Tilarin in combination with astemizole

Area of Science:

• Allergy and Immunology
• Pharmacology
• Respiratory Medicine

Background:

• Seasonal allergic rhinitis (SAR) is commonly treated with oral antihistamines in primary care.
• Allergy specialists often prefer combination therapy, including anti-inflammatories, for SAR management.
• The study addresses the efficacy of adding an anti-inflammatory nasal spray to an oral antihistamine.

Purpose of the Study:

• To evaluate if nedocromil sodium 1% nasal spray improves SAR symptom control when combined with astemizole tablets.
• To compare the efficacy of combination therapy (nedocromil sodium + astemizole) versus astemizole monotherapy.
• To assess the impact on symptom severity and the need for rescue medication during ragweed pollen season.

Main Methods:

• Multicentre, double-blind, placebo-controlled study with a 1-week baseline.
• Randomized assignment to four weeks of treatment: nedocromil sodium nasal spray + astemizole, placebo nasal spray + astemizole, or double-dummy placebo.
• Patient diary cards and clinical assessments recorded symptom severity and medication use.

Main Results:

• Both astemizole alone and combination therapy significantly reduced rhinitis symptoms compared to placebo (p < 0.001).
• Combination therapy showed significantly greater symptom reduction than astemizole alone (p < 0.01).
• Physician and patient assessments favored the combination therapy for symptom control (p = 0.011 and p = 0.003, respectively).

Conclusions:

• Combination therapy with nedocromil sodium nasal spray and astemizole tablets is superior to antihistamine monotherapy for allergic rhinitis.
• The combined treatment provided rapid symptom relief and was well-tolerated.
• No serious adverse events or significant changes in blood or urine parameters were observed.