None listed
Conditions
Brief 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.
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. 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
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.
Sponsors
Cold Study Unit, Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who provide written informed consent at Visit 1 prior to any procedures being conducted. 2. Subjects who have symptoms of acute coryza, which started no earlier than 48 hours prior to Visit 1. 3. Subjects who report their nasal congestion at least as ‘moderate’ (0-no congestion, 1-mild congestion, 2-moderate congestion, 3-moderate-severe congestion, 4-severe congestion) andat least a mild rhinorrhea and/or a mild sore throat in the 48hrs prior to study ORSubjects who report their rhinorrhea at least as ‘moderate’ (0-no rhinorrhea, 1-mild rhinorrhea, 2-moderate rhinorrhea, 3-moderate-severe rhinorrhea, 4-severe rhinorrhea) andmild nasal congestion and/or a mild sore throat in the 48hrs prior to study 4. A female subject of child bearing potential must be using a medically acceptable method of birth control for at least one month prior to Visit 1 (i.e., abstinence, birth control pills, Intrauterine Device (IUD), Depo-Provera®, or condoms), and willing to undergo a urine pregnancy test.If she is at least one year postmenopausal, she will be eligible without using birth control. 5. Subjects who complete all specified medication/therapy washouts. 6. Subjects willing and able to comply with the requirements of the study; most particularly adherence to the study medication dosing requirements, medication/therapy prohibitions, visit schedule, willing to complete diary and questionnaire.
Exclusion criteria
1. Subjects who have obstructive nasal polyps or significant nasal tract structural malformations (eg deviated septum)2. Subjects with a bacterial sinusitis infection during the past 2 weeks prior to study entry.3. Subjects with a history of significant allergic or perennial rhinitis (defined as congested/runny nose for more than 2 continuous weeks in the previous 12 months).4. Subjects with a known hypersensitivity to or idiosyncratic reaction to Ipratropium (IB), Oxymetazoline (Oxy) or Pseudoephedrine (PSE).5. Subjects taking drugs that may interfere with nasal function within a specific period of the study.6. Subjects who have used antibiotics (all forms) within the past 1 week, except for tetracyclines for acne.7. Subjects using tricyclic antidepressant drugs or monoamine oxidase inhibitors8. Subjects with a history of: (a) renal failure or impairment, hepatic cirrhosis, or gut disease likely to alter drug kinetics, (b) known ischaemic heart disease, angina or cardiac arrhythmias, (c) hypothyroidism or hyperthyroidism, (d) diabetes, (e) other significant medical illness likely in the opinion of the clinical investigator to influence the response to treatment.9. Subjects who have other significant respiratory disease that requires any use of assisted ventilation, or Continuous Positive Airway Pressure (CPAP).10. Current smokers (defined as those who smoke more than 25 cigarettes per day).11. Women who are pregnant or nursing, or women capable of childbearing and not using a medically acceptable method of birth control for at least one month prior to Visit 1, who have had unprotected sex in the last month.12. Subjects with a history of glaucoma or raised intra-occular pressure and/or taking medication for such conditions.13. Any male subjects with a history of benign prostatic hypertrophy (BPH).14. Subjects who have participated in a trial of an investigational drug within 30 days or an investigational steroid drug within 90 days of enrollment in this study.15. Subjects with a screening blood pressure > 150/95 mmHg, or a diagnosis of arterial hypertension and/or taking medication for hypertension.16. Subjects, who have, in the judgement of the investigator, any clinically abnormal vital sign that is (a) not due to a known underlying disease and considered by the investigator to contraindicate study participation, or (b) clinically significant, based on clinical evaluation and/or other tests.17. Subjects who have previously participated in this protocol.18. Subjects considered unsuitable for entry into the study by the Investigator.
Outcome results
None listed