A study comparing two step-wise treatment tracks for adults with asthma: inhaled corticosteroid with formoterol reliever therapy versus short-acting beta-agonist reliever therapy.
A randomised, parallel group trial comparing two stepwise treatment tracks for the pharmacological management of adult asthma: ICS/formoterol reliever vs SABA reliever-based therapy
Medical Research Institute of New Zealand
152 participants
Apr 11, 2025
Interventional
Conditions
Summary
This is a study comparing two stepwise treatment algorithms that are recommended in the Asthma and Respiratory Foundation NZ and the Global Initiative for Asthma international guidelines to treat asthma. One algorithm uses one inhaler called DuoResp Spriomax that contains both an inhaled corticosteroid (ICS) and formoterol, a long acting beta-agonist (LABA). The other algorithm uses different inhalers that contain ICS (Fluticasone propionate and Fluticasone Furoate), LABAs (Salmeterol and Vilanterol) and short acting beta-agonists (Salbutamol). The inhalers used in this algorithm are called Flixotide Accuhaler (ICS), Seretide Accuhaler (ICS and Salmeterol), Breo Ellipta (ICS and Vilanterol) and Ventolin (Salbutamol). 152 participants will be enrolled for 52 weeks with 5 scheduled visits at 3 monthly intervals. Half the participants will be allocated to algorithm 1, and the other half algorithm 2. Over 12 months participants will attend 3 monthly follow up visits. At these visits the study team will check how well controlled the participants asthma is and may change the participants treatment based on their asthma control. Participants who are well controlled may “step down” the treatment algorithm and people who are poorly controlled may “step up” the treatment algorithm, meaning their inhaled medication type or dose may change. The main outcome of the study is to see how much ICS the participants are exposed to during the 12 months of the study. Other important outcomes are participant satisfaction, changes in lung function and inflammation, and participants overall asthma control
Eligibility
Inclusion Criteria10
- Self-reported doctor’s diagnosis of asthma for greater than 12 months
- Age 16 to 75 years
- Current use (within the last 3 months) of either:
- o SABA reliever monotherapy and the self-reported use of a SABA on greater than or equal to 2 occasions for the relief of asthma symptoms in the previous 4 weeks, excluding before exercise
- o ICS maintenance plus SABA reliever therapy
- o ICS/LABA maintenance plus SABA reliever therapy
- Participant is willing and able to give informed consent for participation in the trial.
- In the Investigator’s opinion, participant is able and willing to comply with all trial requirements.
- In the Investigator’s opinion, participant is able and willing to use all inhaler devices used in study.
- Self-reported registration with a General Practitioner
Exclusion Criteria21
- Current use (within last 3 months) of the following medications:
- o Budesonide/Formoterol anti-inflammatory reliever therapy (AIR)
- o Budesonide/Formoterol Single Maintenance and Reliever Therapy (MART)
- o ICS/LABA maintenance inhaler greater than 500µg Fluticasone Propionate equivalent per day
- o Leukotriene receptor antagonists
- o Short-acting or long-acting inhaled muscarinic antagonists
- o Theophylline
- o Regular oral corticosteroids
- o Sodium cromoglycate or nedocromil sodium
- o Monoclonal antibody therapy
- o Beta-blocker
- Self-reported urgent medical review for asthma, or treatment with systemic corticosteroids such as oral prednisone, in the four weeks before potential study entry.
- ICU admission for asthma (ever).
- Self-reported diagnosis of COPD, bronchiectasis, vocal cord dysfunction 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 than10 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, atrial fibrillation, unstable coronary artery disease, or other clinically significant cardiac disease.
- Participant is unwilling or unable to switch from current asthma treatment regimen.
- Self-report of participation in another research trial involving an investigational product, in the past 3 months.
- Any known or suspected contraindications to the medications prescribed for the study or their respective excipients, including severe milk protein allergy
- 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
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Interventions
This is a randomised, parallel group, single centre, open label study comparing two algorithmic stepwise approaches to the pharmacological management of adult and adolescent asthma. 152 eligible patients diagnosed with asthma aged 16-75 years who in the 3 months prior to enrollment have been prescribed short acting beta-agoinst (SABA) reliever therapy alone, maintenance inhaled corticosteroids (ICS) plus SABA reliever therapy, or maintenance ICS/long acting beta agonist (LABA) plus SABA reliever therapy, will be enrolled and randomised in a 1:1 ratio to the two study arms; Algorithm 1 and Algorithm 2 at Visit 1 (week 1). The algorithm step at randomisation is based on the participants Global Initiative for Asthma (GINA) treatment step at enrollment. Visit one will last approximately two hours. Participants will be followed up at four follow up visits (visits 2,3,4 and 5) every 13 weeks lasting approximately one hour. At follow up visits participants transition between treatment step according to the GINA criteria for asthma control and if they have had a severe exacerbation in the prior 6 months. Patients step up a treatment level at clinic visits in response to a severe exacerbation or uncontrolled asthma (GINA criteria of 3-4/4). Patients step down a treatment level at clinic visits if there has been no severe exacerbation in the last 6 months, and if they have well controlled asthma (GINA criteria 0/4) at the clinic visit. Inventions: Arm 1: • Step 1: lCS/formoterol 200/6µg one actuation as required for the relief of symptoms. • Step 2: Maintenance low dose lCS/formoterol 200/6µg one actuation twice daily plus lCS/formoterol 200/6µg one actuation as required for the relief of symptoms. • Step 3: Maintenance medium dose lCS/formoterol 200/6µg two actuations twice daily plus lCS/formoterol 200/6µg one actuation as required for the relief of symptoms. The cumulative ICS dose will be assessed by inhaler dose counters for Accuhaler, Ellipta and Spiromax devices returned by the participant at each clinic visit. Diary cards and e-monitoring will not be performed.
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ACTRN12624001488594