None listed
Conditions
Brief summary
Asthma is a major health problem globally. Clinical research and management mainly focus on moderate to severe asthma, however most adults with asthma have mild disease. Short Acting Beta Agonist (SABA) reliever therapy alone is currently the internationally recommended treatment in mild asthma. However, there is substantial morbidity in this population and previous studies have shown that those with intermittent or mild persistent asthma who were Inhaled Corticosteroid (ICS) free experienced severe exacerbations. Evidence suggests that a combination Inhaled Corticosteroid/ Long Acting Beta Agonist (ICS/LABA) inhaler used as reliever therapy may be preferable to SABA only reliever therapy and represent an alternative to maintenance ICS and SABA reliever therapy. The major advantage of the combination ICS/LABA as needed over SABA monotherapy is the ICS therapy is being self-titrated according to symptoms in a group of patients that would not otherwise receive ICS. It may improve adherence to ICS use and enable high dose ICS therapy to be promptly delivered by patients with worsening asthma. We are therefore investigating the safety and efficacy of 3 treatment regimens in mild asthma: 1. A combination inhaled corticosteroid (ICS) and Long Acting Beta Agonist (LABA) as required 2. SABA only as required 3. Regular ICS maintenance, and SABA as required.
Interventions
Inhaled Corticosteroid/Long Acting Beta Agonist (ICS/LABA) reliever therapy; budesonide/formoterol Turbuhaler 200/6 micrograms, one inhalation for relief of symptoms as required, 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 with: a. Self-reported use of a SABA on greater than or equal to 2 occasions in the previous 4 weeks but on average equal to or less than 2 occasions per day in the previous 4 weeks, if there have been no severe exacerbations in the last 12 months, or b. Self-reported use of a SABA on average equal to or less than 2 occasions per day in the previous 4 weeks, if there has been a history of a severe exacerbation in the last 12 months. 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 General Practitioner and/ or consultant, if appropriate, to be notified of participation in the trial.
Exclusion criteria
Self-reported use of Inhaled Corticosteroid, Long Acting Beta Agonist, leukotriene receptor antagonist, theophylline, anticholinergic agent or cromone as regular maintenance therapy in the 3 months before potential study entry. Note nasal corticosteroid therapy is permitted. Self-reported past admission to the Intensive Care Unit (ICU) with life-threatening asthma (patients at highest risk of adverse asthma outcomes). Self-reported hospital admission for asthma in the 12 months before potential study entry (patients at highest risk of adverse asthma outcomes). Self-reported treatment with oral prednisone in the six weeks before potential study entry, representing recent unstable asthma. A home supply of prednisone for use in worsening asthma. Self-reported diagnosis of Chronic Obstructive Pulmonary Disease (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 greater than or equal to 10 pack year history. Self-reported current pregnancy or breast feeding at the time of enrolment or planned pregnancy within the study period. Self-reported congestive heart failure, unstable coronary artery disease, atrial fibrillation or other clinically significant cardiac disease. 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. Self-report of participation in another research trial involving an investigational product, in the past 12 weeks. An on treatment FEV1 less than or equal to 50% of predicted at Visit 1 (predicted values must be calculated using the Global Lung Function Initiative equations). Any known or suspected contraindications to the Investigational Medicinal Products or excipients.
Outcome results
None listed