ClinicalTrials.gg
RecruitingNCT07112456KET-AIRUpdated Oct 19, 2026

Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations

A Phase 2 interventional study of Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare and Placebo nebulization (5 mL normal saline) plus standard asthma care in Asthma Acute, Asthma Attack and Asthma Exacerbations, sponsored by Oman Medical Speciality Board. Recruiting at 1 site in Oman. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Oman Medical Speciality Board · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Oct 19, 2026Now RecruitingStudy documents posted+3 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to learn if nebulized ketamine helps treat moderate to severe asthma attacks in adults in the emergency department. It will also learn about the safety of ketamine when inhaled through a nebulizer.

The main questions it aims to answer are:

  • Does nebulized ketamine improve breathing more than standard treatment alone?
  • What side effects, if any, do participants experience after receiving nebulized ketamine?

Researchers will compare nebulized ketamine to a placebo (a saltwater mist with no medication) to see how well it works and how safe it is.

Participants will:

  • Receive either nebulized ketamine or a placebo mist, along with standard asthma treatment
  • Have their breathing checked before and after treatment using a peak flow meter
  • Be monitored for 60 minutes and have their symptoms, vital signs, and any side effects recorded
02

Conditions studied

  • Asthma Acute
  • Asthma Attack
  • Asthma Exacerbations

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Keywords

  • Asthma
  • Asthma, Severe
  • Asthma Exacerbation
  • Emergency Treatment
  • Ketamine
  • Ketamine, Nebulized
  • Bronchodilator Agents
  • Randomized Controlled Trial
  • Peak Expiratory Flow Rate
  • Safety and Efficacy
03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's planned enrollment of 100 is above the median of 78 across 3,341 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Oman Medical Speciality Board is the lead sponsor of 15 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. PEFR between 33% and 75% of predicted value or personal best, as measured using a peak flow meter.
  3. Stable vital signs as deemed by the treating physician
  4. Alert and oriented, able to understand the study purpose and provide .
  5. Not requiring immediate advanced airway intervention, including intubation or emergency non-invasive ventilation.

Exclusion criteria

Exclusion Criteria:

  1. Known or allergy to ketamine or any component of the nebulized solution.
  2. History of psychosis, schizophrenia, or other severe uncontrolled psychiatric disorders.
  3. 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.
  4. Hemodynamic instability, including persistent hypotension (SBP \< 90 mmHg) or tachyarrhythmias requiring urgent treatment.
  5. Significant chronic lung disease, including:

    • with frequent exacerbations or baseline \< 50% predicted
    • Interstitial lung disease (ILD)
    • bronchiectasis with baseline productive cough or infection
  6. Pregnancy or currently breastfeeding.
  7. 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).
  8. Current intubation or imminent need for mechanical ventilation based on clinical judgment.
  9. Severe cardiac disease, including decompensated heart failure, recent myocardial infarction (\<6 weeks), or known severe valvular disease.
  10. 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Nebulized ketamine (0.5 mg/kg) + standard care for moderate to severe asthma exacerbation

    Participants in the intervention arm will receive a single dose of nebulized ketamine at 0.5 mg/kg, diluted in normal saline to a total volume of 5ml, administered via a standard jet nebulizer. This will be given after standard asthma care, which includes salbutamol, ipratropium bromide, systemic corticosteroids (e.g., oral prednisolone or IV hydrocortisone), and supplemental oxygen as needed. The goal is to assess whether adding nebulized ketamine improves respiratory function, measured by peak expiratory flow rate (PEFR), compared to standard care alone. Participants will be monitored for 60 minutes after treatment for changes in PEFR, symptom relief, and any adverse effects. The intervention is non-invasive and administered in the emergency department for adult patients with moderate to severe asthma exacerbations.

    Drug: Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare

  • Placebo comparator
    Placebo nebulization (normal saline) + standard care for moderate to severe asthma exacerbation

    Participants in the control arm will receive a placebo nebulization consisting of 5 mL of normal saline, administered via a standard jet nebulizer. This will be given in addition to standard asthma care, which includes salbutamol, ipratropium bromide, systemic corticosteroids (e.g., oral prednisolone or IV hydrocortisone), and supplemental oxygen as needed. The placebo is indistinguishable in appearance and administration method from the active treatment to maintain blinding. This arm is designed to evaluate the effects of standard care alone on peak expiratory flow rate (PEFR), symptom relief, and adverse events, and will be compared to the intervention group receiving nebulized ketamine. All participants will be monitored for 60 minutes following treatment in the emergency department setting.

