OTC use of a topical nasal spray solution containing xylometazoline plus ipratropium in patients with common cold.

BACKGROUND: Combination of xylometazoline and ipratropium in a nasal spray provides fast, effective symptomatic relief of nasal congestion and rhinorrhea in adults with common cold.

OBJECTIVES: To gather data in a non-prescription setting regarding the safety, pattern of use, patients' general assessment of treatment and suitability of making available without medical prescription of this topical combination nasal spray.

DESIGN: Post-marketing, non-interventional, non-controlled study reflecting normal over-the-counter (OTC) use of the spray in adults with common cold (n = 1,019). Main outcome measures included pattern of use (patient-reported effectiveness, compliance with treatment) and safety (adverse drug reaction (ADR) reports).

RESULTS: Over 92% of patients used the product for the intended indication, 81.4% used it 2 - 3 times/day and the median duration of treatment was 6 days. In total, 39.7% of patients reported 585 ADRs (mean 1.45 ADR/patient) while 60.3% reported no ADRs. Most common side effects were nasal dryness (12.4%), blood tinged mucus (9.3%), nasal discomfort (6.2%), epistaxis (4.2%), generally harmless and of mild severity. Patients who used the product outside the approved indication did not seem to have a higher risk of ADRs. Mean general impression score was 3.4, with 79% of patients rating treatment as "good" to "excellent".

CONCLUSIONS: The topical combination nasal spray (xylometazoline plus ipratropium) for the symptomatic relief of nasal congestion and rhinorrhea in adults with common cold has a good safety profile and results in high patient satisfaction in an OTC setting. No reasons could be found to oppose the assertion that the combination spray is suitable for classification as a product not subject to medical prescription.