Effects of sustained-release oral phenylpropanolamine on the nasal mucosa of healthy subjects.

Phenylpropanolamine (PPA) is widely used as a nasal decongestant administered orally in sustained release preparations and, in Sweden, the recommended dose nowadays is 50 mg twice daily for adults. The aim of this placebo-controlled, cross-over study was to determine the onset and duration of the de...

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Published in:Acta Oto-Laryngologica Vol. 119; no. 7; pp. 837 - 843
Main Authors: Graf P, Toll K, Palm J, Hallén H
Format: clinical trial research Journal Article
Published: Taylor & Francis Ltd 12/30/99
Online Access:View this record in EBSCOhost
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      dt: 12/30/99
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      pub: Taylor & Francis Ltd
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        atl: Effects of sustained-release oral phenylpropanolamine on the nasal mucosa of healthy subjects.
      aug:
        au:
          Graf P
          Toll K
          Palm J
          Hallén H
      sug:
        subj:
          Phenylpropanolamine Administration and Dosage
          Vasoconstrictor Agents, Nasal Administration and Dosage
          Administration, Intranasal
          Administration, Oral
          Adult
          Aerosols
          Blood Pressure Drug Effects
          Clinical Trials
          Crossover Design
          Delayed-Action Preparations
          Dose-Response Relationship, Drug
          Female
          Hypertension Chemically Induced
          Male
          Oxymetazoline Administration and Dosage
          Oxymetazoline Adverse Effects
          Phenylpropanolamine Adverse Effects
          Vasoconstrictor Agents, Nasal Adverse Effects
          Human
          Adult: 19-44 years
          Female
          Male
      ab: Phenylpropanolamine (PPA) is widely used as a nasal decongestant administered orally in sustained release preparations and, in Sweden, the recommended dose nowadays is 50 mg twice daily for adults. The aim of this placebo-controlled, cross-over study was to determine the onset and duration of the decongestive effect of 50 and 100 mg PPA in 15 healthy subjects. All subjects arrived at the laboratory at 07.30 h. After an acclimatisation, the nasal mucosal baseline was established with rhinostereometry and the minimal cross-sectional area was measured using acoustic rhinometry. The systolic and diastolic blood pressures were also determined. Then all subjects were given their study drugs for the day and the measurements were repeated every hour for 8 h. This procedure was repeated for 3 days at 48 h intervals between the days. For purposes of comparison, the decongestive effect of oxymetazoline nasal spray was studied on a separate day. The decongestive effect of 100 mg PPA was similar to that of topical oxymetazoline. It develops after 1 h and lasts for approximately 6 h. The decongestive effect of oxymetazoline was significantly greater than that of 50 mg PPA and that of 100 mg PPA was significantly greater than that of 50 mg PPA using rhinostereometry, but not when using acoustic rhinometry. However, 50 mg PPA had no significant decongestive effect, compared with placebo, with rhinostereometry or acoustic rhinometry. In the first 3 h after administration of PPA, there was a dose-response increase in the systolic and diastolic blood pressures, which then returned to baseline. In conclusion, this study shows that PPA in double the recommended dose, i.e. 100 mg, has a significant decongestive effect on the nasal mucosa in healthy subjects. However, when the dose of PPA is increased the systolic and diastolic blood pressures also increase.
      pubtype: Academic Journal
      doctype:
        clinical trial
        research
        Journal Article
      ougenre: Article
    language: English
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