- Email: [email protected]
1147 Efficacy of intranasal budesonide was superior to that of cetirizine during one-year treatment for perennial rhinitis (PR)
J ALLERGY CLIN IMMUNOL
Abstracts
S393
VOLUME 104, NUMBER 1, PART 2
decreased during treatment from a baseline value of 4.6 for BANS and 4.6 for placebo by 1.9 and 0.9 score steps, respectively,
1147
(means for the 2 last weeks; p
Allergy Hospital tEye pital, Helsinki, Finland
in PAR as assessed PNIF measurements.
1146 Azelastine Garay. U400,
by the children
themselves
and by
See. O.R.L.,
HBpital
Bichat,
Paris, France
University
Turbuhaler@) at delivered doses of 280 pg once dose 400 pg) was compared with that of cetirizine (Zyrlex@) 10 kg once daily.
vs. Placebo Nasal Spray in Vasomotor Rhinitis RP P Gehanno, E Deschamps. E Gam.v, M Baehre INSERM
CrBteil,
and Ear Hospital,
Central
Hos-
There is a paucity of long-term studies in perennial rhinitis (PR) with consistent monitoring of efficacy. In this I2-month, randomized, double-blind, single-center, parallel group study, the efficacy of intranasal budesonide (BUD) dry powder (RhinocorK@
well) vs. 42 % for placebo (p
Efficacy of lntranasal Budesonide was Superior to that of Cetirizine during One-year Treatment for Perennial Rhinitis (PR) J Rinne*, M Simola*. H Malmbergt, T Haahtela* *Skin and
daily (metered (CET) tablets
A history of perennial rhinitis for 1-3 years, symptoms for >I hour daily on most days, eosinophils in nasal secretions (cotton swab), and/or a positive skin prick test for perennial allergen were
& ASTA
Medica. Frankfurt, Germany Azelastine is an H l-antagonist used in nasal spray (Allergodil) for the treatment of allergic rhinitis. Azelastine also antagonizes
required. Further, sinus x-rays were taken and anterior rhinoscopy was performed to exclude other disease. After a 2-weeks’ run-in period, 143 patients (89 women) 16-67 years (mean 34.5). were
other inflammatory antiinflammatory humans. Therefore.
randomized. runny nose; (PNEF) were 12th month
mediators and possesses decongestive and properties in several animal models and we investigated if azelastine is also efficient in
treating vasomotor rhinitis. Here we performed a multicenter (19 ENT specialists) randomized double-blind placebo-controlled study of the efficacy and tolerance of azelastine nasal spray in 89 patients (aged 19 to 81 years) with vasomotor rhinitis confirmed by a negative Phadiatop). Following a wash-out period, patients were treated
study start, after 1, 3. 6. 9, 12 months and 12 months + 1 week) acoustic rhinometry measurements were performed to measure nasal cavity volume (NCV). Nasal smear was taken again after I
(diagnosis
and 12 months to detect eosinophil and neutrophil Atopy was found in 108 patients. Efficacy nasal index score (NIS), i.e., the sum of symptom
for I5 days
with 3 puff/nostril/day of azelastine (n=44) or placebo (n=45) nasal spray. Efficacy was evaluated by: (i) the reduction of the prevailing symptomatology (nasal obstruction and rhinorrhea)
significant reduction in the (semiquantitative) smear eosinophils in the BUD treated group CET group (p
Intent to treat analysis revealed better results in the azelastine group for all assessed symptoms: the significance level was reached for nasal obstruction at day I5 (p = 0.042). Using per proloco1 analysis (in 85 patients complying with the protocol), the significance level was reached for nasal obstruction at day 15 (p = 0.017) and for the % of success in rhinorrhea (p = 0.023). In the
tocol analysis). General efficacy assessment by the physician and the patient was in favour of azelastine (with significance levels c 0.01). At day 30 (15 days after the end of the treatment period)
leukocytes. variables were scores (O-15).
