Real-world use of inhaled corticosteroid/formoterol as-needed in adults with mild asthma: The PRIME study

Inhaled corticosteroid/formoterol fumarate (ICS/FF) as-needed is recommended by the Global Initiative for Asthma as sole therapy in adults with mild asthma, with low-dose maintenance ICS plus short-acting β2-agonist (SABA) as an alternative. SABA alone is no longer recommended. Given these changes in recommendations, the observational PRIME study aimed to describe real-world treatment patterns in mild asthma in Europe.Adults with asthma receiving low-dose maintenance ICS, or as-needed ICS/FF or SABA were followed for 6 months. Data collected included Asthma Control Test (ACT), Asthma Control Questionnaire 5 item (ACQ-5), forced expiratory volume in 1 s (FEV1), and asthma exacerbations.The study was conducted in Germany, Italy, Poland and Spain, in 883 patients; 833 (94.3%) completed follow-up. At enrolment, 32.2% received maintenance ICS, 56.3% ICS/FF as-needed, and 11.6% SABA as-needed; 57.4%, 61.3%, and 54.9%, respectively, had well controlled asthma (ACQ-5/ACT definition). After 6 months, changes in mean FEV1were small in the maintenance ICS and ICS/FF as-needed groups, whereas there was a decline in FEV1in the SABA as-needed group. ACQ-5 total score improved from baseline in all three groups; 0.4%, 0.4% and 2.0% patients, respectively, had a severe exacerbation during the study.More patients received ICS/FF as-needed than SABA as-needed, suggesting that physicians are aware of the latest treatment recommendations. This real-world study provides additional support to the use of ICS/FF as-needed as preferred treatment for patients with mild asthma, whereas SABA as-needed was associated with a fall in lung function and more severe exacerbations.