None listed
Conditions
Brief summary
The recommended treatment for preventing asthma exacerbations in adults with moderate-severe asthma is regular inhaled corticosteroids (ICS) combined with an inhaled long-acting beta-agonist drug (LABA). This therapy is commonly prescribed as a fixed combination inhaler, such as Seretide (Registered Trademark), Symbicort (Registered Trademark) or Vannair (Registered Trademark) and is taken twice daily with a short-acting beta-agonist (SABA) used as rescue therapy in the event of an exacerbation ("STANDARD" regime). An alternative regime in which patients take their Vannair (Registered Trademark) combination inhaler both as Maintenance And Reliever Therapy (referred to as SMART) has recently been proposed. A large clinical trial programme has shown that Symbicort (Registered Trademark) (budesonide/eformoterol) taken according to the SMART regime is more effective than the STANDARD regime. However, these studies were undertaken under strict clinical trial conditions in highly selected populations. Additionally it is not clear how the use of budesonide/eformoterol given according to the SMART regime improves outcomes, or whether its use by patients in the situation of worsening asthma or severe exacerbations is associated with significant risk. This study aims to assess the effect on asthma control of budesonide/eformoterol given using the SMART regime in a population of high-risk asthmatics in real life and to measure (using electronic monitoring devices) the actual use of budesonide/eformoterol when used according to the SMART regime.
Interventions
The intervention is inhaled budesonide/eformoterol (Vannair (Registered Trademark) 200/6 micrograms) two actuations taken twice daily and as required for asthma symptom relief as per the "SMART" (Single combination inhaler as Maintenance And Reliever Therapy) regime. The duration of the intervention is 24 weeks. There is no subsequent follow-up period planned.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. A doctor's diagnosis of asthma; 2. A current prescription for inhaled corticosteroid (ICS) medications; 3. No change in the dose of ICS in the last month; 4. An asthma exacerbation in the previous year where the patient presented to a General Practitioner or Emergency Department and was prescribed a course of oral steroids and/or received a spacer/nebuliser-delivered bronchodilator and patients who self-administered prednisone for asthma for at least 3 days.
Exclusion criteria
1. Onset of respiratory symptoms after the age of 40 years in current or ex-smokers with a greater than or equal to 10 pack years smoking history; 2. use of an at-home nebuliser (unless patients agree to withhold nebuliser use for the study duration); 3. treatment with oral prednisone in the previous 4 weeks; 4. diagnosis of Chronic Obstructive Pulmonary Disease (COPD), interstitial lung disease or bronchiectasis; 5. unsuitable cardiovascular or other medical history, or any other safety concern at the investigator's discretion; 6. unable or unwillling to give consent to participate, to follow the study requirements and/or to change from current asthma treatment regime.
Outcome results
None listed