Investigational Ciclesonide HFA Safe and Effective for Seasonal Allergic Rhinitis

Web Exclusives
Richard Hyer

Nasal congestion, sneezing, itching, and rhinorrhea are all characteristic of allergic rhinitis (AR). Results of 2 current studies with a total of 1260 patients with seasonal AR showed that the investigational nasal aerosol ciclesonide hydrofluoroalkane (CIC-HFA)—delivered via metered dose inhaler—is safe and very effective for treating these symptoms.

Both were randomized, phase 3, placebo-controlled, double-blind, parallel- group, multicenter studies of the drug in 2 doses—80 μg and 160 μg. One study compared CIC-HFA’s efficacy and safety versus placebo; the other study evaluated the drug’s specific effect on rhinoconjunctivitis-related quality of life.

“This is an alternative delivery system for allergic rhinitis,” said Shailesh Desai, PhD, a researcher with Sunovion Pharmaceuticals. “This is a drier, alcohol- based formulation. Contrary to the old CFCs [chlorofluorocarbons] that were there in the market, we have very low incidences of nasal serious adverse events and low incidences of epistaxis [with HFA].”

Safety and Efficacy
The first study consisted of a 14-day treatment period in 707 patients (aged ≥12 years) with a history of seasonal allergies to mountain cedar pollen. Eligibility criteria were a minimum cumulative patient-assessed reflective total nasal symptom score (rTNSS) of 47 (maximum 84) and reflective score for runny nose or nasal congestion of at least 10 (maximum 21).

Patients were randomized to CICHFA 80 μg, CIC-HFA 160 μg, or to placebo. The primary end point was change from baseline in patient-reported morning and afternoon rTNSS. Secondary end points were morning and afternoon instantaneous TNSS (iTNSS) and individual morning and afternoon reflective and instantaneous nasal symptom scores of nasal congestion, runny nose, sneezing, and nasal itching.

Demographic and baseline characteristics were similar across the treatment groups, as were mean baseline rTNSSs (range, 9.10-9.46). Baseline iTNSS ranged from 8.61 to 8.94.

Improvements in Total Nasal Symptom Scores
Both CIC-HFA treatment groups demonstrated significant improvements (P <.001) in total reflective and instantaneous nasal scores from baseline compared with placebo, averaged over the 2-week period.

The daily improvement in rTNSS and iTNSS was consistent over the 2- week double-blind treatment period.

Both treatment groups demonstrated improvements in individual reflective and instantaneous nasal symptom scores of runny nose, itchy nose, sneezing, and nasal congestion.

The overall incidence of treatmentemergent adverse events was low, with 58 events (24.7%) in the placebo group compared with 51 (21.5%) in the 80-μg treatment group and 44 (18.7%) in the 160-μg treatment group. The investigators characterized these as mostly mild or moderate. All events of epistaxis were resolved without intervention, and no nasal septal perforations were reported.

Effect on Rhinoconjunctivitisrelated Quality of Life
The second trial measured the ability of CIC-HFA to improve the rhinoconjunctivitis-related quality of life associated with seasonal AR, as evaluated by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) with standardized activities in patients aged ≥12 years. Lead investigator, Dale Mohar, MD, of Kerrville Research Associates, TX, presented this study.

The study design and treatment period matched those of the first study. Patients were eligible if they had a history of seasonal AR to mountain cedar pollen for ≥2 years immediately preceding the study. The 2 treatment groups were similar to those in the first study and were compared with placebo.

The primary and key secondary efficacy end points were change from baseline in patient-reported morning and afternoon rTNSS, iTNSS, and reflective total ocular symptom score. (See also article on ocular symptoms, this page.) Rhinocon junctivitis-related quality of life measured by RQLQ with standardized activities was evaluated as one of the secondary end points. “With the HFA, we are showing that it does relieve ocular symptoms as well,” Dr Desai commented on the results of this study.

Change in overall RQLQ with standardized activities scores was calculated for the intent-to-treat population, as well as for patients with baseline RQLQ with standardized activities scores ≥3 as defined a priori in the statistical analysis protocol. The RQLQ with standardized activities was self-administered by patients at baseline and at the end of the study medication period.


In patients with baseline RQLQ ≥3, the 80-μg (n = 187) and 160-μg (n = 183) treatment groups demonstrated improvement, as seen in the Table.

The overall RQLQ for the 80-μg group was –1.05 versus –0.42 for placebo (n = 183), a significant difference (95% confidence interval [CI], 0.36- 0.89; P <.001). For the 160-μg group, the overall RQLQ was –1.07, a significant difference (95% CI, 0.37-0.91; P <.0001) versus placebo.

Commenting on these results, Dr Mohar said, “You don’t often see patients citing improvements that are almost triple or more than triple placebo.” He cited the individual RQLQ domain of “activities,” where the change from baseline was –0.96 over placebo’s –0.28—a significant difference (95% CI, 0.40-0.97; P <.001), crediting the aerosol formulation of ciclesonide for this improvement.

Patients in both groups demonstrated improvements in individual domains, including activities, sleep, practical problems, nasal and eye symptoms, and emotions

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