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| EFFICACY AND SAFETY OF LECTRANAL® IN THE TREATMENT OF SEASONAL ALLERGIC RHINITIS SYMPTOMS |
| In order to determine efficacy and safety of Lectranal® in the treatment of seasonal allergic rhinitis symptoms, a randomized, double-blind, placebo controlled clinical study was conducted in Dubrava University Hospital in Zagreb. |
METHODS
A group of 48 adult patients, each with a history of seasonal allergic rhinitis symptoms caused by pollen and a positive skin prick test for pollen, were enrolled in the study, out of which 41 completed it according to protocol. Patients allergic to a specific pollen were divided into two groups randomly. One group was administered two Lectranal® capsules twice a day and the other received a placebo for a period of 6 weeks during pollen season. The primary and secondary endpoints consisted of the changes observed in the following: a SARS questionnaire (seasonal allergic rhinitis symptoms), a Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire), a skin-prick test, specific IgE and IgG values, and eosinophilia in nasal secretion. The methods used for safety evaluation included a side effects report, physical examination, and the taking of vital signs. |
RESULTS
Overall treatment success
At the end of the trial, the physician and the patients separately evaluated the overall success of the treatment by describing the change in their symptoms as: worse (1), no change(2), little improvement (3), moderate improvement (4), and significant improvement (5). In the Lectranal® group, 78.6% of the patients experienced significant or moderate improvement according to the physician's assessment. In the placebo group, improvement was evaluated by the physician as moderate in 38.5% of the patients. According to the physician, in the placebo group none of the patients had significant improvement, compared to 38.7% of the patients in the Lectranal® group.
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 Overall treatment effect after 6 weeks compared to placebo, evaluated by physician (p= 0.017) |
At the same time, 71.4% of the patients in the Lectranal® group reported significant or moderate improvement, as compared to 53.9% of the patients in the placebo group. None of the patients in the placebo group reported significant improvement, as compared to 35.5% of the patients in the Lectranal® group who evaluated treatment by the highest grade 5 (significant improvement). |
 Overall treatment effect after 6 weeks compared to placebo, evaluated by patient (p=0,016) |
During the ragweed (Ambrosia artemisifolia) season, the average grade for the efficiency of the treatment was 4.71 for Lectranal®, compared to 3.00 for the placebo, according to the physician's evaluation, and 4.71 and 3.23 respectively for Lectranal® and the placebo, according to the patients' evaluations. |
 Comparison of overall treatment effect during ragweed season after 6 weeks according to the physician's evaluation (p= 0.0002) |
 Comparison of overall treatment effect during ragweed season after 6 weeks according to the patients' evaluations (p= 0.001) |
These results correlate significantly with the reduction in the SARS and Mini RQLQ scores, as well as the reduction in the intensity of the individual symptoms. |
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