Mometasone Furoate Nasal Spray Improves Congestion Associated With Seasonal Allergic Rhinitis: Presented at EAACI

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Title: Mometasone Furoate Nasal Spray Improves Congestion Associated With Seasonal Allergic Rhinitis: Presented at EAACI
URL: http://www.pslgroup.com/dg/22359E.htm
Doctor's Guide
June 10, 2008

By Chris Berrie

BARCELONA, Spain -- June 10, 2008 -- Mometasone furoate nasal spray (MFNS) reduces nasal congestion significantly and rapidly after ragweed-pollen exposure in patients with seasonal allergic rhinitis, according to results presented here at the 27th Congress of the European Academy of Allergology and Clinical Immunology (EAACI).

Lead author Anne Marie Salapatek, PhD, Allied Research International, Cetero Research, Mississauga, Ontario, presented findings here on June 8 from a randomised, double-blind, parallel-group, phase 4 study, in which she and colleagues used acoustic rhinometry to evaluate the efficacy of treatment with MFNS.

The aim of the study was to evaluate the effect of MFNS 200 mcg on nasal cavity congestion (measured as a minimal cross-sectional area [MCA] determined by acoustic rhinometry) following exposure to ragweed pollen in an environmental-exposure chamber (EEC).

The study evaluated 310 patients with a history of seasonal allergic rhinitis of 2 or more years, positive skin test for ragweed allergen, and total nasal symptoms score (TNSS) of 2 or greater. TNSS assessment includes rating 4 different symptoms -- nasal discharge/runny nose, congestion, sneezing, and itching -- each on a 4-point scale, from 0 (none) to 3 (severe). The sum of the 4 symptom ratings creates a total scale with a 16-point range.

Patients in this study had a minimum baseline TNSS score of 6 and a minimum congestion score of 2 after 2 EEC priming visits. The mean age of the subjects was 38 years (range, 18-65 years). MCAs were measured in both nostrils.

On day 1 of treatment, all patients underwent controlled ragweed-pollen exposure (3,500 particles/m³) for 1.5 hours. After that exposure, 155 patients were randomised to placebo and 155 to MFNS 200 mcg. Subsequent EEC visits administered the same exposure, also lasting 1.5 hours.

Acoustic rhinometry was performed before each EEC exposure and at 2.5, 4.5, and 6.5 hours postdose.

A subset of 77 patients continued on placebo and 78 on MFNS 200 mcg for 7 days. On day 8 all of these subjects underwent acoustic rhinometry before a further 4 hours of EEC exposure, and then after 2.5 and 4.5 hours. Adverse events were recorded throughout the study.

Prior to EEC exposure, the mean absolute minimum MCAs were not significantly different between the control and MFNS groups (0.3706 vs 0.3875 cm³, respectively).

On day 1, after 2 hours predose pollen exposure, the MCAs were both similarly and significantly decreased (0.2977 vs 0.2828 cm³, P < .0001 for both). At 6 hours postdose, the placebo group had significantly more congestion than the MFNS group (0.2724 vs 0.3210 cm³, P = .005).

On day 8, 24 hours after final dosing and before further EEC exposure, congestion was significantly higher in the placebo group versus the active treatment group (0.3080 vs 0.3593 cm³, P = .04), which continued to 2 hours postexposure (0.2856 vs 0.3537 cm³, P = .01) and 4 hours postexposure (0.2593 vs 0.3532 cm³, P = .001).

Acoustic rhinometry, stated Dr. Salapatek, is objective, accurate, and reproducible (with a coefficient of variation of about 3%) for assessing nasal cavity geometry as MCA. It is an excellent way to determine nasal patency and congestion, she added.

The researchers found that MFNS was well tolerated, and that most adverse effects were mild or moderate. Adverse effects seen in more than 1 patient included headache, nausea, and pharyngolaryngeal pain across all treatment groups.

In confirming the efficacy of MFNS, Dr. Salapatek stressed that her team, "showed the earliest onset of action of [mometasone furoate] that has ever been shown. After a single dose of intranasal corticosteroids it showed an onset of action, using this objective measure of nasal congestion, [at] 6 hours."

The demonstrated therapeutic effect continued even at trough levels of MFNS.

Funding for this study was provided by Schering-Plough Corporation.

[Presentation title: Mometasone Furoate Nasal Spray Improves Congestion in Subjects With Seasonal Allergic Rhinitis as Measured Objectively With Acoustic Rhinometry. Abstract P195]

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