| 1. Do
patients prefer Rhinocort® over other intranasal corticosteroids? |
A
recent, randomised, crossover study compared patient preference for
Rhinocort® Aqua™ or fluticasone propionate in patients with
mild-to-moderate allergic rhinitis (Shah et al 2003). Single doses
of Rhinocort® Aqua™ 64 µg were compared with
fluticasone propionate 200 µg in the first study and
100 µg in the second study. In each study, for patients
who expressed an overall global preference, Rhinocort® Aqua™
was preferred over fluticasone propionate in 59% and 54% of patients,
respectively, based on the sensory features of the products used
(Shah et al 2003).
Using
recommended starting doses, product sensory attributes perceived by
patients differed significantly (p<0.05) between Rhinocort®
Aqua™ and fluticasone propionate (Figure 1a). In the
second study, using only half the starting dosage of fluticasone
propionate, similar trends were noted, although only ‘scent’
and ‘taste’ showed significant (p<0.001) differences
between treatments (Figure 1b). In
patients who expressed an overall preference, significantly (p<0.05)
more patients preferred Rhinocort® Aqua™ in the first study
(Figure 2a) and a trend was seen in favour of Rhinocort® Aqua™
in the second study, although statistical significance was not
achieved (Figure 2b). The stronger preference for Rhinocort®
Aqua™ may be attributed to its low spray volume (50 µL
spray per nostril) and because it does not contain benzalkonium
chloride (BKC), a preservative that is known to have a bitter taste;
other corticosteroid sprays, such as fluticasone proprionate contain
this compound.
Figure 1a.
Figure
1b. Percentage of patients responding “yes” when asked if
they perceived specific sensory attributes of Rhinocort® Aqua™
64 µg in 9a) study 1 versus fluticasone proprionate 200 µg
nasal spray and 9b) study 2 versus fluticasone proprionate 100 µg
nasal spray (Shah et al 2003)
Figure 2a.
Figure 2b. Percentages of
patients expressing a global preference for either Rhinocort®
Aqua™ 64 µg in 9a) study 1 versus fluticasone proprionate
200 µg nasal spray and 9b) study 2 versus fluticasone
proprionate 100 µg nasal spray (Shah et al 2003)
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| 2. Is
Rhinocort® effective as a once-daily treatment? |
The
prolonged retention of Rhinocort® in the nasal mucosa and its
rapid systemic metabolism contribute to its clinical efficacy and
tolerability as a once-daily treatment (Brattsand &
Miller-Larsson 2003). Several studies have demonstrated the efficacy
of once-daily Rhinocort® in seasonal (Ciprandi et al 2002) and
perennial (Bende et al 2002) allergic rhinitis, nasal polyps
(Jankowski et al 2001) and allergic rhinoconjunctivitis (Katelaris et
al 2002).
|
| 3. How
does once-daily Rhinocort® improve patient convenience and
adherence? |
Overall,
studies have shown that once-daily dosing can increase patient
adherence (Eisen et al 1990) and is more convenient for asthma
patients using inhaled corticosteroids (Hyland 1999). Indeed two
studies have shown that 65–74% of patients prefer once-daily
dosing with Rhinocort® compared with twice-daily
dosing (Bhatia et al 1991; Ross et al 1991).
|
| 4. What
advantages in formulation does Rhinocort® have over other
intranasal corticosteroids? |
Unlike
most aqueous preparations of intranasal corticosteroids, Rhinocort®
does not contain the preservative benzalkonium chloride (BKC). Several adverse effects have
been linked to BKC including interference with ciliary function and
the mechanism for clearing secretions from the nasal cavity (Hofmann
et al 1998; Steinsvåg et al 1996), increased histamine
sensitivity, more marked nasal swelling (Figure 3a) and higher
evening symptom score for nasal stuffiness (Figure 3b) (Graf et al
1995).
Figure 3a. Mucosal swelling
following 30 days’ treatment with 0.5 mg/mL oxymetazoline nasal
spray with or without benzalkonium chloride in 20 healthy volunteers
(Graf et al 1995)
Figure 3b. Evening nasal stuffiness
following 30 days’ treatment with 0.5 mg/mL oxymetazoline nasal
spray with or without benzalkonium chloride in 20 healthy volunteers
(Graf et al 1995)
When
corticosteroids are used long-term, the presence of BKC in nasal
sprays may accentuate the severity of rhinitis medicamentosa –
a drug-induced, non-allergic form of rhinitis, which is associated
with prolonged use of topical vasoconstrictors (Graf 2004).
