Comparative randomised clinical study of tolerability and efficacy of Rhinomer Force 3 versus a reference product in post-operative care of the nasal fossae after endonasal surgery.

Twenty-eight patients undergoing rhinologic surgery were enrolled in a clinical study to compare two post-operative cleansing preparations. Patients were asked to wash their nasal fossae for 1 month, either with Rhinomer, a cleansing preparation of isotonic, sterile, undiluted sea water, presented in slightly pressurised bottle with neither CFC nor preservative, or with Prorhinel, a marketed solution containing an antiseptic agent. Patients were randomly allocated to treatment beginning 2 days after surgery. Nasal status was assessed by symptoms (blocking nose, rhinorrhoea, sneezing, itching and impaired smell) and rhinologic endoscopy (colour of the nasal mucosa, swelling of the mucosa, secretions, presence of crusts or pus). Patients attended control visits on days 9, 15 and 30 following surgery. They were asked to record symptom intensity and use of a rescue medication (Vibrocil, dimetindene 0.25 mg and phenylephrine 2.5 mg/ml) on a diary card. Twenty-six of 28 patients were eligible for efficacy analysis, 14 in the Rhinomer group and 12 in the Prorhinel group, In both groups, intensity of complaints decreased markedly over the study period. No severe adverse drug reactions were reported in either treatment. Evoked complaint frequency was comparable between groups, but patient's and physician's opinion on tolerability was significantly different between treatments, in favour of Rhinomer. In addition, the test preparation was found to be easier to use than Prorhinel. The weekly average frequency of use of the rescue medication was not significantly different between treatments. When both patients and physicians were asked about treatment efficacy, they expressed an opinion significantly more favourable to Rhinomer than to the reference drug. In this study, Rhinomer has shown efficacious results that justify its use in washing of the nasal cavities following endonasal surgery.

Effects of terfenadine and pseudoephedrine, alone and in combination in a nasal provocation test and in perennial rhinitis.

The effects of terfenadine and pseudoephedrine, alone and in combination, have been assessed in a nasal provocation test and in perennial rhinitis. In a double-blind, placebo-controlled cross-over nasal provocation test, twelve men allergic to grass pollen were treated with two daily doses of placebo, terfenadine 60 mg, pseudoephedrine 120 mg, or the combination of the two, for 2 days preceding each test. The allergic reaction threshold, based on rhinorrhoea, sneezing and nasal inspiratory peak flow rate, was raised significantly both by terfenadine and pseudoephedrine, and their effects appeared additive (repeated measures analysis of variance). In a double-blind, randomized clinical study of perennial rhinitis two parallel groups, the efficacy and tolerability of terfenadine and terfenadine-pseudoephedrine were compared in 50 patients. Symptoms and signs in both groups were improved after 14 days of treatment. Differences between groups showed a trend in favour of terfenadine-pseudoephedrine, for swelling of the nasal mucosa (rhinoscopy) they were statistically significant. Both medications were well tolerated overall, although adverse events and reactions were more frequent in the terfenadine-pseudoephedrine group. In conclusion, terfenadine-pseudoephedrine and its constituents taken alone were effective. The combination performed better, but adverse events were somewhat more frequent with the combination than with terfenadine alone.

Facial thermography during nasal provocation tests with histamine and allergen.

Changes of skin temperature (T degree) of the nose area during nasal provocation tests with histamine and allergen were followed by means of an infrared thermography camera. By a colimator system in which temperatures measured on a given surface can be integrated and averaged, thermography allows the continuous and quantitative recording of the temperature during the whole procedure in a completely noninvasive way. In 10 normal subjects, increasing doses of histamine induced a dose-dependent rise of the nose external temperature. No significant change was observed with the vehicle solution. In six subjects allergic to grass pollen, the nebulization of increasing concentrations of a pollen extract induced a dose-dependent rise in T degree. The T degree rise observed after histamine or allergen corresponded to a marked nasal obstruction. The nebulization of the highest dose of the pollen extract did not induce any T degree rise in six nonallergic subjects. The continuous recording of the skin temperature by a noninvasive method might yield additional information on the vascular changes rapidly occurring during nasal challenges.

Clinical evaluation of a new in-vitro assay for specific IgE, the immuno CAP system.

The Pharmacia CAP system is a new assay for specific IgE characterized by a new solid phase (hydrophilic polymer encased in a capsule). The CAP results were compared to those of the Phadebas IgE RAST and skin-prick tests (SPT) performed in 145 subjects suffering from rhinitis and/or asthma with eight common inhalant allergens (total number of tests = 1160). Concording CAP/RAST results were found in 91% of the tests. The CAP was positive in 78% and the RAST in 65% of the positive SPT. Conversely, the CAP was negative in 90.6% and the RAST in 96.4% of the negative SPT. A pattern negative SPT, negative RAST and positive CAP' was found in 56 tests (40 subjects): in four such subjects, the CAP positivity was confirmed by a positive IgE crossed radioimmunoelectrophoresis. Three borderline positive results were found among 240 negative controls (serum from cord blood or non-atopics). These data indicate that compared with SPT the CAP system is (a) more sensitive than the Pharmacia RAST and (b) does not seem less specific.

Once daily mometasone furoate aqueous nasal spray is as effective as twice daily beclomethasone dipropionate for treating perennial allergic rhinitis patients.

BACKGROUND: Perennial allergic rhinitis is chronic and persistent, may lead to a constellation of secondary complaints including sinusitis, mouth-breathing, and some symptoms resembling a permanent cold, and often requires constant medical intervention. Well-tolerated nasal corticosteroids, alone or in combination with antihistamines, have been found to be very effective in treating this condition. OBJECTIVE: To compare the effectiveness and tolerability of mometasone furoate aqueous suspension, a new once daily nasal spray, to placebo vehicle and to beclomethasone dipropionate, administered twice daily, in patients with perennial allergic rhinitis. METHODS: This was a randomized, double-blind, placebo-controlled, double-dummy, parallel group study, in 427 patients age 12 years and older at 24 centers in Canada and Europe. Patients allergic to at least one perennial allergen, confirmed by medical history, skin testing, and adequate symptomatology were eligible to receive one of the following regimens for 3 months: mometasone furoate, 200 micrograms only daily; beclomethasone dipropionate, 200 micrograms twice daily (400 micrograms total dose); or placebo vehicle control. The primary efficacy variable was the change from baseline in total AM plus PM diary nasal symptom score over the first 15 days of treatment. RESULTS: Three hundred eighty-seven patients were valid for efficacy. For the primary efficacy variable, mometasone furoate was significantly (P < or = .01) more effective than placebo and was indistinguishable from beclomethasone dipropionate. Similar trends were seen among individual symptoms, physician symptom evaluations, and therapeutic response. There was no evidence of tachyphylaxis. All treatments were well tolerated. CONCLUSIONS: Mometasone furoate nasal spray adequately controls symptoms of perennial allergic rhinitis, offers the advantage of once daily treatment, and is well tolerated.