Edit Tailoring The Optimal Management of AR2

TAILORING
THE OPTIMAL MANAGEMENT

OF ALLERGIC RHINITIS
dr. Dwi Reno P.,Sp.THT-KL (K)

Dep/SMF IK THT-KL
FKUA RSUD Dr. Soetomo
ALLERGIC RHINITIS:
CLASSIFICATION
AND MANAGEMENT
GUIDELINE
Diagnostic Of Allergic Rhinitis
Symptoms usually NOT
Symptoms suggestive
associated
of allergic rhinitis
with allergic rhinitis
Unilateral symptoms ++++

2 or more of the following
Nasal obstruction without other
symptoms
symptoms
for >1 h on most days
Mucopurulent rhinorrhea
Watery rhinorrhea
Posterior rhinorrhea
Sneezing, especially
(post nasal drip)
paroxysmal
With thick mucus
Nasal obstruction And/or no anterior rhinorrhea
Nasal pruritis Pain
Conjunctivitis Recurrent epistaxis
Anosmia
Refer the patient to

Classify and assess severity
a doctor (specialist)
Bousquet J, Allergy 2008: 63 (Suppl. 86): 8160
ARIA Classification of Allergic Rhinitis
INTERMITTENT PERSISTENT
<4 days per week or >4 days per week and
<4 weeks >4 weeks
MILD MODERATESEVERE
Normal sleep and One or more items
No impairment of daily Abnormal sleep
activities, sport, leisure and Impairment of daily activities,
Normal work and school and sport, leisure
No troublesome symptoms Impaired work and school
Troublesome symptoms
In untreated patients
ARIA, Allergic Rhinitis and its Impact on Asthma
Bousquet J et al. J Allergy Clin Immunol 2001;108(Suppl 5):S147336; ARIA: at a glance pocket reference 2007.
PRIMARY TREATMENT GOAL
FOR PATIENTS WITH ALLERGIC RHINITIS
To alleviate symptom severity

To reduce the risk of developing
associated disorders
Bousquet J, Allergy 2008: 63 (Suppl. 86): 8160

Allergen Avoidance
Environmental control measures and allergen

avoidance involve both the avoidance of known
allergens (substances to which the patient has
IgE-mediated hypersensitivity) and avoidance of
nonspecific, or irritant, triggers.
Consider environmental control measures,
when practical, in all cases of allergic rhinitis.
Sheikh MD, et al. Allergic Rhinitis Treatment & Management. Available at:
http://emedicine.medscape.com/article/134825-treatment Accessed on: February 21, 2012
ARIA: Stepwise Approach for
Treatment of Allergic Rhinitis
Bousquet J, ARIA Guideline.Allergy 2008: 63 (Suppl. 86): 8160.Saleh H A , Durham S R BMJ 2007;335:502-507
Anti histamine can be
use start from mild
intermittent Allergic
Rhinitis
ARIA
2008
Role of Anti Histamine
Focus on Levocetirizine
Should oral H1-antihistamines be used for the
treatment of AR?
Recommendation:
In patients with AR, we recommend new-generation oral H1-
antihistamines that do not cause sedation and do not
interact with cytochrome P450 (strong
recommendation/low-quality evidence).
Brozek J et al. ARIA J Allergy Clin Immunol 2010;126:466-76.

LEVOCETIRIZINE
Levocetirizine
Is the L-enantiomer of the racemate, cetirizine
dihydrochloride
2x affinity for H1-receptors compared to cetirizine
Highly specific for the H1-receptor
Undergoes minimal metabolism
Is not a substrate for cytochrome P450
No drug interaction
Levocetirizine
volume of distribution
Does not impair daily activities
Does not affect QTc interval
Can be used concomitantly with other drugs

without risk of interactions
No inter-subject variability
SAR study
Comparative clinical efficacy, onset and duration

of action of levocetirizine and desloratadine for
symptoms of seasonal allergic rhinitis in subjects
evaluated in the Environmental Exposure Unit
(EEU)
Day JH, Briscoe MP, Rafeiro E, Ratz JD

