EFFECTIVENESS AND SAFETY OF INTRANASAL IPRATROPIUM BROMIDE IN COMMON COLDS - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Objective: To determine the tolerability and clinical effectiveness of intranasal ipratropium bromide for the treatment of symptoms of commo n colds. Design: Multicenter, double-blind, randomized trial. Setting: 3 university student health services. Patients: 411 previously health y persons 14 to 56 years of age who had cold symptoms that had lasted for no more than 36 hours, rhinorrhea subjectively judged to be of at least moderate severity, and documented nasal discharge of at least 1. 5 g over a 1-hour observation period. Intervention: Either 1) ipratrop ium bromide nasal spray 0.06% in buffered salt solution, two 42-mu g s prays per nostril administered by metered pump spray; 2) control nasal spray, which consisted of buffered salt solution; or 3) no treatment. Treatments were self-administered three or four times daily during wa king hours for 4 days. After receiving their morning dose, patients st ayed at the study center for 6 hours on study day 1 and 3 hours on stu dy day 2; symptom severity was recorded and nasal mucus discharges wer e collected and weighed hourly during these periods. Results: Ipratrop ium recipients had 26% less nasal discharge than controls (P = 0.0024) and 34% less nasal discharge than untreated patients (P = 0.0001). Se verity of rhinorrhea as judged subjectively was reduced in ipratropium recipients by 31% compared with controls and by 78% compared with unt reated patients (P = 0.0001 for both comparisons). in addition to bein g associated with reductions in daily assessments of the severity of r hinorrhea (P less than or equal to 0.003), ipratropium was associated with reduced sneezing on study days 2 (20% difference; P = 0.03) and 4 (30% difference; P = 0.02) but not with reduced nasal congestion comp ared with the control spray. Ipratropium was generally well tolerated but was associated with higher rates of blood-tinged mucus (16.8% in t he ipratropium group compared with 3.6% in the control group; P = 0.01 ) and nasal dryness (11.7% in the ipratropium group compared with 3.6% in the control group; P = 0.021) than the control spray. Patient asse ssments off the overall effectiveness of treatment were more favorable for ipratropium than for the control spray (P less than or equal to 0 .026) or for no treatment (P less than or equal to 0.002) on each day of inquiry; (study days 1, 2, and 5). Conclusions: Intranasal ipratrop ium bromide provides specific relief of rhinorrhea and sneezing associ ated with common colds.