Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000482561
Ethics application status
Approved
Date submitted
20/11/2006
Date registered
23/11/2006
Date last updated
23/11/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ipratropium, Oxymetazoline or Pseudoephedrine in Coryza
Scientific title
Double-blind placebo-controlled trial of on-demand topical oxymetazoline and ipratropium compared to oral pseudoephedrine in coryza
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coryza (Common Cold) 1459 0
Condition category
Condition code
Respiratory 1555 1555 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1453 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 2148 0
To determine whether as needed topical Oxymetazoline or regular oral Pseudoephedrine is more effective at relieving congestion over 48 hours in acute coryza.
Timepoint [1] 2148 0
Subjective levels of congestion will be measured at Visit 1 and at Visit 2 (48 hours later) and between visits using the Cold Study Unit Cold Symptom Questionnaire.
Secondary outcome [1] 3729 0
1. Determine whether as needed topical ipratroprium is more effective than placebo in relieving nasal secretions over 48 hours in acute coryza.
Timepoint [1] 3729 0
Subjective levels of rhinorrhea (runny nose) will be measured at Visit 1 and at Visit 2 (48hours later) and between visits using the Cold Study Unit Cold Symptom Questionnaire.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers - undertaken by the Pharmacy Department, Royal Adelaide Hospital
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using randomisation table from a statistics book - undertaken by the Pharmacy Department, Royal Adelaide Hospital
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Due to difficulties in sourcing a matching placebo, the Ipratropium placebo did not match the Ipratropium active, so this arm only was open. All Cold Study Unit staff and subjects were blind to the decongestant arms (primary outcome) of the study. Staff were unblinded to the ipratropium arm at the visits, but subjects were not explicitly made aware of the differing appearances of the bottles. Data analysis was done blinded.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment outside Australia
Country [1] 420 0
New Zealand
State/province [1] 420 0

Funding & Sponsors
Funding source category [1] 1696 0
Hospital
Name [1] 1696 0
Cold Study Unit, Royal Adelaide Hospital
Country [1] 1696 0
Australia
Primary sponsor type
Hospital
Name
Cold Study Unit, Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 1496 0
None
Name [1] 1496 0
None
Address [1] 1496 0
Country [1] 1496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3147 0
Cold Study Unit, Royal Adelaide Hospital
Ethics committee address [1] 3147 0
Ethics committee country [1] 3147 0
Australia
Date submitted for ethics approval [1] 3147 0
Approval date [1] 3147 0
25/06/2004
Ethics approval number [1] 3147 0
040518

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27387 0
Address 27387 0
Country 27387 0
Phone 27387 0
Fax 27387 0
Email 27387 0
Contact person for public queries
Name 10642 0
Jenny Latte
Address 10642 0
Cold Study Unit
S4 North Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 10642 0
Australia
Phone 10642 0
+61 8 82222955
Fax 10642 0
+61 8 82224661
Email 10642 0
[email protected]
Contact person for scientific queries
Name 1570 0
Dr David Taverner
Address 1570 0
Cold Study Unit
S4 North Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 1570 0
Australia
Phone 1570 0
+61 8 8222 4661
Fax 1570 0
+61 8 82224661
Email 1570 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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