Int J Clin Pract 2004; 58: 109-18
Day 2004 Levocetirizine and desloratadine in
EEU TM
Objective
To compare clinical efficacy, onset and duration of
action of levocetirizine and desloratadine
Day et al. J Clin Pract 2004; 58: 109-18

EEU TM
The EEU controls confounding variables through:

Standardized pollen type, standardized concentrations
Removal of wild allergens by filtration
Standardized scoring of symptom severity * levels and of medical efficacy
EEU TM
Study design
Day 1 Day 2
Baseline Period I Period II Period III
(8:00 AM to (10:00 AM to (8:30 AM to (10:00AM to
10:00 AM) 3:00 PM) 10:00 AM) 2:30PM)
EEU
8:00AM 10:00AM 3:00PM 8:30AM 10:00AM 2:30PM
- 2.0 -1.5 -1.0 -0.5 0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 22.5 23 23.5 24 24.5 25 25.5 26 26.5 27 27.5 28 28.5
Randomisation, Second Dose *

First Dose *
* Levocetirizine 5 mg (n=141), desloratadine 5 mg (n=140) or placebo (n=92)
Adapted from Day et al. J Clin Pract 2004; 58: 109-18

EEU TM
Evolution of Major Symptom Complex (MSC) score

Levocetirizine 5 mg Placebo Desloratadine 5 mg
10.0
Reduction from baseline MSC Score
* * * *
9.0 * * * *
* * *
8.0 * * * * *
* * * *
7.0 *
*
6.0 * * *
5.0
(LS Mean)
*
4.0 * *
3.0
*
2.0 *
1.0
0.0
-1.0
-2.0
Drug intake Drug intake
-3.0
0 1 2 3 4 5 23 24 25 26 27 28
Hours after first drug intake
Period I Period II Period III (n=373)
* p < 0.001 vs placebo p < 0.05 vs placebo

p < 0.05 vs desloratadine
EEU TM
MSC change from baseline

***
9 *** ***
*
8
** *** *** * ***
Levocetirizine
7
Placebo
6 Desloratadine
3
* p < 0.015
2 ** p < 0.005
*** p < 0.001
1
0 (n=373)
Period I Period II Period III
EEU TM
Improvement of nasal congestion in period 1
Placebo 1
p < 0.001
NS (p = 0.078)
Desloratadine 5 mg 1.72
p = 0.007
Levocetirizine 5 mg 2.72
1 2 3
Magnitude of symptom relief from baseline (placebo = 1)
(n=373)

EEUTM
Onset of action
e
Levocetirizine 5 mg
1h
om
r baselin
)
Desloratadine d III
ir5 mg
o 3h
e
P
ean ( change f
M

es
ro
c
MSC s (n=373)

EEUTM
Symptom relief at 24 hours

Desloratadine Levocetirizine
Placebo 5 mg
* 5 mg
0
MSC mean change from baseline
(Period II)
-3.37
-4.74
p=0.015
p<0.001 (n=373)

EEU TM
Conclusions
Levocetirizine has a faster onset of action than
desloratadine (1 vs. 3 hours)
The efficacy of levocetirizine on rhinitis
symptoms (including nasal obstruction) is
greater and more sustained than
desloratadine
Day et al. J Clin Pract 2004; 58: 109-18

PAR study
Levocetirizine is effective for symptom

relief including nasal congestion in
adolescent and adult (PAR) sensitized to
house dust mites
Potter PC, on behalf of the Study Group

