is characterized by a progressive increase in symptoms of shortness of breath, cough, wheezing, or chest tightness.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age equal or over 18 years
- admitted in an Emergency Department with a clinical suspicion of acute exacerbation of asthma according to the Global Initiative for Asthma (GINA)...
- with at least one of the following criteria 60mn after a first treatment by beta-2 agonist adrenergic nebulization with 3 x 5 mg of terbutaline:
- Respiratory rate over 22 breaths/min
- Peak flow \< 50% of predictive normal value
You likely can't join if
- Acute exacerbation of asthma during the last 30 days
- Clinical suspicion of acute exacerbation of asthma due to anaphylaxis, pneumothorax, pneumomediastinum, pneumonia or atelectasis.
- At least ONE of the following serious signs: drowsiness, confusion, auscultatory silence
- Clinical suspicion of another pathology that could explain the respiratory failure such as heart failure, laryngeal obstruction, pulmonary embolism...
- Patients with neurological (Glasgow \< 13) or hemodynamical failure (Mean Arterial Pressure \< 65 mmHg)
- contraindication to treatment with a beta-2-adrenergic agonist
See the full eligibility criteria
- Age equal or over 18 years
- admitted in an Emergency Department with a clinical suspicion of acute exacerbation of asthma according to the Global Initiative for Asthma (GINA) criteria.
- with at least one of the following criteria 60mn after a first treatment by beta-2 agonist adrenergic nebulization with 3 x 5 mg of terbutaline:
- Respiratory rate over 22 breaths/min
- Peak flow \< 50% of predictive normal value
- SpO2 \< 95% in room air
- Signs of severe asthma exacerbation (at least one criteria): Talks in word, Agitation, Sits hunched forwards, Accessory muscles in use
- Free subject, without guardianship or curatorship or subordination
- Patients benefiting from a Social Security scheme or benefiting from it through a third party
- Informed consent signed by the patient after clear and honest information about the study
- Acute exacerbation of asthma during the last 30 days
- Clinical suspicion of acute exacerbation of asthma due to anaphylaxis, pneumothorax, pneumomediastinum, pneumonia or atelectasis.
- At least ONE of the following serious signs: drowsiness, confusion, auscultatory silence
- Clinical suspicion of another pathology that could explain the respiratory failure such as heart failure, laryngeal obstruction, pulmonary embolism, etc
- Patients with neurological (Glasgow \< 13) or hemodynamical failure (Mean Arterial Pressure \< 65 mmHg)
- contraindication to treatment with a beta-2-adrenergic agonist
- History of hypersensitivity (allergy) to terbutaline or any of the constituents
- Contraindication to OHD
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, people assessed GIR1 or GIR 2 (AGGIR grid), adults under legal protection
- Pregnant or breastfeeding women, Women at age to procreate and not using effective contraception
The study team makes the final eligibility decision.
Where it's taking place
- Poitiers, France, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poitiers, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.