CompletedPhase 3ACTRN12606000482561

Ipratropium, Oxymetazoline or Pseudoephedrine in Coryza

Double-blind placebo-controlled trial of on-demand topical oxymetazoline and ipratropium compared to oral pseudoephedrine in coryza


Sponsor

Cold Study Unit, Royal Adelaide Hospital

Enrollment

144 participants

Start Date

May 1, 2004

Study Type

Interventional

Conditions

Summary

The primary aim was to determine whether on demand topical oxymetazoline or regular oral pseudoephedrine is more effective at relieving congestion over 48 hours in acute coryza. A secondary aim was to determine whether on demand topical ipratropium is more effective than placebo in relieving nasal secretions over 48 hours in acute coryza. 144 normal subjects currently suffering from the common cold participated in a randomised, double-blind, triple-placebo controlled study of ipratropium, oxymetazoline or pseudoephedrine or combination ipratropium – oxymetazoline or ipratropium - pseudoephedrine in coryza. The subjects attended the Cold Study Unit for 2 visits, 48 hours apart. They were required to take oral pseudoephedrine or matching placebo, four times daily for 2 days. Oxymetazoline and ipratropium sprays where to be used on an as required basis. Subjective symptoms of congestion and runniness were measured daily on the Cold Study Unit Cold Symptom Questionnaire and on a visual analogue scale when attending for visits.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at: Ipratropium, Oxymetazoline or Pseudoephedrine in Coryza. It is open to Both males and females, aged 18 to 60. There are also some health conditions and factors that may prevent you from joining.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Ipratropium 42 mcg/spray, 2 sprays each nostril prn, maximum QID; Oxymetazoline 50 mcg/spray, 2 sprays each nostril prn, maximum QID; Pseudoephedrine 60 mg tablet QID; or matching placebos. Treatmen

Ipratropium 42 mcg/spray, 2 sprays each nostril prn, maximum QID; Oxymetazoline 50 mcg/spray, 2 sprays each nostril prn, maximum QID; Pseudoephedrine 60 mg tablet QID; or matching placebos. Treatment duration was 48hrs. Group 1: Active Ipratropium, Placebo Oxymetazoline and Pseudoephedrine. Group 2: Active Oxymetazoline, Placebo Ipratropium and Pseudoephedrine. Group 3: Active Pseudoephedrine, Placebo Ipratropium and Oxymetazoline. Group 4: Placebo Ipratropium, Oxymetazoline and Pseudoephedrine Group 5: Active Ipratropium and Oxymetazoline, Placebo Pseudoephedrine. Group 6: Active Ipratropium and Pseudoephedrine, Placebo Oxymetazoline.


Locations(1)

New Zealand

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ACTRN12606000482561