title: Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients.
abstract: BACKGROUND
  Over-the-counter phenylephrine hydrochloride (PEH) is used for relief of nasal congestion caused by allergic rhinitis; however, data to support its efficacy are lacking. The US Food and Drug Administration recommended clinical trials to evaluate the efficacy and safety of PEH in patients with this condition.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of PEH 30-mg modified-release (MR) tablets in patients with nasal congestion caused by allergic rhinitis in a multicenter, randomized, double-blinded, placebo-controlled, 2-arm, parallel-group study.
  
  
  METHODS
  Eligible adults at least 18 years old with documented hypersensitivity to fall pollen allergens were randomized to PEH-MR or placebo every 12 hours for 7 days from August 30 to October 12, 2011. The primary end point was mean change from baseline during the entire treatment period in daily reflective nasal congestion score. Secondary end points included changes in other symptom score assessments, time to maximal effect, duration of effect, and quality of life. Safety assessments included adverse events, serious adverse events, vital signs, physical examination, and electrocardiograms.
  
  
  RESULTS
  Of 575 patients, 288 received PEH-MR and 287 received placebo. No significant beneficial difference was detected between PEH-MR and placebo for the primary end point (PEH-MR, mean -0.394, SD 0.4880; placebo, mean -0.412, SD 0.5383; P = .2655). Likewise, no significant differences were observed for most secondary end points or quality of life. Overall, 89 of 575 patients (15.5%), equally distributed between the PEH-MR and placebo groups, experienced at least 1 treatment-emergency adverse event.
  
  
  CONCLUSIONS
  PEH-MR 30-mg tablets taken orally every 12 hours for 7 days is not more efficacious than placebo in relieving nasal congestion caused by allergic rhinitis.
  
  
  BACKGROUND
  clinicaltrials.gov, identifier NCT01413958, protocol CL2011-06.
authors.affiliation: Allergy and Asthma Medical Group and Research Center, San Diego, California.
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.affiliation: Sylvana Research, San Antonio, Texas.
authors.forename: Paul H
authors.initials: PH
authors.lastname: Ratner
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey. Electronic address: thomas_p_mcgraw@yahoo.com.
authors.forename: Thomas
authors.initials: T
authors.lastname: McGraw
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014663:Nasal Decongestants / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010656:Phenylephrine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D013607:Tablets; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D014663:Nasal Decongestants; D013607:Tablets; D010656:Phenylephrine