Asthma Acute study: Nebulized ketamine
Official title Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations
ClinicalTrials.gov ID: NCT07112456
What this study is testing
What is Nebulized ketamine (0.5 mg/kg in normal saline)?
An investigational inhaled medication being studied as a potential treatment for acute asthma exacerbations.
Also referred to as Ketamine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if inhaled ketamine improves breathing more than standard treatment and to assess any side effects of the drug.
- Who it's for
- Adults who are having a moderate or severe asthma attack and are treated in an emergency department.
- What's involved
- Participants receive either a ketamine mist or a saltwater placebo mist along with their regular asthma care. Their breathing is measured before and after, and they are watched for 60 minutes for symptoms, vital signs, and side effects.
- Time commitment
- The study lasts about one hour, during which participants have a few tests and are monitored for side effects.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- Adults aged 18 years or older presenting to the Emergency Department with a clinical diagnosis of moderate to severe asthma exacerbation based on...
- PEFR between 33% and 75% of predicted value or personal best, as measured using a peak flow meter.
- Stable vital signs as deemed by the treating physician
- Alert and oriented, able to understand the study purpose and provide informed consent.
- Not requiring immediate advanced airway intervention, including intubation or emergency non-invasive ventilation.
You likely can't join if
- Known hypersensitivity or allergy to ketamine or any component of the nebulized solution.
- History of psychosis, schizophrenia, or other severe uncontrolled psychiatric disorders.
- Uncontrolled hypertension, defined as systolic BP \> 180 mmHg or diastolic BP \> 110 mmHg on two consecutive readings at least 5 minutes apart...
- Hemodynamic instability, including persistent hypotension (SBP \< 90 mmHg) or tachyarrhythmias requiring urgent treatment.
- COPD with frequent exacerbations or baseline FEV₁ \< 50% predicted
- Interstitial lung disease (ILD)
See the full eligibility criteria
- Adults aged 18 years or older presenting to the Emergency Department with a clinical diagnosis of moderate to severe asthma exacerbation based on SIGN (Scottish Intercollegiate Guidelines Network) criteria.
- PEFR between 33% and 75% of predicted value or personal best, as measured using a peak flow meter.
- Stable vital signs as deemed by the treating physician
- Alert and oriented, able to understand the study purpose and provide informed consent.
- Not requiring immediate advanced airway intervention, including intubation or emergency non-invasive ventilation.
- Known hypersensitivity or allergy to ketamine or any component of the nebulized solution.
- History of psychosis, schizophrenia, or other severe uncontrolled psychiatric disorders.
- Uncontrolled hypertension, defined as systolic BP \> 180 mmHg or diastolic BP \> 110 mmHg on two consecutive readings at least 5 minutes apart, despite initial ED management.
- Hemodynamic instability, including persistent hypotension (SBP \< 90 mmHg) or tachyarrhythmias requiring urgent treatment.
- COPD with frequent exacerbations or baseline FEV₁ \< 50% predicted
- Interstitial lung disease (ILD)
- Clinically significant bronchiectasis with baseline productive cough or infection
- Pregnancy or currently breastfeeding.
- Home BiPAP use or requirement for non-invasive ventilation (e.g., BiPAP/CPAP) during the ED visit (Note: isolated home CPAP for sleep apnea without daytime symptoms is acceptable).
- Current intubation or imminent need for mechanical ventilation based on clinical judgment.
- Severe cardiac disease, including decompensated heart failure, recent myocardial infarction (\<6 weeks), or known severe valvular disease.
- Any other medical, surgical, or psychiatric condition that in the opinion of the investigator would place the patient at undue risk from study participation or interfere with the interpretation of study results.
The study team makes the final eligibility decision.
Where it is enrolling
- Muscat, Alkhoudh, Oman
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but 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?
This study is enrolling now at Muscat, Alkhoudh, Oman. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.