None listed
Conditions
Brief summary
The Global Initiative for Asthma (GINA) has established internationally accepted diagnostic and management strategies which aim to achieve optimum asthma control for individual patients however, numerous surveys in NZ and internationally show low adherence to guidelines, suboptimal management, and preventable morbidity. A number of factors contribute to this largely preventable morbidity in intermittent and mild persistent asthma. The most important are failure to prescribe inhaled corticosteroids (ICS) and poor adherence with them.. Since 2014, the GINA guidelines have recommended that most patients with asthma should be prescribed ICS as first line regular maintenance therapy.This recommendation is based on the evidence that the regular use of ICS reduces symptoms, improves lung function, reduces severe exacerbations, prevents hospital admissions, and reduces the risk of mortality. The benefits of ICS in clinical practice are limited by poor adherence which is not surprising as patients are required to take twice daily treatment regardless of whether they have symptoms. This is an important issue as poor ICS adherence contributes to asthma treatment failure, resulting in increased morbidity, risk of mortality, and consumption of healthcare resources. A symptom-based ICS/LABA combination inhaler regimen is appealing because it couples ICS and LABA use to automatically ensure adherence to ICS. This has the potential to improve the frequency of daily ICS use in patients with symptomatic asthma, and to lead to a rapid increase in use during worsening asthma. We are therefore investigating the safety and efficacy of 2 treatment regimens in mild asthma: 1. A combination inhaled corticosteroid (ICS) and Long Acting Beta Agonist (LABA) as required 2. Regular ICS maintenance, and SABA as required
Interventions
Inhaled corticosteroid/Long acting beta Agonist (ICS/LABA) reliever therapy; budesonide/formoterol turbuhaler 200micrograms/6micrograms taken one inhalation for relief of symptoms as required for 52 weeks. These participants will receive no maintenance therapy.
In the electronic monitor sub-study, 110 patients will have an electronic monitor incorporated into each turbuhaler device to record the date and time of actuations to allow a detailed assessment of patterns of use of randomised treatmen
Inhaled corticosteroid/Long acting beta Agonist (ICS/LABA) reliever therapy; budesonide/formoterol turbuhaler 200micrograms/6micrograms taken one inhalation for relief of symptoms as required for 52 weeks. These participants will receive no maintenance therapy. In the electronic monitor sub-study, 110 patients will have an electronic monitor incorporated into each turbuhaler device to record the date and time of actuations to allow a detailed assessment of patterns of use of randomised treatments. 55 participants will be recruited from the ICS/LABA reliever group and 55 participants from the maintenance ICS and SABA reliever therapy group. This substudy will run for 52 weeks. Inhaler use will be monitored electronically. An electronic monitor device will be attached to each inhaler, which is able to measure the date and time of each actuation performed.
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
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 18 to 75 years. Self-report of a doctor’s diagnosis of asthma. Not used Inhaled corticosteroids in the 12 weeks prior to entry into the study and suffering from asthma symptoms or Need for SABA on two or more occasions in the last 4 weeks, or Waking due to asthma once or more in the last 4 weeks, or Exacerbation requiring oral corticosteroids in the last 52 weeks Or has used inhaled corticosteroids in the 12 weeks prior to entry in the study, and is prescribed ICS at low or moderate doses (<500micrograms/day fluticasone propionate or small particle formulation beclomethasone diproprionate (QVAR); 800 micrograms/day budesonide; 1,000 micrograms/day beclomethasone diproprionate (Beclazone)), and: i. has partly or well controlled asthma as defined by GINA guidelines OR ii. has uncontrolled asthma as defined by GINA guidelines and either poor adherence to ICS and/ or unsatisfactory inhaler technique. Willing and able to give informed consent for participation in the trial. In the investigator's opinion, able and willing to comply with all trial requirements. Willing to allow their GP (and specialist if appropriate) to be notified of participation in the trial.
Exclusion criteria
Self-reported use of LABA, leukotriene receptor antagonist, theophylline, anticholinergic agent or cromone as maintenance therapy in the 12 weeks before potential study entry. Nasal corticosteroid therapy is permitted. Self-reported past admission to the Intensive Care Unit (ICU) with life-threatening asthma (representing patients at highest risk of adverse asthma outcomes). Self-reported treatment with oral prednisone or other systemic corticosteroids in the six weeks before potential study entry (representing recent unstable asthma). A home supply of prednisone for use in worsening asthma, as part of a current asthma plan. Self-reported diagnosis of COPD, bronchiectasis or interstitial lung disease. Self-reported greater than 20 pack year smoking history, or onset of respiratory symptoms after the age of 40 years in current or ex-smokers with more than or equal to a 10 pack year history. Self-reported current pregnancy or breast feeding at the time of enrolment or planned pregnancy within the study period. Unwilling or unable to switch from current asthma treatment regimen. Other illness(es) likely to compromise participant safety or impact on the feasibility of results, at the discretion of the investigator (examples include unstable coronary disease and malignancy).
Outcome results
None listed