As
a consequence of its adverse effects, Beasley and colleagues (2001)
have recommended the withdrawal of BKC from all nebulised solutions.
|
| 5. As
Rhinocort® Aqua™ contains no BKC, is it susceptible to
microbial contamination? |
Rhinocort®
Aqua™ contains the preservative potassium sorbate and
has a shelf life of two years in all markets except the US, which is
18 months. There have been no reports of microbial contamination
occurring during this period in product marketed to date.
|
| 6. References |
Beasley
R, Burgess C, Holt S. Call for worldwide withdrawal of benzalkonium
chloride from nebulizer solutions. J Allergy Clin Immunol
2001; 107: 222–223.
Bende
M, Carrillo T, Vona I, da Castel-Branco MG, Arheden L. A randomized
comparison of the effects of budesonide and mometasone furoate
aqueous nasal sprays on nasal peak flow rate and symptoms in
perennial allergic rhinitis. Ann Allergy Asthma Immunol 2002;
88: 617–623.
Bhatia
M, Campbell LM, Ross JR, Taylor MD, Peers EM, Richardson PD.
Intranasal budesonide once daily in seasonal allergic rhinitis. Curr
Med Res Opin 1991; 12: 287–295.
Brattsand
R, Miller-Larsson A. The role of intracellular esterification in
budesonide once-daily dosing and airway selectivity. Clin Ther
2003; 25: C28–41.
Ciprandi
G, Canonica WG, Grosclaude M, Ostinelli J, Brazzola GG, Bousquet J.
Effects of budesonide and fluticasone propionate in a
placebo-controlled study on symptoms and quality of life in seasonal
allergic rhinitis. Allergy 2002; 57: 586–591.
Eisen
SA, Miller DK, Woodward RS, Spitznagel E, Przybeck TR. The effect of
prescribed daily dose frequency on patient medication compliance.
Arch Intern Med 1990; 150: 1881–1884.
Graf
P, Hallén H, Juto J-E. Benzalkonium chloride in a
decongestant nasal spray aggravates rhinitis medicamentosa in healthy
volunteers. Clin Exp Allergy 1995; 25: 395–400.
Graf
P. Rhinitis medicamentosa: a review of causes and treatment. Treat
Resp Med 2004; in press.
Hofmann
T, Wolf G, Koidl B. Effect of topical corticosteroids and topical
antihistamines on ciliary epithelium of human nasal mucosa in vitro.
HNO 1998; 46: 146–151.
Hyland
ME. Rationale for once-daily therapy in asthma: compliance issues.
Drugs 1999; 58: (Supp) 4: 1–6; discussion 51.
Jankowski
R, Schrewelius C, Bonfils P, Saban Y, Gilain L, Prades JM, Strunski
V. Efficacy and tolerability of budesonide aqueous nasal spray
treatment in patients with nasal polyps. Arch Otolaryngol Head
Neck Surg 2001; 127: 447–452.
Katelaris
CH, Carrozzi FM, Burke TV, Byth K. Effects of intranasal budesonide
on symptoms, quality of life, and performance in elite athletes with
allergic rhinoconjunctivitis. Clin J Sport Med 2002;
12: 296–300.
Ross
JR, Mohan G, Andersson B, Taylor MD, Richardson PD. Budesonide
once-daily in seasonal allergic rhinitis. Curr Med Res Opin
1991; 12: 507–515.
Shah
SR, Miller C, Pethick N, Uryniak T, Jones MK, O'Dowd L. Two
multicenter, randomized, single-blind, single-dose, crossover studies
of specific sensory attributes of budesonide aqueous nasal spray and
fluticasone propionate nasal spray. Clin Ther 2003; 25:
2198–2214.
Steinsvåg
SK, Bjerknes R, Berg OH. Effects of topical nasal steroids on human
respiratory mucosa and human granulocytes in vitro. Acta
Otolaryngol 1996; 116: 868–875.
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