PNEF and NCV. Run-in values were comparable. The BUD group showed statistically superior improvement over CET for NIS and NCV at all times (except for NCV at I month, p=O.O52). Also, there was a
assessed on a visual analogue scale (VAS, score from 0 to 100 mm), (ii) rhinoscopy and (iii) general efficacy assessment by the physician and the patient.
azelastine group, rhinoscopy examination showed significantly higher reduction in the inflammatory level and edema of the nasal mucosa (p = 0.03 and 0.02 for VAS at day 15 respectively, per pro-
Nasal symptom scores (blocked nose, sneezing, and O-5 score for each) and peak nasal expiratory flow recorded daily during run-in, during the lst, 6th. and and during a l-week follow-up. At the clinic visits (
CHANGE IN NIS BUD (5.471
MONTHS I 6 I? I?+ I WEEK
-I 97 -2 49 -2.48 -I.66
CET 15.741
CHANGE IN PNEF k/MINI BUD vs. CET
BUD 1236)
GET IWlI
number of nasal compared with the at 12 months). CHANGE IN NCV (ML1
BUD vs. CET
BUD BUD ll3.91
-1.08
l **
19
5
**
0.5
-15, ., .$(j
*** .. .
22 21
10 10
* NS
0.8 0.3
-0.2 -0.4 -1.0
NSIW *** ***
-0.09
-*’
29
8
l
-0.2
-0.8
NS
nasal obstruction and rhinorrhea remained significantly lower in patients previously included in the azelastine group. No drowsiness or serious adverse event was reported and the frequency of
CET
mouth dryness and cephaleas groups. In conclusion, the present
tion over time. The BUD group, remaining at a lower symptom intensity, had persisting benefit of anti-inflammatory treatment. In conclusion, budesonide 280 pg once daily had superior effi-
was similar study
in the two
demonstrated
treatment
the efficacy
of
azelastine nasal spray in the treatment of vasomotor rhinitis. The best achieved results were a decrease in nasal obstruction and mucosal edema. This therapeutic benefit of azelastine nasal Sprdy in vasomotor rhinitis can be due to its anti-inflammatory and decongestive
properties.
Return to run-in symptom levels, I week after cessation of treatment, confirms consistency of symptoms in the popula-
cacy to that of cetirizine 10 mg and efficacy was maintained I2 months. Sponsored by AstraZeneca R&D, Lund, Sweden.
for
Abstracts
S393
VOLUME 104, NUMBER 1, PART 2
decreased during treatment from a baseline value of 4.6 for BANS and 4.6 for placebo by 1.9 and 0.9 score steps, respectively,
1147
(means for the 2 last weeks; p
Allergy Hospital tEye pital, Helsinki, Finland
in PAR as assessed PNIF measurements.
1146 Azelastine Garay. U400,
by the children
themselves
and by
See. O.R.L.,
HBpital
Bichat,
Paris, France
University
Turbuhaler@) at delivered doses of 280 pg once dose 400 pg) was compared with that of cetirizine (Zyrlex@) 10 kg once daily.
vs. Placebo Nasal Spray in Vasomotor Rhinitis RP P Gehanno, E Deschamps. E Gam.v, M Baehre INSERM
CrBteil,
and Ear Hospital,
Central
Hos-
There is a paucity of long-term studies in perennial rhinitis (PR) with consistent monitoring of efficacy. In this I2-month, randomized, double-blind, single-center, parallel group study, the efficacy of intranasal budesonide (BUD) dry powder (RhinocorK@
well) vs. 42 % for placebo (p
Efficacy of lntranasal Budesonide was Superior to that of Cetirizine during One-year Treatment for Perennial Rhinitis (PR) J Rinne*, M Simola*. H Malmbergt, T Haahtela* *Skin and
daily (metered (CET) tablets
A history of perennial rhinitis for 1-3 years, symptoms for >I hour daily on most days, eosinophils in nasal secretions (cotton swab), and/or a positive skin prick test for perennial allergen were
& ASTA
Medica. Frankfurt, Germany Azelastine is an H l-antagonist used in nasal spray (Allergodil) for the treatment of allergic rhinitis. Azelastine also antagonizes
required. Further, sinus x-rays were taken and anterior rhinoscopy was performed to exclude other disease. After a 2-weeks’ run-in period, 143 patients (89 women) 16-67 years (mean 34.5). were
other inflammatory antiinflammatory humans. Therefore.