Allergy 2003; 58: 893-9
Potter 2003 Levocetirizine in Perennial Allergic
Rhinitis
Mean Total 4-Symptoms Score (T4SS)
+86% +56% +47%
4 p<0.001 p<0.001 p<0.001
Score Improvement from baseline
3,5
3,64
3,4
3
2,5 2,63 2,74
2 2,18
1,5
1,41
1
0,5
0
Over 1 week Over 4 weeks Over 6 weeks
Placebo (n=142) Levocetirizine (n=150)
T4SS = nasal pruritus, ocular pruritus, rhinorrhoea and sneezing
Adapted from Potter PC Allergy 2003; 58: 893-9
Rhinitis
Individual symptom scores after 1 week
160 p = 0.002
Levocetirizine 5 mg (n=150)
relative improvement over placebo [%]
154%
140
p < 0.001
120
120%
100 p < 0.001
p < 0.001
94%
80
82%
60 p = 0.008
55%
40
20
0
Ocular Nasal Rhinorrhoea Sneezing Nasal
pruritus pruritus congestion

Rhinitis
Nasal congestion over 6 weeks
0,6 **
** 0.59
* 0.55
score improvement
Nasal congestion
RELIEF + 83%
0,4 0.43
0.32
0.27
0,2
0.17
0
0 1 4 6 Weeks
Levocetirizine 5 mg (n=150) Placebo (n=142) * p=0.002 ** p<0.001

Rhinitis
Improvement of nasal congestion from baseline (n=294)
p< 0.001
p<0.001 + 83%
0,7 p=0.002
+ 103% Levocetirizine 5mg (n=150)
+ 154%
0,6 Placebo (n=142)
score improvement
Nasal congestion
0,5
0,4
0,3
0,2
0,1
0
Over 1 week Over 4 weeks Over 6 weeks

Rhinitis
Conclusions
Levocetirizine 5 mg daily is an effective and
well-tolerated treatment of Perennial Allergic
Rhinitis
Levocetirizine is effective for the relief of nasal
congestion
Potter PC Allergy 2003; 58: 893-9

PAR study
Levocetirizine improves quality of life

and reduces costs in long-term
management
of persistent allergic rhinitis
Bachert C, Bousquet J, Canonica W, Durham S, Klimek L, Mullol J,

Van Cauwenberge P, Van Hamme G and the XPERTTM Study Group
J Allergy Clin Immunol 2004; 114: 838-44
Bachert 2004 Levocetirizine in Persistent
Allergic Rhinitis Trial (XPERT ) TM
Objective
To assess the safety and efficacy on symptoms

and quality of life of levocetirizine for the long-
term treatment of persistent allergic rhinitis as
defined by ARIA (Allergic Rhinitis and its
Impact on Asthma)
Bachert C et al. J Allergy Clin Immunol 2004; 114: 838-44

Treatment
Selection Post
6 months treatment
Levocetirizine 5mg
or Placebo
V1 V2 V3 V4 V5 V6 V7 V8
Wk 1 W0 W1 W4 M3 M 41/2 M6 M 6 +1W
Overall trial duration of 6 months and 2 weeks (8 visits)
Adapted from Bachert C et al. J Allergy Clin Immunol 2004; 114: 838-44

Improvement of RQLQ domains

Data at week 4 - similar improvement maintained over 6 months
2,2
* *
RQLQ score improvement from baseline
*
) 2) * *
2
* *
1,1
ea
r (mm
heal a
W
mean wheal (mm
0
Placebo (n=273) Levocetirizine (n=278) * p < 0.001

Adapted from Bachert C et al. J Allergy Clin Immunol 2004; 114: 838-44
Mean direct and indirect costs

Conclusions
Levocetirizine improves quality of life and

symptoms in patients with PER over 6 months
Levocetirizine decreases the overall costs of
the disease over 6 months

Levocetirizine appears to be a rapidly and
sustainably effective antihistamine for the
treatment of PER and provides statistically
significant and clinically meaningful
improvements of symptom scores, overall HRQoL
and pharmacoeconomic criteria, which are some
of the key criteria for the successful treatment of
a chronic disease.
Clinical Efficacy of Levocetirizine
in Pediatrics
SAR study
Levocetirizine in children:
evidenced efficacy and safety in a 6-
week randomized seasonal allergic
rhinitis trial
de Blic J, Wahn U, Billard E, Alt R, Pujazon MC

