Omnaris ciclesonide nasal spray use
January 20 2017 by Ray Sahelian, M.D.
Omnaris (ciclesonide) nasal spray is a new drug for the
treatment of nasal symptoms associated with seasonal and perennial
rhinitis, commonly known as hay fever, in adults and children 12 years of age
Allergic rhinitis is the medical term for the inflamed, runny nose that's the
main symptom of allergies. Seasonal allergic rhinitis is the most common
allergic disease. About 35 million Americans suffer from this condition. The
ailment’s classic symptoms are watery nasal discharge, and fits of sneezing, and
itching that can affect not just the nose but the roof of the mouth, throat and
the Eustachian tubes which connect the middle ear to the back of the throat.
Although the precise way Omnaris works is unknown, the drug is a corticosteroid.
Corticosteroids are hormone-like drugs that suppress the immune response.
The safety and efficacy of Omnaris nasal spray were studied in four randomized placebo controlled clinical trials ranging in duration from two weeks to a year. The studies assessed how well Omnaris treated symptoms (runny nose, nasal itching, sneezing, and nasal congestion) in patients with hay fever. The results of these trials showed that patients treated with Omnaris nasal spray had an 8-10 percent greater reduction in nasal symptoms compared to placebo. The difference between Omnaris nasal spray and placebo was significant.
Asthma treatment for improved breathing
Tanaffos. 2015. Efficacy of Low-Dose Ciclesonide and Fluticasone Propionate for Mild to Moderate Persistent Asthma. The aim of this study was to compare the efficacy of ciclesonide (80 mg/day) and fluticasone propionate (200 mg/day) for mild to moderate persistent asthma. Omnaris at a dose of 80 μg once daily can provide efficient maintenance therapy for mild to moderate persistent asthma.
Prescrire Int. 2013. Ciclesonide: long-term treatment of
persistent asthma--no clear progress. Inhaled corticosteroids such as
beclometasone are the drugs of choice for long-term treatment of patients with
persistent asthma. There is no tangible difference in efficacy among inhaled
corticosteroids, but we have the most experience with beclometasone. Ciclesonide
(Alvesco, Nycomed then Takeda), another inhaled cortico-steroid, has been tested
in three double-blind trials versus budesonide and six trials versus fluticasone
but none versus beclometasone. These trials showed the "non-inferiority" of
ciclesonide, mainly in terms of a surrogate endpoint: the change in forced
expiratory volume in one second (FEV1) after 12 or 24 weeks of treatment
(primary endpoint). However, the doses of ciclesonide used in these trials were
higher than the standard doses while doses of the comparator corticosteroids
were lower than the standard doses, thus favouring ciclesonide. Local adverse
effects of inhaled corticosteroids include oral candidiasis, sore throat and
hoarseness. A systematic review conducted by a Cochrane group suggests that
ciclesonide does not have a better adverse effect profile than other inhaled
corticosteroids used at equivalent doses. Corticosteroid inhalation can also
lead to systemic absorption. The practical advantage of once-daily dosing with
ciclesonide seems minor. In practice, ciclesonide is neither more effective than
the inhaled corticosteroids with which it has been compared, nor does it have
fewer adverse effects. It is better to continue to use beclometasone, a drug
with which there is more experience.
Omnaris side effects, safety
The most common Omnaris side effects in clinical studies were headache, nosebleeds, and inflammation of the nose and throat linings.
Omnaris is manufactured by ALTANA Pharma US, Inc. of Florham Park, NJ.