None listed
Conditions
Brief summary
Update Currently, when someone goes to the Emergency Department with an asthma attack, they are given are medication called salbutamol (Ventolin). Salbutamol is a rescue inhaler which opens up the airways to make breathing easier. This study looks at what would happen if a different inhaler is used instead of salbutamol. This other combined inhaler is named Symbicort. It contains budesonide (an inhaled steroid medication) and formoterol (a long-acting medicine that opens your airways). This inhaler is currently used by many people with asthma as a preventative inhaler. This means it is used on a daily basis to prevent asthma attacks. In this study, we are looking to see if Symbicort could be used as a rescue inhaler as well, like salbutamol. Participants will first attend a screening visit to decide if they are eligible to take part. If found to be eligible, they then be requested to attend TWO intervention visits upto 4 weeks apart. Participants will receive salbutamol during one visit and Symbicort during the other, in a random order. Both the participant and the study doctor will know which group they are allocated to. During the Intervention visits, participants will undergo spirometry and FeNO testing. They will also have blood samples taken and ECGs done. They will also be asked to rate their levels of breathlessness on a scoring system.
Interventions
Intervention drug schedule: Budesonide/formoterol 200µg/6µg per actuation from the Turbuhaler, 1 actuation at 30 minute intervals for 4 doses over 90 minutes, followed by 2 actuations on 3 occasions at 20 minute intervals for 1 hour, followed by 2 actuations at 7 hours.
The total duration of administration will be 7 hours.
The intervention will take place at the Medical Research Institute of New Zealand (MRINZ) facility. The study drugs will be administered by a study investigator and therefore
Intervention drug schedule: Budesonide/formoterol 200µg/6µg per actuation from the Turbuhaler, 1 actuation at 30 minute intervals for 4 doses over 90 minutes, followed by 2 actuations on 3 occasions at 20 minute intervals for 1 hour, followed by 2 actuations at 7 hours. The total duration of administration will be 7 hours. The intervention will take place at the Medical Research Institute of New Zealand (MRINZ) facility. The study drugs will be administered by a study investigator and therefore there is no need to monitor adherence. An actuation is defined as an 'inhalation or puff from an inhaler'. Due to the cross over design, there will be a minimum washout period of 7 days.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Doctor diagnosis of asthma. Age 16 to 65 years. SABA monotherapy or SABA with regular ICS therapy, or regular ICS/LABA treatment FEV1 40 to 70% predicted as per GLI 2012 criteria Change in FEV1 post 400µg salbutamol via MDI through a spacer >12% increase from baseline, and >200ml
Exclusion criteria
Other significant respiratory disorder Other significant cardiovascular disorder such as history of arrhythmia including atrial fibrillation and supraventricular tachycardia Current or recent respiratory tract infection in last 4 weeks Current use of other asthma medications including LAMAs, theophylline, oral corticosteroids, biologics, sodium cromoglycate or nedocromil sodium Asthma exacerbation requiring oral steroids in last 6 weeks Current smoker or smoking history with >10 pack year history QTCF > 430ms for men and > 450ms for women Pregnant, or planning a pregnancy, or breast feeding Allergy to investigational products, including previous adverse effects following administration of similar doses to those used in the study Current use of beta-blockers Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.
Outcome results
None listed