Pediatr Allergy Immunol 2005: 16: 267275.
de Blic 2005 Efficacy of levocetirizine in
children
Study design
1 week 2 weeks 2 weeks 2 weeks
Levocetirizine 5 mg (n=89) or placebo (n=88)
Start Start Control Control End

screening treatment visit visit visit
Adapated from de Blic J et al. Pediatr Allergy Immunol 2005: 16: 267275.
children
Improvement in T4SS
P<0.001
4 P<0.001
52.0%
T4SS improvement in median %
46.4%
P<0.001
change from baseline (n=177)
3 P<0.001
38.8%
32.9% 31.0%
25.0%
2
15.3%
11.5%
1
0
Over the first Over the first Over the first Over the whole
week 2 weeks 4 weeks 6 weeks
Placebo Levocetirizine 5mg

de Blic J et al. Pediatr Allergy Immunol 2005: 16: 267275.
children
Sneezing
P<0.001
1 P<0.001
52.5%
51.0%
median % change from baseline (n=177)
P<0.001
0.8
39.3%
Improvement symptom scores: in
0.6
27.1%
23.0%
0.4
13.9%
0.2
0
1 st 2 weeks 1 st 4 weeks All 6 weeks
children
Rhinorrhea
1 P<0.002
P<0.002 51.3%
44.4%
0.8 P<0.001
36.3%
0.6
27.8%
22.8%
0.4
6.1%
0.2
0
Adapted from de Blic J et al. Pediatr Allergy Immunol 2005: 16: 267275.
children
Nasal pruritus
1 P<0.004
P<0.001 56.4%
0.8 48.5%
P<0.002
28.9%
37.5%
0.6 23.5%
13.5%
0.4
0.2
0
children
Improvement in PRQLQ scores week 2
1.2
40.6%
30.9%
36.1%
33.7%
0.8
33.5%
PRQLQ score Improvement in
23.2%
15.7% 28.5%
18.2%
22.5% 19.2%
19.4%
0.4
0
Nose Eye Practical Other Activity Overall
symptoms symptoms problems symptoms limitations scores
Conclusions
The study demonstrates that levocetirizine has an
excellent safety profile and efficacious in reducing
the symptoms of SAR (including nasal congestion) in
children aged 6 to 12 years
The study also confirms the need for continuous
treatment (throughout the pollen season) of SAR in
children with a potent antihistamine to ensure good
overall symptoms control and increased quality of
life
Levocetirizine can be safely used in children on a
daily basis during the full duration of the pollen
season
PAR study
Potter P.C. Ann Allergy Asthma Immunol 2005: 95: 175-180
Efficacy and safety of levocetirizine on

symptoms and health-related
quality of life of children with
perennial allergic rhinitis: a double-blind
placebo controlled randomized clinical trial.
Potter 2005 Levocetirizine in children with PAR
Decrease of at least 50 % in the T4SS (50 % responder rate)
20
17,5
* p = 0.011 ** p = 0.117
**
15
50% T4SS decrease (n=306)
% of patients showing
12,3
11,2
*
10
5 3,9
0
Over 2 weeks Over 4 weeks
Placebo (n=152) Levocetirizine 5mg (n=154)
T4SS evolution
2
* p = 0.001 ** p = 0.008 1,94
**
score improvement from baseline
1,47
1,5
1,32
*
Mean T4SS evolution
1
0,75
0,5
(n=306)
0
Over 2 weeks Over 4 weeks
PRQLQ overall score improvement
ns
1
Score improvement from baseline
0,8 p = 0.014
p = 0.015
0,6
0,4
(n=306)
0,2
0
1 week 2 weeks 4 weeks
Conclusions
Levocetirizine provides a significant relief during the
whole duration of the trial
The biggest difference between levocetirizine and
placebo was noticed at 2 weeks
The difference between the two study groups was
significant in favour of levocetirizine even in the last 2
weeks of the study when the T4SS in the placebo group
was markedly increased
The study confirms the efficacy and safety of
levocetirizine in relieving symptoms of perennial allergic
rhinitis in children aged 6 12 years with a positive
impact on HRQL
Comments
During the last two weeks of the study, the placebo

