PURPOSE OF THE STUDY:
To compare the effectiveness of as-needed fluticasone furoate (FF) nasal spray (27.5 μg; 2 sprays once daily for 1 week, followed by as-needed use for 5 more weeks) with that of regular use of FF once daily for 6 weeks in patients with moderate to severe, persistent allergic rhinitis.
Patients were at least 18 years of age living in Thailand with year-round allergic rhinitis characterized by symptoms occurring >4 days per week for at least 4 consecutive weeks that impaired daily activities, school or work, sleep, or quality of life. Patients were excluded if they had rhinosinusitis, nasal polyps, significant deviated nasal septum, asthma or chronic lung disease, recent upper respiratory tract infection, or previous allergen immunotherapy. Patients had a mean age of 30 years (SD: 8.4 years) and an average duration of symptoms of 15 years, and 95% were allergic to dust mites.
Outcome assessors were single-blinded in evaluating outcomes of this 2-arm, parallel group randomized controlled trial conducted from October 2017 to June 2019 at a large tertiary care university hospital. The primary outcome evaluated was the total nasal symptom score (TNSS), measured by summing the score of 4 primary symptoms (congestion, rhinorrhea, sneezing, and itching) recorded on a 4-point severity scale from 0 (no symptoms) to 3 (severe symptoms). Secondary outcomes included nasal peak inspiratory flow and rhinoconjunctivitis quality of life-36 questionnaire (RCQ-36). The study was adequately powered (80%) to detect a 0.16 point TNSS treatment difference between groups.
Disease burden, as measured by primary and secondary outcomes, improved in both groups. The intention-to-treat analysis evaluated all of 108 patients randomly assigned, revealing a nonsignificant trend in TNSS improvement for patients with regular FF use (difference: 1.21; 95% CI: −.08 to 2.49; P = .066). Although RCQ-36, nasal itching scores, and rhinorrhea scores were not significantly different between groups, the nasal peak inspiratory flow (difference: −19.2; P = .009), nasal congestion scores (difference: 0.42; P = .049), and sneezing scores (difference: 0.51; P = .13) favored regular use of FF. Notably, the cumulative dose of FF was far lower in the as-needed group than in that of daily groups (difference: 1920 μg; P < .001), and as-needed FF use was associated with a lower rate of acne (2.0% vs 7.7%).
Patients using as-needed FF reported a 49% reduction in cumulative nasal steroid dose over the study period but experienced similar reductions in TNSS and RSQ-36 score.
Previous studies of seasonal allergic rhinitis have revealed improved symptom control with regular, compared with as-needed, use of nasal corticosteroids (NCSs). However, adherence to regular use of NCSs challenges this treatment paradigm in the real-world, where less than one-third of patients regularly use NCS as prescribed. The perfect is not the enemy of the good, and, with this study, the researchers add to a body of literature that as-needed NCS use for allergic rhinitis can be a good option, particularly when considered through a lens of patient-preference–sensitive care and shared decision-making. Although this is not a pediatric study, the issue of adherence and cumulative dose of topical glucocorticoid is highly relevant to children. Considering improvements that are possible with as-needed NCS, this option can be a consideration for children who do not have adequate control with a nonsedating oral or nasal 1H-antihistamine. Still, for patients with inadequate control with an as-needed NCS strategy, regular NCS (with or without a nasal antihistamine) may be even more effective, and additional treatment options, such as specific allergen immunotherapy, remain considerations.