Time-of-Day Predominance of Allergic Rhinitis Symptoms during Treatment with Intranasal Ciclesonide 200 mcg qd

Abstract

Objectives:

(1) Effectiveness of intranasal ciclesonide 200 mcg qd (CIC). (2) Time-of-day predominance (TDP) of nasal and nonnasal AR symptoms. TDP is the main focus of this report.

Methods:

Phase IV, open-label, noninterventional study. Patients aged 12 years with at least a 2-year history of AR were eligible; 1526 patients with active AR were enrolled and received CIC during 4 weeks. TDP was recorded by patients and classified as: Morning, noon, afternoon, night or none. TDP was evaluated at T0 (basal), once daily during the first treatment-week, and once a week during the rest of the study (weeks 2 to 4). Relative frequencies of AR symptoms were calculated with corresponding 95% confidence intervals. Differences between basal TDP-relative frequency and at treatment-days 7 and 28, were calculated using z test.

Results:

All symptoms were of morning predominance at baseline, for example, runny nose 51%, nasal congestion 51%, sneezing 49%. Morning predominance remained the highest for all evaluated symptoms during CIC-treatment period, but its frequency decreased after 7 and 28 treatment-days; as a result, the no-predominance category increased in frequency during the follow-up. Symptoms showed relative lower probability density after treatment as compared with basal evaluation: Between 0.53 and 0.57 at treatment day 7, and between 0.34 and 0.38 at day 28. All P values (z test) were <.001.

Conclusions:

In this study, TDPs for individual AR symptoms are described in a Mexican population. Treatment with CIC helps to reduce morning predominance of AR symptoms, and increases the asymptomatic state after 4 weeks of treatment.