Abstract |
A gel formulation of the antiallergic compound N-acetyl-aspartyl glutamic acid ( NAAGA) (Rhinaaxia (R)) has been evaluated in a multicenter, randomized, double-blind, three-arm, parallel-group comparison with placebo gel (P) and disodium cromoglycate (DSCG) in outpatients suffering from seasonal allergic rhinitis ( pollinosis). Nose and eye symptoms were assessed daily by the patients on visual analog scales (VAS), and medical examinations were held after 1 week and at the end of the 4-week treatment. The use of rescue medications (H1-antagonist ( terfenadine) and soothing eye-drops (Spersallerg) was recorded as a main assessment indicator of efficacy. For the efficacy analysis, only the periods with relevant pollen concentrations (> or = 50 grains/m3) were considered. The study extended over the two pollen seasons 1989 and 1990. Of 230 included patients, 190 were suitable for efficacy analysis (R = 63, P = 64, DSCG = 63). The VAS data did not reveal a difference between the treatment groups for nasal symptoms, whereas the use of terfenadine tablets was significantly lower in the Rhinaaxia group than in either the placebo (P = 0.0001) or DSCG group (P = 0.03). The eye symptoms were significantly less severe in the Rhinaaxia group than in both placebo (P = 0.0001) and DSCG (P < 0.01) groups. In addition, the use of rescue medication was significantly higher in the placebo than in the Rhinaaxia treatment group (P = 0.0001). The incidence of local untoward effects ( itching/burning sensation in the nose) was slightly higher in the Rhinaaxia group, while the overall tolerability assessment was similarly good in all three treatment groups.(ABSTRACT TRUNCATED AT 250 WORDS)
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Authors | M A Althaus, W J Pichler |
Journal | Allergy
(Allergy)
Vol. 49
Issue 3
Pg. 184-8
(Mar 1994)
ISSN: 0105-4538 [Print] Denmark |
PMID | 7911011
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Dipeptides
- Gels
- Histamine H1 Antagonists
- Ophthalmic Solutions
- isospaglumic acid
- Terfenadine
- Cromolyn Sodium
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Topics |
- Administration, Intranasal
- Adolescent
- Adult
- Analysis of Variance
- Cromolyn Sodium
(therapeutic use)
- Dipeptides
(therapeutic use)
- Double-Blind Method
- Female
- Gels
- Histamine H1 Antagonists
(therapeutic use)
- Humans
- Male
- Middle Aged
- Ophthalmic Solutions
- Rhinitis, Allergic, Seasonal
(drug therapy)
- Severity of Illness Index
- Switzerland
- Terfenadine
(therapeutic use)
- Time Factors
- Treatment Outcome
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