100525_Poster EACCIt

Ectoin-containing nasal spray is as effective as
cromoglycinate nasal spray in improving the symptoms
of allergic rhinitis
Bilstein, A.2 Sonnemann, U.1
1 Elmshorn, Germany , 2 bitop AG, Witten, Germany
Background
Conclusion
Ectoin containing topical formulations are a new option for the
treatment of allergic symptoms. Ectoin is a cyclic amino acid,
identified as a compatible solute in moderately halophilic
bacteria conferring resistance towards stressors like temperature
or salt. Ectoin is used for symptomatic treatment of rhinitis sicca,
protection
against
skin
dryness
and
abatement
of
neurodermatitis. The mode of action involves physical
stabilization of biological macromolecules and structures like
proteins, membranes and whole cells. Consequently, it was of
interest to investigate whether its usage as Ectoin Allergy Nasal
Spray might be as beneficial in the treatment and prophylaxis of
allergic rhinitis as standard therapy with cromoglycinate nasal
spray.
Both nasal sprays studied showed significant improvement of all
nasal symptoms, with marked difference between visit 1 (prior
treatments) and visits 2 and 3 (with treatment), but not between
treatments. However patients rated Ectoin Allergy Nasal Spray as
significantly better tolerated compared to cromoglycinate nasal
spray. These results were independent of the changes in air pollen
charge.
Method
Effect on Nasal Congestion
Main objective of the present study was to prove that Ectoin
Allergy Nasal Spray reduces symptoms of acute allergic rhinitis in a
two-week observational, randomized comparative cross-over
study with 50 patients suffering from acute allergic rhinitis.
Patients used either Ectoin-containing nasal spray (five times a
day) or cromoglycinate nasal spray (4 times a day). After one week
of treatment, a cross-over between the groups was performed
with a subsequent one week’s treatment. Levels of allergic
symptoms were recorded using a combined nasal and non-nasal
symptom score rating scale by physician on 3 visits (at day 1 before
the application of the medication, at day 7 before the cross-over
and after 14 day) and patients (day 3,6,9 and 12) (rating the
symptoms being 0 excellent and 8 very bad)
Combined Nasal Symptom Score
The sum of the three different parameters nasal congestion,
rhinorhea and nasal errhine were investigated as combined score.
They showed the most marked reduction after the first week. No
significant differences between visit 2 and visit 3 were found,
indicating that the main effect of therapy is attained during the
first week. A similar result was obtained after the score was
evaluated by the patients themselves.
Score
visit 1
group 1 (Ectoin Cromoglycinate)
16.64
Score
visit 2
8.16
Ectoin Allergy Nasal Spray, together with Ectoin Allergy Eye Drops
opens up a new promising way to treat allergic symptoms in a
soft and effective way.
Nasal Congestion Score
8
7
6
5
4
3
2
1
0
**
visit 1
Improvement in % to previous visit
group 2 (Cromoglycinate Ectoin) 16.28
51%
9.92
24%
8.28
Improvement in % to previous visit
39%
17%
p<0.001
p<0.001
Compliance and tolerance
Compliance of all patients was very good (score 1). In contrast,
only the treatment corresponding to Ectoin Allergy Nasal Spray
was considered as “very good”, with a 0.88 - 1.24 score,
significantly (p<0.001) better than cromoglycinate therapy, which
was noted only as “satisfactory” (score 2.4 - 3). Patients produced
with their diary cards similar being Ectoin Allergy Nasal Spray
(score 1.13) significantly better evaluated than cromoglycinate
spray (score 2.5, p< 0.001).
group 2
**
3,2 3,44
2,52
visit 2
2,92
visit 3
Group 1 received first Ectoin Allergy Nasal Spray, group 2 received first
cromoglycinate nasal spray. After one week (visit 2) of treatment both
groups showed significant decreases in their nasal congestion
compared to visit, with a tendency of better improvement in group 1
firstly treated with Ectoin Allergy Nasal Spray. The second week of
treatment (after crossover) further improved the congestion, but no
significant changes occurred for both groups compared to visit 2.
Effect on Errhine
Score Significance
visit 3
vs. visit 1
6.20
group 1
5,8 5,64
Errhine Score
8
7
6
5
4
3
2
1
0
5,72 5,68
group 1
**
**
2,56
2,14
visit 1
visit 2
group 2
1,8 1,91
visit 3
The use of both nasal sprays significantly reduced the frequency
of sneezing after one weeks of treatment. The second week of
treatment led to more, but not significant, reduction.
Ectoin® is a registered trademark of bitop AG, all rights reserved.
To improve readability the ® has been omitted.
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