Analgesic and decongestant efficacy of the combination of aspirin with pseudoephedrine in patients with symptoms of upper respiratory tract infection

Abstract

The study investigated the efficacy and safety of a combination therapy of 1,000mg aspirin (ASA) and 60mg pseudoephedrine (PSE) on the symptoms of pain (combined score for headache and sore throat) and nasal congestion in 833 patients with acute upper respiratory tract viral infection (URTI), over 4hours after a single dose in the clinic and over 3 days with multiple doses at home. The study demonstrated that over 4hours in the clinic the combination ASA plus PSE was superior to PSE or placebo for relief of pain symptoms measured subjectively with pain scores, and was superior to ASA or placebo for relief of nasal congestion as measured objectively with rhinomanometry and subjectively with congestion scores. After 3 days of treatment, ASA plus PSE was superior to PSE but not to placebo or ASA for global pain assessments, and ASA plus PSE was superior to ASA and placebo but not to PSE for congestion assessments. No unexpected adverse events occurred and no serious adverse events were attributed to study medicines. This study demonstrates that a combination therapy of ASA plus PSE provides safe and effective relief of both common cold pain related symptoms and nasal congestion. © 2013 The Authors. Clinical Pharmacology in Drug Development published by Wiley on behalf of The American College of Clinical Pharmacology.