Which is the most effective therapy to reduce asthma attacks — single maintenance and reliever therapy (SMART) or patient-activated reliever triggered ICS (PARTICS) therapy? That question is the subject of the upcoming iCARE clinical study by Washington, D.C.-based research nonprofit PCORI.
PCORI recently announced $150 million in funding for multiple new health research studies, some of which will be applied to the iCARE study. The primary focus of the study is to determine the annualized rate of asthma exacerbations as defined by asthma-related hospitalization (or 72 hours of oral or parenteral corticosteroids) over a 16-month period. Specifically, researchers will look at the relative effectiveness of PARTICS versus SMART in relation to frequent nebulizer use, outcomes for each and whether socioeconomic factors affect the relative effectiveness of PARTICS and SMART. This will include a look at differential cost and availability of the two therapies, patients’ reluctance to change medications, perceived difficulty in using the two and side effects for each.
Asthma attacks can require visits to urgent care and emergency rooms, hospitalizations and can result in death. Asthma treatment guidelines recommend combining inhaled corticosteroids (ICS) with long-acting beta-agonist (LABA) inhaled medications for quick relief.
The two-arm, randomized, parallel-group, unblinded iCARE study will take data from 21 specialty, family medicine and general internal medicine practices of people ages 18 to 75 with an asthma diagnosis for at least one year, who have been prescribed ICS/LABA and have had an exacerbation within the previous 12 months. Approximately 25% of the population represents Black individuals. The study team will collect information on health literacy, perceived discrimination, smoking status, ICS dosage used in the ICS/LABA combination, use of other asthma medications and self-reported race and ethnicity.
To date, SMART has not been studied in Black or Hispanic and Latino adults and has not been tested in patients who use the nebulized form of albuterol. Studies showing the efficacy of SMART were conducted with an inhaler delivery device not approved in the United States.
PARTICS is a strategy in which patients are told to use an ICS metered dose inhaler (MDI) each time they use their rescue inhaler. In addition, they are instructed to take five puffs of ICS MDI whenever they use their nebulizer for quick relief. Although PARTICS has been shown to reduce exacerbations and improve asthma control and quality of life, questions remain about whether PARTICS is as effective as SMART.