effect markedly increased, the difference with
levocetirizine remained significant though. The
explanation of the increased placebo effect could lie in
the more frequent use of concomitant medications in
the placebo group, as no rescue medication was
provided

Intranasal corticosteroids
are gold standard first-line
therapy for moderate-to-
severe persistent allergic
rhinitis
ARIA
2008
Should intranasal glucocorticosteroids be used
for treatment of AR?.
Recommendation:
We recommend intranasal glucocorticosteroids for
treatment of AR in adults (strong recommendation / high-
quality evidence) and suggest intranasal glucocorticosteroids
in children with AR (conditional recommendation /
moderate-quality evidence).
Brozek J et al. ARIA J Allergy Clin Immunol 2010;126:466-76.
FLUTICASONE FUROATE
Fluticasone Furoate
INNOVATION ON THE CHEMICAL
STUCTURE
Fluticasone Furoate:
glucocorticoid with enhanced affinity
Fluticasone furoate: a combination of the fluticasone backbone
and a 17- furoate ester
O S C H 2F
Fluticasone backbone O Furoate ester group
O CO
HO
17
F Enhanced glucocorticoid
O affinity and greater selectivity
F
FF is a distinct drug molecule and not a salt

or a pro-drug of fluticasone
Biggadike K et al. Ann Allergy Asthma Immunol 2007;98(Suppl 1):A91A92. Salter M et al. Am J Physiol Lung Cell Mol Physiol 2007;293:L660L667.
Fluticasone Furoate:
an enhanced-affinity glucocorticoid
Affinity of INS for the human lung glucocorticoid receptor
Relative receptor affinity (RRA)
3000
2500
2000
1500
1000
500
0
Fluticasone Mometasone Fluticasone Beclometha- Ciclesonide Budesonide Dexamethasone
furoate propionate sone-17- active
furoate monopropionate principle
Valotis A, Hgger P. EAACI. 2006, Abstract 780.

Fluticasone Furoate: protection against
mechanically induced inflammatory damage
120 FF
110 FP
100 MF
Wound area (% of control)
90 Budesonide
80
70
60
50
40
30
20
0.001 0.01 0.1 1 10
Glucocorticoid concentration (nM)
Salter M et al. Am J Physiol Lung Cell Mol Physiol 2007;293:L660L667.

Fluticasone Furoate tissue retention in
human lung epithelial cells
High retention of Fluticasone furoate in tissues enhances its duration of action
4h 30 h
Fluticasone propionate
(10-10M)
Fluticasone furoate
(10-10M)
FF remains bound to glucocorticoid receptor

at its cellular site of action for >24 hours
Adcock I, Ito K, data on file; Valotis A, Hgger P. Respir Res 2007;8:54.

Fluticasone Furoate is highly selective for GR relative to the
mineralocorticoid receptor and progesterone receptor-b
Human steroid hormone receptor selectivity
0 10 20 30 40 50 500 600 700 800 900
Fluticasone
furoate
Fluticasone
propionate
Mometasone
furoate Mineralocorticoid receptor
Ciclesonide active Progesterone receptor-b

principle
Budesonide
800/1
1/1 Selectivity for the GR
High selectivity
Low selectivity
Selectivity of all compounds for androgen receptor >1700 and for oestrogen receptor >22,000
Salter M et al. Am J Physiol Lung Cell Mol Physiol 2007;293:L660L667.

