Clinical Trial of 3 Days of Treatment with Oral Pseudoephedrine for the Common Cold in the Southern Hemisphere

Latte, Jenny; Taverner, David

doi:10.2500/ajr.2007.21.3041

Cited by 10 publications

(7 citation statements)

References 5 publications

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“…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.…”

Section: Discussionsupporting

confidence: 82%

“…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.…”

Section: Discussionmentioning

confidence: 99%

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

Klimek

Schumacher²,

Schütt

et al. 2016

Int J Clin Pract

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SummaryAimThe aim of this study was to explore factors affecting efficacy of treatment of common cold symptoms with an over‐the‐counter ibuprofen/pseudoephedrine combination product.MethodsData from an anonymous survey among 1770 pharmacy customers purchasing the combination product for treatment of own common cold symptoms underwent post‐hoc descriptive analysis. Scores of symptoms typically responsive to ibuprofen (headache, pharyngeal pain, joint pain and fever), typically responsive to pseudoephedrine (congested nose, congested sinus and runny nose), considered non‐specific (sneezing, fatigue, dry cough, cough with expectoration) and comprising all 11 symptoms were analysed. Multiple regression analysis was applied to explore factors associated with greater reduction in symptom intensity or greater probability of experiencing a symptom reduction of at least 50%.ResultsAfter intake of first dose of medication, typically ibuprofen‐sensitive, pseudoephedrine‐responsive, non‐specific and total symptoms were reduced by 60.0%, 46.3%, 45.4% and 52.8%, respectively. A symptom reduction of at least 50% was reported by 73.6%, 55.1%, 50.9% and 61.6% of participants, respectively. A high baseline score was associated with greater reductions in symptom scores but smaller probability of achieving an improvement of at least 50%. Across both multiple regression approaches, two tablets at first dosing were more effective than one and (except for ibuprofen‐sensitive symptoms) starting treatment later than day 2 of the cold was generally less effective.Discussion and ConclusionsEfficacy of an ibuprofen/pseudoephedrine combination in the treatment of common cold symptoms was dose‐dependent and greatest when treatment started within the first 2 days after onset of symptoms.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

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

Klimek

Schumacher²,

Schütt

et al. 2016

Int J Clin Pract

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“…There is no marketed cure for the common cold and symptomatic therapy is the only treatment option for nasal congestion. To this end, numerous oral and topical over-the-counter (OTC) decongestant drugs have been marketed for both adults and children 21 . A well known and commonly used decongestant is xylometazoline hydrochloride nasal spray, used alone (marketed as Otrivin Õ nasal spray) or in combination with ipratropium bromide (used to reduce rhinorrhoea) (Otrivin Complete/Otrivin Comp/Otrivin Duo/ OtriDuoy).…”

Section: Introductionmentioning

confidence: 99%

Effects of intranasal xylometazoline, alone or in combination with ipratropium, in patients with common cold

Eccles

Martensson

Chen

2010

Current Medical Research and Opinion

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“…Given that the common cold is a generally mild condition that is transient and self‐limiting and that nasal congestion appears to follow diurnal variation, being worse in the morning and better in the early evening, distinguishing between a high placebo response and drug‐induced changes in symptom severity and relief is challenging. Similarly, efficacy of pseudoephedrine compared with placebo in adult studies of the common cold has been demonstrated over the initial dose or doses on the first study day, but inconsistently demonstrated efficacy on subsequent days …”

Section: Study Limitationsmentioning

confidence: 99%

“…Similarly, efficacy of pseudoephedrine compared with placebo in adult studies of the common cold has been demonstrated over the initial dose or doses on the first study day, but inconsistently demonstrated efficacy on subsequent days. [17][18][19][20]…”

Section: Study Limitationsmentioning

confidence: 99%

A Multicenter, Randomized, Placebo‐Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold

Gelotte

Albrecht

Hynson³

et al. 2019

The Journal of Clinical Pharma

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This multicenter, double‐blind, placebo‐controlled, randomized study was designed to evaluate the efficacy and safety of pseudoephedrine hydrochloride 30‐mg tablets in children aged 6 to 11 years for the temporary relief of nasal congestion due to the common cold. The primary efficacy end point was the weighted sum of the change from baseline in instantaneous nasal congestion severity score over the period from 1 to 8 hours following the first dose of study drug on day 1. Safety assessments included adverse events, sleepiness ratings, and vital signs. Pseudoephedrine was superior to placebo in reducing instantaneous nasal congestion severity in pediatric children over the first 8 hours after dosing on day 1 (least squares mean difference between treatment groups was 1.2; P = .029). Overall, secondary end points associated with nasal congestion were supportive on day 1, whereas secondary end points on day 2 were only numerically favorable. Somnolence was reported in a greater percentage of children on pseudoephedrine compared to placebo (71.9% vs 63.9%), while similar percentages of children in the same respective groups reported insomnia (34.4% and 38.9%) and nervousness (20.0% and 23.6%).Pseudoephedrine provides temporary relief of nasal congestion associated with the common cold in children 6 to <12 years of age at the current over‐the‐counter monograph dose. Multiple dosing of pseudoephedrine for up to 7 days, when given as needed for symptom relief, was generally safe in this population of children with the common cold.

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Clinical Trial of 3 Days of Treatment with Oral Pseudoephedrine for the Common Cold in the Southern Hemisphere

Abstract: PSE showed small but nonsignificant improvements in objective assessments of nasal congestion relative to placebo after a single dose.

Cited by 10 publications

References 5 publications

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

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

Effects of intranasal xylometazoline, alone or in combination with ipratropium, in patients with common cold

A Multicenter, Randomized, Placebo‐Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold

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