A new lipid-based nasal ointment effective at reducing symptoms of allergic rhinitis

Sep 18 2004

One in five Americans have allergic rhinitis, a number that is steadily rising, but the exact reasons for this increase are unknown. A new lipid-based nasal ointment is found effective at reducing symptoms of allergic rhinitis in German patients.

Allergic rhinitis is characterized by an inflammatory response that occurs mainly in the mucous membranes of susceptible individuals after contact with trigger allergens. The results are symptoms such as sneezing, itching of the nose, throat, eyes and ears, excess secretion of tears, nasal congestion and discharge, and swelling of the eyes.

Allergic rhinitis can be seasonal – responding to grain or grass pollen – or perennial, caused by exposure and contact to nonseasonal allergens found, for example, in animals and house dust. Perennial allergic rhinitis produces symptoms similar to those of seasonal allergic rhinitis, but nasal congestion is the chief complaint and conjunctivitis, or swelling of the eyes, is less common.

Antihistamines and corticosteroids are frequently used to relieve the symptoms of allergic rhinitis. These medications are associated with a low rate of side effects. Some believe that chemically and physiologically inert nasal ointments, such as the one investigated in the present study, are interesting options for adjuvant treatment of allergic rhinitis for symptom relief.

German researchers set out to assess the efficacy of a high-viscosity, lipid-based nasal ointment in the treatment of allergic rhinitis based on the observed change in the overall symptom picture. The authors of “Lipid-based Nasal Ointment for Allergic Rhinitis,” are Urban Wilhelm Geisthoff MD, Marianne Rupp-Classen MD, and Peter-Karl Plinkert MD, from the ENT Department of the University of the Saarland, Homburg/Saar; and Andreas Blum MD, at the ENT Department of the University Hospital Mannheim, Mannheim, all in Germany. Their findings are being presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation Annual Meeting & OTO EXPO, being held September 19-22, 2004, at the Jacob K. Javits Convention Center, New York City, NY.

Methodology:

This prospective, randomized, open, parallel-group comparison of 33 treated and untreated allergic rhinitis patients occurred at two centers in Germany. The study was conducted in two phases: first, a seven day preliminary assessment phase which included screening to determine patient inclusion; the second and main phase of the study consisted of 14 days of treatment at one of the two study centers (Mannheim or Homburg) after random assignment of a patient to the treatment or control group. The study was conducted from March 2002 to July 2002. Only those patients with sufficiently severe symptoms of sneezing, nasal itching, rhinorrhea, and nasal congestion were included.

The treatment group (of 17 patients) was given an adequate supply of the investigational product containing a significant percentage of long-chain hydrocarbons. Those in the control groups (16 patients) did not receive any investigational product. Using a finger or a cotton swab, each patient in the treatment groups applied a roughly 1 cm long strip of the investigational product to each nostril and evenly spread the ointment in the anterior portion of the nose. The ointment was applied every three to five hours except while the patient was sleeping, and could be applied more frequently if necessary.

Each patient was requested to keep separate diaries for the preliminary assessment phase and the actual treatment period using the same rules for logging entries during both investigational periods.

Apart from logging the individual symptom scores, each patient was also requested to make a record of all concomitant medications, including their type, dose, and route of administration, duration of treatment (beginning and end), and any prior treatments in the patient diaries. The patient's general state of health before and after completion of the study was also recorded in the patient diaries. On completion of treatment, each patient received a final examination during which the primary and secondary efficacy variables were again assessed.

The primary efficacy variable was the change in allergy symptoms, as defined by each patient’s mean relative total symptom score (TSS), which was obtained by dividing the difference between the Week 3 and Week 1 scores by the Week 1 score and multiplying the result by 100: Relative TSS = (TSS Week 3 – TSS Week 1) / TSS Week 1 x 100.

Results:

When questioned about their personal allergy history, 18 patients reported seasonal symptoms of allergic rhinitis, 12 mixed seasonal/perennial symptoms, and three perennial symptoms. The most frequent causative allergens, in order of prevalence, were grass/cereal, tree, weed and animal allergens including feathers, followed by mite allergens.

A significant reduction in the total symptom score (TSS), which was based on the four parameters sneezing, nasal itching, rhinorrhea, and nasal congestion was found, indicating that the lipid-based nasal ointment effectively reduced allergy symptoms.

Conclusions:

The investigational product used in the present study is a mixture of high-purity, long-chain hydrocarbons in a high-viscosity mineral oil base. Long-chain mineral hydrocarbons are a subject of controversy in rhinology. Concerns have been expressed regarding the possible presence of postoperative paraffin granulomas following sinus surgery; additionally, there have been case reports of lipoid pneumonia in association with long-term, night-time intranasal application of a mineral oil-based nasal ointment. The latter risk was considered but deemed minimal due to the significantly lower spreading tendency in the mucosa of our product owing to its composition characteristics.

With these reservations, the researchers determine that the lipid-based nasal ointment led to a significant reduction of allergic rhinitis symptoms in patients in the treatment group, while the symptoms of the untreated controls remain unchanged. The cause of the ointment’s effectiveness has yet to be determined.