None listed
Conditions
Brief summary
Budesonide/formoterol as a reliever has superior efficacy to SABA reliever therapy in adults with mild asthma reducing the number of severe exacerbations, improving asthma control and reducing airway inflammation. To have confidence in budesonide/formoterol reliever therapy it is necessary to define its onset of action as a bronchodilator as it would be self-administered by patients the community to relieve symptoms. Patient perception that SABA's relieve symptoms better than budesonide/formoterol could be a barrier to asthmatics confidence of budesonide/formoterol for symptom relief which is an important consideration.
Interventions
Intervention arm: Budesonide/formoterol 200/6mcg, one actuation
Spirometry will be condcuted at baseline, 1,2,3,5,10,15 and 30 minutes post dose.
Visual Analogue Score administered at 1,2,3,5,10,15 and 30 minutes post dose
mBORG Scale administered at baseline and 10 minutes.
Total duration will be approximately 1 hour and will be conducted at the Medical research Institute of New Zealand (MRINZ)
The study drugs will be administered by a study investigator and therefore there is no need to moni
Intervention arm: Budesonide/formoterol 200/6mcg, one actuation Spirometry will be condcuted at baseline, 1,2,3,5,10,15 and 30 minutes post dose. Visual Analogue Score administered at 1,2,3,5,10,15 and 30 minutes post dose mBORG Scale administered at baseline and 10 minutes. Total duration will be approximately 1 hour and will be conducted at the Medical research Institute of New Zealand (MRINZ) 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 washout period of 7 days
Sponsors
The Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Self-reported doctor diagnosis of asthma. • Age 18 to 65 years at time of consent. • Allowed asthma treatments are SABA as reliever, regular maintenance ICS therapy together with SABA as a reliever, regular maintenance ICS , LABA with SABA as a reliever or ICS/LABA as a reliever. • FEV1 greater than 50% predicted using the GLI2012 predicted values at the screening visit. • Change in FEV1 within 30 minutes of 200mcg salbutamol being administered must be at least 10% and at least 200ml improvement from baseline in FEV1.
Exclusion criteria
• Other clinically significant respiratory or cardiovascular disorder. • Current or recent respiratory tract infection not resolved within the 4 weeks prior to the randomisation visit. • Current or intermittent use of LTRA therapy, LAMA, SAMA, theophylline, biologics, sodium cromoglycate or nedocromil sodium or non-selective beta blockers within 4 weeks of randomisation. • Asthma exacerbation requiring oral steroids within the 6 weeks prior to the randomistaion visit. • Ex-smokers or current smokers with a history >10 pack years. • Pregnant, or planning a pregnancy, or breast feeding. • Allergy or contraindication to investigational products. • 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. • Unable to perform spirometry. • Unable to use correct inhaler technique at both screening and prior to intervention 1. • Unable to withhold usual asthma medications prior to screening and each intervention.
Outcome results
None listed