randomized. runny nose; (PNEF) were 12th month
mediators and possesses decongestive and properties in several animal models and we investigated if azelastine is also efficient in
treating vasomotor rhinitis. Here we performed a multicenter (19 ENT specialists) randomized double-blind placebo-controlled study of the efficacy and tolerance of azelastine nasal spray in 89 patients (aged 19 to 81 years) with vasomotor rhinitis confirmed by a negative Phadiatop). Following a wash-out period, patients were treated
study start, after 1, 3. 6. 9, 12 months and 12 months + 1 week) acoustic rhinometry measurements were performed to measure nasal cavity volume (NCV). Nasal smear was taken again after I
(diagnosis
and 12 months to detect eosinophil and neutrophil Atopy was found in 108 patients. Efficacy nasal index score (NIS), i.e., the sum of symptom
for I5 days
with 3 puff/nostril/day of azelastine (n=44) or placebo (n=45) nasal spray. Efficacy was evaluated by: (i) the reduction of the prevailing symptomatology (nasal obstruction and rhinorrhea)
significant reduction in the (semiquantitative) smear eosinophils in the BUD treated group CET group (p
Intent to treat analysis revealed better results in the azelastine group for all assessed symptoms: the significance level was reached for nasal obstruction at day I5 (p = 0.042). Using per proloco1 analysis (in 85 patients complying with the protocol), the significance level was reached for nasal obstruction at day 15 (p = 0.017) and for the % of success in rhinorrhea (p = 0.023). In the
tocol analysis). General efficacy assessment by the physician and the patient was in favour of azelastine (with significance levels c 0.01). At day 30 (15 days after the end of the treatment period)
leukocytes. variables were scores (O-15).
PNEF and NCV. Run-in values were comparable. The BUD group showed statistically superior improvement over CET for NIS and NCV at all times (except for NCV at I month, p=O.O52). Also, there was a
assessed on a visual analogue scale (VAS, score from 0 to 100 mm), (ii) rhinoscopy and (iii) general efficacy assessment by the physician and the patient.
azelastine group, rhinoscopy examination showed significantly higher reduction in the inflammatory level and edema of the nasal mucosa (p = 0.03 and 0.02 for VAS at day 15 respectively, per pro-
Nasal symptom scores (blocked nose, sneezing, and O-5 score for each) and peak nasal expiratory flow recorded daily during run-in, during the lst, 6th. and and during a l-week follow-up. At the clinic visits (
CHANGE IN NIS BUD (5.471
MONTHS I 6 I? I?+ I WEEK
-I 97 -2 49 -2.48 -I.66
CET 15.741
CHANGE IN PNEF k/MINI BUD vs. CET
BUD 1236)
GET IWlI
number of nasal compared with the at 12 months). CHANGE IN NCV (ML1
BUD vs. CET
BUD BUD ll3.91
-1.08
l **
19
5
**
0.5
-15, ., .$(j
*** .. .
22 21
10 10
* NS
0.8 0.3
-0.2 -0.4 -1.0
NSIW *** ***
-0.09
-*’
29
8
l
-0.2
-0.8
NS
nasal obstruction and rhinorrhea remained significantly lower in patients previously included in the azelastine group. No drowsiness or serious adverse event was reported and the frequency of
CET
mouth dryness and cephaleas groups. In conclusion, the present
tion over time. The BUD group, remaining at a lower symptom intensity, had persisting benefit of anti-inflammatory treatment. In conclusion, budesonide 280 pg once daily had superior effi-
was similar study
in the two
demonstrated
treatment
the efficacy
of
azelastine nasal spray in the treatment of vasomotor rhinitis. The best achieved results were a decrease in nasal obstruction and mucosal edema. This therapeutic benefit of azelastine nasal Sprdy in vasomotor rhinitis can be due to its anti-inflammatory and decongestive
properties.
Return to run-in symptom levels, I week after cessation of treatment, confirms consistency of symptoms in the popula-
cacy to that of cetirizine 10 mg and efficacy was maintained I2 months. Sponsored by AstraZeneca R&D, Lund, Sweden.
for