New Performance Markers of Ciclesonide Aqueous Nasal Spray for Seasonal Allergic Rhinitis

Web Exclusives
Richard Hyer

Eli O. Meltzer, MDTwo post-hoc analyses of data on patients with allergic rhinitis (AR) have uncovered new performance markers for ciclesonide aqueous nasal spray (CIC-AQ), said lead investigator Eli O. Meltzer, MD, of the Allergy and Asthma Medical Group and Research Center, San Diego, at ACAAI 2010.

Both analyses were based on data from a double-blind, placebo-controlled, multicenter efficacy and safety study of 327 patients aged ≥12 years with seasonal AR (Ratner PH, et al. J Allergy Clin Immunol. 2006;118:1142- 1148). The patients received 200 μg of CIC-AQ (n = 164) or placebo (n = 163) once daily in the morning for 28 days.

Correlation between Nasal Smptoms and Quality of Life
The first analysis evaluated the correlation between improvement in reflective total nasal symptom score (rTNSS) and instantaneous TNSS (iTNSS) and rhinoconjunctivitis-related quality of life as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Patients with seasonal AR were treated with CIC-AQ 200 μg once daily or with placebo.

“The correlation analysis showed improvement in the reflective total nasal symptom scores and in the instantaneous total nasal symptom scores, so it [CIC-AQ] had a long duration of action,” Dr Meltzer said. “These 2 related very well—0.9%—a correlation coefficient which is really quite high.”

Two post-hoc correlation analyses were performed. The first was in patients with baseline rTNSS (ie, moderate severity) or iTNSS ≥6; patients were divided to CIC-AQ (n = 137) or to placebo (n = 132). The other analysis was in patients with baseline rTNSS ≥6 and RQLQ ≥3 (also moderate severity); patients were randomized to CICAQ (n = 119) or to placebo (n = 110).

Patients with baseline rTNSS and iTNSS ≥6 were divided into 2 groups—CIC-AQ 200 μg once daily versus placebo. Patients with baseline rTNSS ≥6 and RQLQ ≥3 were also divided into similar treatment groups.

Improvement in rTNSS was highly correlated with improvement in iTNSS, regardless of treatment group. However, improvement in rTNSS was more correlated with improvement in RQLQ in the CIC-AQ group than in the placebo group.

Dr Meltzer said that the correlation between rTNSS and RQLQ was especially important to him as a clinician. “So as patients improved in their symptoms, they also improved in these other aspects, like feeling thirsty, feeling tired, eye symptoms, their ability to participate in activities, their emotions—those were improved as well,” he said. “So there was a good correlation: symptom improvement with quality-of-life improvement.”

Dr Meltzer added, “Clearly the studies showed the people on ciclesonide did better than the placebo group….And although there’s some improvement in the placebotreated group, because placebo does amazing things, clearly there’s a much greater improvement in the ciclesonide-treated group; both from the symptom standpoint (both reflective and instantaneous) and the quality of life.”

Improvements in Nasal Congestion with CIC-AQ versus Placebo
The second analysis measured changes at 14 days in the 44 patients with baseline nasal congestion scores of <2 (CIC-AQ, n = 21; placebo, n = 23), and in the 280 patients with scores ≥2 (CIC-AQ, n = 141; placebo, n = 139) with CIC-AQ versus placebo. Both groups showed improvements with CIC-AQ 200 μg once daily compared with placebo, but the improvements were greater in those with scores ≥2 in the baseline nasal congestion group. The improvements (mean change from baseline) in the <2 congestion group were CIC-AQ = –0.48 versus placebo = –0.19 (P = .052). Greater im prove ments were seen in the ≥2 congestion group: CIC-AQ = –0.59; placebo = –0.35 (P<.001) after 14 days of treatment

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