None listed
Conditions
Brief summary
Targeting peripheral airway dysfunction with small particle bronchodilator in asthma This study aims to determine whether the small airways, a site of physiological dysfunction in asthma, can be targeted with bronchodilator therapy, by using a small particle size aerosol that reaches the lung periphery. Current clinical management of patients with asthma includes an array of inhaled therapies. However, there is no consensus relating to the efficacy of different particle sizes for inhalation, despite particle size being the main determinant of where the drug deposits in the airway. Participants with asthma will be invited to participate in two study visits. Both study visits will involve physiological assessments (lung function tests) and ventilation scans completed at baseline and post-bronchodilator. At one visit the standard medication salbutamol will be administered via a conventional vibrating mesh nebuliser (Aerogen solo), at the other visit the salbutamol will be administered via the Aerogen PDAP which will create a fine particle aerosol. The aim is 2 recruit and test 30 participants and compare their response to small and large particle bronchodilator.
Interventions
Study design
This is a cross-over study. All subjects will receive both small and large particle bronchodilator, thereby serving as their own control. They will attend for 2 visits. 1x small particle visit and 1 x large particle visit. Consecutive participants will alternate between small particle first / large particle second and large particle first / small particle second, so that the order will be split equally amongst the cohort. Baseline physiology and response to both large and small part
Study design This is a cross-over study. All subjects will receive both small and large particle bronchodilator, thereby serving as their own control. They will attend for 2 visits. 1x small particle visit and 1 x large particle visit. Consecutive participants will alternate between small particle first / large particle second and large particle first / small particle second, so that the order will be split equally amongst the cohort. Baseline physiology and response to both large and small particle bronchodilator will be assessed for each participant. Bronchodilator administration Bronchodilators act on receptors in the airway to relax the smooth muscle, increasing the airway lumen diameter, and reducing airflow obstruction. Short acting beta-2 agonists (SABA) are fast acting bronchodilators and are used as ‘rescue medication’ on presentation of asthma symptoms. Currently there are many devices that can be used to administer SABA, which deliver particles of different sizes, but there is no consensus on which provides the most therapeutic benefit. Up to a 100µg dose of salbutamol (equivalent of 1 actuation from a metered dose inhaler) will be delivered to the participant in the sitting position from a Aerogen Solo that will deliver the large aerosol and Aerogen PDAP nebuliser that will deliver fine aerosol (intervention). Both the Solo and PDAP are attached to a mouthpiece, through which the participant will inhale the aerosol. They will breath normally until all of the aerosol has been delivered, this will be 1 day apart. Efficacious period for SABA / salbutamol is 4 hours, therefore 1 day is sufficient for washout. Study setting The study site is the Alfred Hospital. The Alfred Hospital is a large, tertiary academic hospital located in Melbourne, Australia, and is part of Alfred Health. Recruitment will be via the Asthma clinic, patients under the management of the Asthma clinic may be invited in person or over the phone to take part. Participant testing and data storage will be onsite at the Alfred hospital.
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Able to provide informed consent to participate in the study • Physician diagnosis of asthma • Evidence of airway dysfunction / suboptimal Asthma control defined as either: recent positive response to salbutamol on spirometry bronchodilator testing (within 6 weeks) or an Asthma Control Questionnaire (ACQ) score >1.5. • 18–60 years of age • Current Non-smokers with <10-year pack history and no smoking for 12 months
Exclusion criteria
• COPD, bronchiectasis, and any other lung disease apart from asthma based on clinical grounds and available HRCT scans • Asthma exacerbation (increase in asthma symptoms >2days resulting in increased SABA +/- ICS or oral steroids) within the previous 6 weeks • Attending emergency department or GP for worsening asthma symptoms in the last 12 weeks • Current smoking (>1 cigarette/day>3months) within the last 12 months, or >10 pack year history of smoking. • Pregnant or breastfeeding • Unable to provide written informed consent • Allergy to salbutamol
Outcome results
None listed