Fluticasone Furoate: Low bioavailability
25
Bioavailability of currently used INS 20%
20
% bioavailability
15
11%
10
5
0.5% 0.5% 0.5%
0
Fluticasone Fluticasone Mometasone Budesonide Flunisolide
furoate propionate furoate
Bryson HM, Faulds D. Drugs 1992;43:76075.

Daley-Yates PT, Baker RC. Br J Clin Pharmacol 2001;51:1035.
Daley-Yates PT et al. Eur J Clin Pharmacol 2004;60:2658.
Allen A et al. Clin Ther 2007;29:141520.
Summary:
Fluticasone Furoate has a unique pharmacological
profile (enhanced affinity and high selectivity) with
improvements in efficacy, duration of action and safety.
These properties can be attributed to the optimal
structural combination of furoate ester and fluticasone
steroid backbone.
Fluticasone furoate is an improved anti-inflammatory

glucocorticoid compared with fluticasone propionate
and mometasone furoate
Fluticasone Furoate
INNOVATION ON THE ADVANCED
DEVICE
Patient-perceived unmet needs with current
nasal spray devices
Less than 50% of patients think that currently available devices
for intranasal steroids are easy to use
Reported weaknesses include:
Drip down the Taste and Difficulty Difficult to Uncomfortable

throat or out smell triggering and administer to delivery nozzle
through the nose handling third parties
Berger WE et al. Expert Opin Drug Deliv 2007;4:689701.

Fluticasone Furoate device:
comparison to traditional devices

Delivery system is designed
to meet the needs of patients
Easy to use device
Patient-friendly spray
No taste or smell
Little or no drip down
the throat (half the Nozzle is short and
spray volume of other ergonomically designed
intranasal steroids Comfortable for
Gentle spray, a patients
consistent amount
each time
Easy to grip with side
actuation
Viewing window
See how much is left

Fluticasone Furoate
CONTINUOUS CLINICAL TRIALS
China (IAR/PAR, 113342)
IAR, PAR Phase III Asian Adults &

adolescent study
IAR: intermittent allergic rhinitis

PAR: perennial allergic rhinitis Han D et al., Allergy Asthma Proc. 2011;32(6):472-81.
Nasal efficacy (rTNSS):
mean change from baseline was greater
for FNSS compared with placebo
Subgroup analysis for IAR and PAR indicated that the mean change from baseline over
the entire treatment period (2 weeks) was also greater for FFNS.
Han D et al., Allergy Asthma Proc. 2011;32(6):472-81.
Nasal efficacy (individual nasal symptoms) : FFNS was
more effective than placebo
Nasal Nasal
Rhinorrea Congestion Itching Sneezing
0
versus placebo over treatment period
-0.2
-0.4
LS mean change FFNS 110 g
FFNS 100mcg
-0.6
Placebo
* p<0.0001
-0.8
-1 *
* *
-1.2 *
Han D et al., Allergy Asthma Proc. 2011;32(6):472-81.

Presented at XXIX Congress of the European
Academy of Allergy and Clinical Immunology
London, June 5-9, 2010
Objectives:
The objective of this study was to evaluate the differences
in symptom control (symptom free days), quality of life and
resource use for SAR patients receiving FF, MF and FP
Indication: Allergic Rhinitis (AR)
Study Design: Cross-sectional, non-interventional, cohort
analysis.
Study Population: 90 Primary Care Physicians and 45
allergists in France, Germany, and Spain. A total of 540
patients where recruited during July 2009.
Conclusion:
FF was associated with more symptom

free days than FP (p=0.046)
and a better quality of life than MF
(p=0.026)
Tolerability profile
Ocular tolerability profile
From: Miller et al. AAAAI 2012 P944
In 2-year randomized trial (n=548) to assess ocular
safety in PAR subjects receiving FFNS compared with
placebo,
No statistically significant different in time to
event for LOCS III posterior subcapsular opacity
(14 FFNS (4%) and 4 placebo subjects (2%) had an
event, p=0.395)
95% of subjects in both groups had intraocular
pressure within 5mmHg of baseline
No cataracts and glaucoma were reported
LOCS: lens opacities classification system
Key Messages:
Fluticasone furoate:
An enhanced-affinity glucocorticoid efficacy
Highly selective for the glucocorticoid receptor
safety
Proven clinical studies for both Seasonal and
Perennial Allergic Rhinitis Symptoms
24-hour duration of action
Unique side-actuated device
THANK YOU

