Source: DGNews  |  Posted 2 years ago

By Micheal Casasnovas

MIAMI BEACH, Fla -- November 19, 2009 -- Inhaled ciclesonide improved most
asthma control endpoints in patients with mild to moderate asthma and its
effectiveness was not affected whether the patient had a history of allergic
rhinitis, according to a study presented here on November 8 at the American
College of Allergy, Asthma & Immunology (ACAAI) annual scientific meeting.

“Allergic rhinitis may worsen or complicate asthma treatment,” said Edward
Kerwin, MD, Clinical Research Institute of Southern Oregon, Medford, Oregon.
“This post hoc analysis assessed whether asthmatic subjects with a history of
allergic rhinitis or without a history of allergic rhinitis responded
differently to inhaled ciclesonide therapy as assayed by changes in
FEV₁ [forced expiratory volume in 1 second], nighttime
awakenings, rescue albuterol use, and adverse events.”

The 16-week, multinational, multicentre, randomised, double-blind,
placebo-controlled, parallel-group study included patients aged at least 12
years (mean age, 36.7 years), experiencing mild to moderate asthma and not
using inhaled corticosteroids for a month or more before screening.

Patients were randomised to ciclesonide 80 mcg twice a day (n = 170),
ciclesonide 160 mcg once a day (n = 173), ciclesonide 80 mcg twice a day for 4
weeks followed by ciclesonide 160 mcg once a day for 12 weeks (n = 171), or
placebo (n = 177).

Patients were determined to be positive for allergic rhinitis-positive (n =
472) or -negative (n = 219) using previous medical records.

The researchers found improved mean FEV₁ second from baseline to
the average of week 12 and week 16 for allergic rhinitis-positive patients
treated with ciclesonide 80 mcg twice a day, ciclesonide 160 mcg daily,
ciclesonide 80 mcg twice a day for 4 weeks followed by ciclesonide 160 mcg
daily for 12 weeks or placebo, and for allergic rhinitis-negative patients
treated with ciclesonide 80 mcg twice a day and ciclesonide 160 mcg daily (all
P < .02).

FEV₁ was found not to improve for allergic rhinitis-negative
patients treated with ciclesonide 80 mcg twice a day for 4-weeks followed by
ciclesonide 160 mcg daily for 12-weeks or placebo (P >= .19).

Allergic rhinitis-positive and -negative patients had similar reductions in
nighttime awakenings and rescue albuterol use (P values for
difference between allergic rhinitis-positive and allergic rhinitis-negative
>0.2) in all treatment groups.

“The frequency of adverse events was similar across treatment groups and was
not related to the presence or absence of allergic rhinitis,” said Dr. Kerwin.

Allergic rhinitis-positive patients displayed improvement in
FEV₁ from baseline to the average week 12 and week 16 following
all treatments (all P <= .014).

Allergic rhinitis-negative patients displayed improvement in
FEV[_]1[] from baseline to the average week 12 and week 16 following
ciclesonide 80 mcg twice a day and ciclesonide 160-mcg daily therapy (all
P < .004 versus baseline).

“Only ciclesonide 80 mcg twice a day treatment improved flow expiratory volume
greater than placebo [P = .0006],” said Dr. Kerwin.

Researchers observed greater improvements in allergic rhinitis-positive
patients than allergic rhinitis-negative patients following all treatments, and
this was statistically significant following ciclesonide 80 mcg twice a
day/ciclesonide 160 mcg daily therapy (P <= .05).

All treatment groups decreased rescue albuterol use from baseline to week 16
(all P < .0001 versus baseline). Significant reduction in rescue
albuterol use compared with placebo was noted in all ciclesonide treatments,
besides the allergic rhinitis-positive ciclesonide 160 mcg daily treatment.

Funding for this study was provided by sanofi-aventis, Nycomed GmbH, and
Sepracor Inc.

Presentation title: An Examination of the Efficacy of Ciclesonide in
Mild-to-Moderate Asthma Patients With and Without Co-Morbid Allergic Rhinitis.
Abstract P95