Nasal Decongestant Activity of Pseudoephedrine

Abstract

The effectiveness of orally administered pseudoephedrine in patients with acute or chronic nonsuppurative rhinitis was evaluated under double-blind conditions. Intranasally administered ephedrine which was given to all patients at the end of this study served as the positive control. Marked nasal decongestant effects of a single oral dose of pseudoephedrine (60 mg tablet), as determined by a modified passive anterior, rhinometric technique occurred within 30 minutes and were maintained for at least four hours. The mean nasal decongestant response (delta % of baseline) of 57.2% was associated with a mean peak, plasma pseudoephedrine level of 274 ng/ml. In addition, the maximum response to oral pseudoephedrine treatment was equivalent to the response produced by ephedrine nasal spray. These results suggest that pseudoephedrine is an orally, effective nasal decongestant.

Factors associated with efficacy of an ibuprofen/pseudoephedrine combination drug in pharmacy customers with common cold symptoms

“…While we are not aware of previous studies exploring time to onset of symptom relief with ibuprofen/pseudoephedrine combinations, these values are in line with previous, placebo‐controlled studies on pseudoephedrine monotherapy in common cold patients, being based on subjective symptom relief3, 4, 14 or on objective measurements of nasal airway flow or resistance 4, 10, 14, 15, 18. They are also in line with the pharmacokinetic properties of pseudoephedrine which reaches t max at about 60 minutes with almost maximum plasma concentrations being observed at 30 min (earliest measured time point)6, 16; t max of ibuprofen is also seen after about 60 minutes 6. Therefore, our data based on subjective assessment with an ibuprofen/pseudoephedrine combination product in an open‐label setting together with previous subjective, objective and pharmacokinetic results from placebo‐controlled studies testify a fast time to onset of symptom relief.…”

“…Thus, typical ibuprofen‐responsive symptoms were approved to a slightly greater extent than typical pseudoephedrine‐responsive or non‐specific symptoms, which is reflected in the operationally defined symptoms scores used in our analysis. The overall extent of improvement is comparable to values reported in placebo‐controlled trials, for instance for the degree of nasal congestion reduction with a 60 mg dose of pseudoephedrine 16 or the degree of reduction in nasal, throat and systemic symptoms with a 200 mg ibuprofen/60 mg pseudoephedrine combination 7…”

“…Specifically, pseudoephedrine was found to reduce subjective or objective measures of congestion3, 8, 10, 16 but has little effect on sneezing,8 on pain10 or on non‐congestion cold symptoms in general 3. In the present survey, the ibuprofen/pseudoephedrine combination product differentially affected the extent of intra‐individual improvement of specific symptoms.…”

“…To reflect real‐world conditions a patient survey was performed, which excludes a placebo group. This was not deemed necessary as the efficacy of ibuprofen,6 pseudoephedrine3, 6, 7, 8, 10, 14, 15, 16, 17, 18 or their combination6, 7 in the treatment of common cold symptoms has been established in multiple placebo‐controlled studies. Moreover, common cold sufferers had correctly identified whether they were on active treatment or placebo in previous studies,8 questioning the value of a placebo group in this indication.…”

“…In contrast, data on duration of symptom relief after the first dose of medication are not easy to explain in the absence of a placebo group in the light of the natural course of the condition. However, rhinomanometry3 as well as pharmacokinetic studies16 support the concept of a dosing interval of 6 hours.…”