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TAILORING

THE OPTIMAL MANAGEMENT

dr. Dwi Reno P.,Sp.THT-KL (K)

Unilateral symptoms ++++

Refer the patient to

To alleviate symptom severity

Bousquet J, Allergy 2008: 63 (Suppl. 86): 8160

Environmental control measures and allergen

Brozek J et al. ARIA J Allergy Clin Immunol 2010;126:466-76.

2x affinity for H1-receptors compared to cetirizine

Highly specific for the H1-receptor

Undergoes minimal metabolism

Is not a substrate for cytochrome P450

Does not impair daily activities

Does not affect QTc interval

Can be used concomitantly with other drugs

Comparative clinical efficacy, onset and duration

Day JH, Briscoe MP, Rafeiro E, Ratz JD

Day et al. J Clin Pract 2004; 58: 109-18

The EEU controls confounding variables through:

Randomisation, Second Dose *

* Levocetirizine 5 mg (n=141), desloratadine 5 mg (n=140) or placebo (n=92)

Adapted from Day et al. J Clin Pract 2004; 58: 109-18

Evolution of Major Symptom Complex (MSC) score

Period I Period II Period III (n=373)

* p < 0.001 vs placebo p < 0.05 vs placebo

MSC change from baseline

Improvement of nasal congestion in period 1

Magnitude of symptom relief from baseline (placebo = 1)

Adapted from Day et al. J Clin Pract 2004; 58: 109-18

Adapted from Day et al. J Clin Pract 2004; 58: 109-18

Symptom relief at 24 hours

Adapted from Day et al. J Clin Pract 2004; 58: 109-18

Day et al. J Clin Pract 2004; 58: 109-18

Levocetirizine is effective for symptom

Potter PC, on behalf of the Study Group

2,5 2,63 2,74

Adapted from Potter PC Allergy 2003; 58: 893-9

Adapted from Potter PC Allergy 2003; 58: 893-9

Adapted from Potter PC Allergy 2003; 58: 893-9

Potter PC Allergy 2003; 58: 893-9

Levocetirizine improves quality of life

Bachert C, Bousquet J, Canonica W, Durham S, Klimek L, Mullol J,

To assess the safety and efficacy on symptoms

Bachert C et al. J Allergy Clin Immunol 2004; 114: 838-44

Overall trial duration of 6 months and 2 weeks (8 visits)

Bachert C et al. J Allergy Clin Immunol 2004; 114: 838-44

Improvement of RQLQ domains

Placebo (n=273) Levocetirizine (n=278) * p < 0.001

Mean direct and indirect costs

Bachert C et al. J Allergy Clin Immunol 2004; 114: 838-44

Levocetirizine improves quality of life and

Bachert C et al. J Allergy Clin Immunol 2004; 114: 838-44

de Blic J, Wahn U, Billard E, Alt R, Pujazon MC

1 week 2 weeks 2 weeks 2 weeks

Levocetirizine 5 mg (n=89) or placebo (n=88)

Start Start Control Control End

Placebo Levocetirizine 5mg

Potter P.C. Ann Allergy Asthma Immunol 2005: 95: 175-180

Efficacy and safety of levocetirizine on

During the last two weeks of the study, the placebo

Potter P.C. Ann Allergy Asthma Immunol 2005: 95: 175-180

FF is a distinct drug molecule and not a salt