title: Effectiveness of 0.05% oxymetazoline (Vicks Sinex Micromist®) nasal spray in the treatment of objective nasal congestion demonstrated to 12 h post-administration by magnetic resonance imaging.
abstract: BACKGROUND
  This study aimed to assess the qualitative and quantitative utility of MRI imaging to illustrate the magnitude and duration of the effect of a standard 100 μg dose of oxymetazoline in a commercially available formulation that also contains aromatic oils.
  
  
  METHODS
  This was a randomized, open label, single dose, parallel group study in 21 adult male and female subjects who reported moderate to severe nasal congestion due to acute upper respiratory tract infection or hay fever. MRI scans were acquired using a 3T Philips Achieva scanner with a 16 channel head receive coil. High resolution MRI scans of the nasal turbinates were obtained immediately prior to dosing (baseline) and at approximately 1, 8, 10, 11, and 12 h after dosing. The efficacy variables of primary interest were inferior turbinate total volume at 8 and 12 h post-dosing. The secondary efficacy variables analysed were inferior turbinate total volume at 1, 10, and 11 h post-dosing, middle turbinate total volume at 1, 8, 10, 11, and 12 h post-dosing.
  
  
  RESULTS
  Changes from baseline volumes measured for the inferior and middle turbinates of subjects receiving the oxymetazoline formulation showed significant (P < 0.05) decreases at all times up to and including 12 h post-administration. No significant decreases from baseline were detected in subjects receiving a sham 'spray' (untreated control - spray bottles with no spray solution). Statistical ANCOVA results of inferior and middle turbinate volume indicated significant differences (P < 0.05) at all measurement points up to and including 12 h post-administration between the oxymetazoline treatment group and the untreated control with the only exception the middle turbinate volume at 10 h (P = 0.0896). The significant changes were likely to be clinically relevant though this was not measured in the study. No AEs were reported during this study and no other safety evaluations were made.
  
  
  CONCLUSIONS
  This study showed that MRI assessment of nasal congestion in human volunteers is a robust, repeatable and viable measurement technique. The application of a 100 μg Vicks Sinex Micromist(®) nasal decongestant (0.05% oxymetazoline solution) delivered a highly significant reduction in inferior and middle turbinate volumes compared with the application of a control, measurable by the MRI method up to and including a 12 h post-dose scan.
authors.affiliation: Sir Peter Mansfield Magnetic Resonance Centre, School of Physics and Astronomy, The University of Nottingham, Nottingham, UK. Electronic address: Susan.Pritchard@nottingham.ac.uk.
authors.forename: S
authors.initials: S
authors.lastname: Pritchard
authors.affiliation: Division of Therapeutics and Molecular Medicine, University of Nottingham, UK.
authors.forename: M
authors.initials: M
authors.lastname: Glover
authors.affiliation: Division of Therapeutics and Molecular Medicine, University of Nottingham, UK.
authors.forename: G
authors.initials: G
authors.lastname: Guthrie
authors.affiliation: Procter & Gamble, Mason, OH, USA.
authors.forename: J
authors.initials: J
authors.lastname: Brum
authors.affiliation: Procter & Gamble, Mason, OH, USA.
authors.forename: D
authors.initials: D
authors.lastname: Ramsey
authors.affiliation: Procter & Gamble, Mason, OH, USA.
authors.forename: G
authors.initials: G
authors.lastname: Kappler
authors.affiliation: Procter & Gamble, Mason, OH, USA.
authors.forename: P
authors.initials: P
authors.lastname: Thomas
authors.affiliation: Procter & Gamble, Whitehall Lane, Egham, Surrey, UK.
authors.forename: S
authors.initials: S
authors.lastname: Stuart
authors.affiliation: Procter & Gamble, Whitehall Lane, Egham, Surrey, UK.
authors.forename: D
authors.initials: D
authors.lastname: Hull
authors.affiliation: Sir Peter Mansfield Magnetic Resonance Centre, School of Physics and Astronomy, The University of Nottingham, Nottingham, UK.
authors.forename: P
authors.initials: P
authors.lastname: Gowland
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D014663:Nasal Decongestants / Q000008:administration & dosage / Q000627:therapeutic use*; D015508:Nasal Obstruction / Q000188:drug therapy* / Q000209:etiology; D059085:Nasal Sprays; D010109:Oxymetazoline / Q000008:administration & dosage / Q000627:therapeutic use*; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D013997:Time Factors; D055815:Young Adult
chemical_list: D014663:Nasal Decongestants; D059085:Nasal Sprays; D010109:Oxymetazoline
keywords: Long-lasting; MRI; Nasal turbinates; Oxymetazoline; Volume measurement