Reference: J Allergy Clin Immunol Pract. 2021 Mar;9(3):1365-1373
Spring is in the air—can you smell it? Maybe not, considering 10-30% of the population suffers from the sneezing and rhinorrhea associated with seasonal allergies and allergic rhinitis. Climate change has led to warmer, earlier springs and higher pollen levels. The effects of climate change on seasonal allergies may be obvious, but perennial allergic rhinitis (PAR) is becoming more common in tropical and subtropical countries as well. This means more allergic symptoms and more need for (hopefully evidence-based) treatment of these symptoms. Once-daily intranasal corticosteroid (INCS) treatment is the recommended first-line therapy for all types of allergic rhinitis, with maximal benefit seen after several days of use. A new study, however, investigated whether prn use of intranasal fluticasone furoate (FF) can provide similar benefit to daily use.
Researchers randomized 108 adults (mean age 30 years, 74% female) with moderate-to-severe persistent PAR. Both groups participated in a 4-week washout of no therapy and had to have (by report) at least moderately severe symptoms at the end of this period to qualify. They were then given one week of scheduled daily FF nasal spray. After one week of use, the control group continued with daily scheduled FF use while the other was instructed to only use the spray as needed. Outcome assessors were blinded to group assignment but participants were not. Total nasal symptoms scores (TNSS) were logged daily along with nasal peak inspiratory flow (NPIF) twice daily for six weeks. Follow-up occurred via clinic visits at weeks 1, 4, and 6. The primary outcome was mean change in TNSS between groups.
No statistically significant differences in TNSS were found between treatment groups based on intention-to-treat analysis (p=0.066). Breaking down the TNSS, there was greater improvement in nasal congestion and sneezing scores at week 6 in the FF-scheduled group (p=0.049, p=0.013 respectively). The FF-scheduled group also had a greater mean improvement in NPIF at 6 weeks (p=0.009). There was similar improvement in both groups in Rhinoconjunctivitis Quality of Life-36 Questionnaire scores. The FF-as-needed group used 51% of the mean cumulative FF dose used by the FF-scheduled group.
So is the bottom line that prn INCS works as well as daily use for perennial allergies as the authors suggest? Outcomes between groups at week one were nearly identical, as expected, because both groups were instructed to use FF daily for that first week, essentially creating a run-in period. One could argue the initial benefit of “usual” prn use could be overestimated in this model of prescribing (which is not purely prn), or at least that this was an inappropriate comparison. This argument is bolstered by the waning benefit of prn INCS in terms of sneezing and nasal congestion at 6 weeks compared to daily use. A larger trial may detect a difference in primary outcome. Perhaps a non-inferiority trial design would be a better choice since we already have trial data showing that fluticasone works. At the end of the day, we are treating symptoms, not saving lives. Considering how hard it is to convince asymptomatic patients to take medications, maybe we should just educate patients that prn use is a reasonable option if it controls their symptoms to their own degree of satisfaction.
For more information, see the topic Allergic Rhinitis in DynaMed.
DynaMed EBM Focus Editorial Team
This EBM Focus was written by Nicole Jensen, MD, Faculty Development Fellow and Clinical Instructor of Family Medicine at the University of Virginia. Edited by Alan Ehrlich, MD, Executive Editor at DynaMed and Associate Professor of Family Medicine at the University of Massachusetts Medical School; Dan Randall, MD, Deputy Editor for Internal Medicine at DynaMed; Carina Brown, MD, Assistant Professor at Cone Health Family Medicine Residency; and Katharine DeGeorge, MD, MS, Associate Professor of Family Medicine at the University of Virginia.