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A randomized, double-blind, parallel-group, multicenter, placebo-controlled study of the safety and efficacy of extended-release guaifenesin/pseudoephedrine hydrochloride for symptom relief as an adjunctive therapy to antibiotic treatment of acute respiratory infections.

AbstractPURPOSE:
This study assessed the efficacy and safety of guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg extended-release bilayer tablets in providing relief of acute respiratory symptoms when used as an adjunct to antibiotics in patients with an acute respiratory infection (ARI).
METHODS:
Adult patients experiencing symptoms of ARI and meeting the physician's usual diagnostic criteria for oral antibiotic treatment were prescribed an antibiotic and randomized to adjunctive guaifenesin/pseudoephedrine hydrochloride or matching placebo twice daily for 7 days. Patients completed symptom diaries and treatment assessments twice daily and attended office visits on Days 4 and 8.
RESULTS:
The safety/intent-to-treat (ITT) population analysis included 601 patients (guaifenesin/pseudoephedrine, n = 303; placebo, n = 298). Mean symptom scores were lower with guaifenesin/pseudoephedrine from Day 3 for every symptom assessed, with statistically significant improvements in total symptom score from Day 3 (P = 0.026). The greatest effects of treatment with guaifenesin/pseudoephedrine were observed for nasal congestion and sinus headache. Time to overall relief was shorter with guaifenesin/pseudoephedrine (P = 0.038). Significantly more patients reported "the medication was helping during the day" on Day 2 with guaifenesin/pseudoephedrine (P = 0.002). Patient assessments of symptom relief showed a significant preference for guaifenesin/pseudoephedrine versus placebo (P = 0.021). Treatment with guaifenesin/pseudoephedrine was well tolerated. Insomnia (2.6%), nausea (2.3%), and headache (1.3%) were the most common treatment-related adverse effects.
CONCLUSIONS:
As adjunctive therapy for symptom relief for patients taking antibiotics for ARIs, guaifenesin/pseudoephedrine shortened time to relief and improved bothersome respiratory symptoms better than placebo, with greatest effects seen for nasal congestion and sinus headache.
AuthorsCraig LaForce, Deborah A Gentile, David P Skoner
JournalPostgraduate medicine (Postgrad Med) Vol. 120 Issue 2 Pg. 53-9 (Jul 2008) ISSN: 1941-9260 [Electronic] England
PMID18654069 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Bacterial Agents
  • Delayed-Action Preparations
  • Drug Combinations
  • Expectorants
  • Nasal Decongestants
  • Guaifenesin
  • Pseudoephedrine
Topics
  • Administration, Oral
  • Adult
  • Anti-Bacterial Agents (therapeutic use)
  • Delayed-Action Preparations
  • Double-Blind Method
  • Drug Combinations
  • Expectorants (administration & dosage)
  • Female
  • Guaifenesin (administration & dosage)
  • Humans
  • Male
  • Middle Aged
  • Nasal Decongestants (administration & dosage)
  • Pseudoephedrine (administration & dosage)
  • Respiratory Tract Infections (complications, drug therapy)
  • Treatment Outcome

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