    Drug: Placebo nebulization (5 mL normal saline) plus standard asthma care

Interventions

  • DrugNebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare

    \*\*Intervention Description:\*\* Nebulized ketamine is administered as a single dose of 0.5 mg/kg of ketamine hydrochloride diluted in 0.9% normal saline to a total volume of 5ml. The solution is delivered via a standard jet nebulizer over approximately 15-20minutes. This intervention is given once at the time of enrollment in the emergency department, in addition to standard asthma care. The ketamine used is in injectable solution form (typically 50 mg/mL concentration), drawn and diluted immediately prior to nebulization. Participants are monitored continuously for 60 minutes after administration to assess changes in peak expiratory flow rate (PEFR), symptom relief, and adverse events. The goal is to evaluate the bronchodilatory effect and safety of nebulized ketamine in adults with moderate to severe asthma exacerbation who present to the emergency department.

  • DrugPlacebo nebulization (5 mL normal saline) plus standard asthma care

    \*\*Intervention Description (Control Group):\*\* Participants in the control group will receive a single nebulized dose of 5 mL of 0.9% normal saline, delivered using a standard jet nebulizer over approximately 10-15 minutes. This placebo intervention is administered once at the time of enrollment in the emergency department, after standard asthma care. Standard care includes repeated doses of nebulized salbutamol and ipratropium, systemic corticosteroids (oral or intravenous), and supplemental oxygen as needed. The placebo solution is identical in appearance and volume to the active ketamine solution used in the intervention group to maintain blinding. All participants will be monitored for 60 minutes after nebulization to assess changes in peak expiratory flow rate (PEFR), symptom relief using a visual analog scale (VAS), and the occurrence of any adverse events.

06

What researchers measure

Primary outcomes

  1. Change in Peak Expiratory Flow Rate (PEFR) from baseline to 60 minutes post-intervention

    PEFR will be measured using a peak flow meter at baseline (0 minutes) and at 60 minutes after administration of the intervention. The change in PEFR will be calculated to assess the intervention effect.

    Time frame: Baseline (0 minutes) and 60 minutes post-intervention

Secondary outcomes

  1. Change in PEFR at 30 minutes

    Time frame: 30 minutes

  2. • Incidence of adverse effects

    Time frame: 60 minutes

  3. Incidence of intravenous magnesium sulfate administration

    The proportion of participants who receive intravenous magnesium sulfate as part of escalation of care after 60 minutes post-intervention.

    Time frame: 60 minutes

  4. Incidence of ICU admission

    The proportion of participants who require transfer to an intensive care unit (ICU) after 60 minutes post-intervention.

    Time frame: 60 minutes

  5. Incidence of endotracheal intubation

    The proportion of participants who undergo endotracheal intubation after 60 minutes post-intervention due to clinical deterioration.

    Time frame: 60 minutes

  6. Incidence of non-invasive ventilation (BiPAP) initiation

    The proportion of participants who require initiation of bilevel positive airway pressure (BiPAP) after 60 minutes post-intervention as part of escalation of care.

    Time frame: 60 minutes

  7. Disposition plan (discharged, admitted, or transferred)

    Time frame: 60 minutes

  8. Length of stay (if admitted)

    Time frame: 60 minutes

  9. Type of admission bed (e.g., ward vs. ICU)

    Time frame: 60 minutes

  10. Change in dyspnea severity as measured by the Visual Analogue Scale (VAS)

    Patient-reported breathlessness will be assessed using the Visual Analogue Scale (VAS), a 10-centimeter horizontal line ranging from 0 to 10. A score of 0 represents "no breathlessness," and a score of 10 represents "worst imaginable breathlessness." The change in VAS score from baseline to 60 minutes post-intervention will be recorded.

    Time frame: 60 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Aug 2029, 39 months after the start.

Of 61 non-industry phase 2 interventional studies under Asthma, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 62. This study's planned 39 months is below that.

Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 12 and three quarters within 41.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → May 2026, on Oct 19, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2025
First posted
Aug 8, 2025
StartActual
May 30, 2026was Sep 2026
Primary completionEst.
Aug 31, 2029
CompletionEst.
Aug 31, 2029
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 19, 2026
Sites
1 site added — first site in Oman
Show site
  • Sultan Qaboos University Hospital · Muscat, Oman
Oct 19, 2026
Start date
Sep 1, 2026→May 30, 2026 (actual)
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Oman
    Show site
    • Sultan Qaboos University Hospital · Muscat, Oman
    Start date Sep 1, 2026→May 30, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07112456
Lead sponsor
Oman Medical Speciality Board
Responsible party
Al Mahanad Al Julandani (Emergency Medicine Resident Doctor, Oman Medical Speciality Board) — Principal investigator
First posted
Aug 8, 2025
Start date
May 30, 2026
Primary completion
Aug 31, 2029 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Oct 19, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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