Comparison of high dose versus low dose salbutamol in acute adult asthmatics presenting to the Emergency Department.

A non-inferiority comparison of low versus high salbutamol dosing regimens via MDI in mild to moderate exacerbations of asthma in adults presenting to the emergency department: a randomized controlled trial.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000397213

Enrollment

Registered

2018-03-20

Start date

2019-08-01

Completion date

2021-03-02

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Despite extensive standard practice of the use of salbutamol in the treatment of acute asthma exacerbations, it is unclear how much should be given. This ambiguity has led clinicians to often give more than required salbutamol doses due to a perceived better outcome with higher doses. This can lead to multiple unpleasant side effects and reduces the tolerability of the treatment amongst patient groups. We are carrying out a blinded randomised controlled trial to compare a higher dose against a lower dose of salbutamol in acute asthma presentations to the emergency department. We aim to compare several outcomes in both groups, including improvement in lung function, length of hospital stay, rates of admission to hospital and adverse events. This is a non-inferiority study and we hypothesise that there will be no difference in outcome in both groups.

Interventions

Salbutamol administered via 100mcg actuation MDI and spacer. 10 puffs every 20minutes over 1 hour. This will be monitored by the trial investigator.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

• Doctor diagnosis of asthma • Age 18 to 65 years • Presentation to ED with a mild- moderate asthma exacerbation • PEF 50 to 75% of predicted • Concomitant asthma medication may include: none, ICS, ICS/LABA, theophylline, LTRA, oral steroids, sodium cromoglycate, nedocromil sodium

Exclusion criteria

• Inability to perform spirometry • Requirement for Non-invasive ventilation (NIV) or intubation • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

Outcome results