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Trial registered on ANZCTR


Registration number
ACTRN12606000484549
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
Nasal IL-8 Correlation With Virus Isolation And Symptoms In Natural Coryza - A Pilot Study
Scientific title
Nasal IL-8 Correlation With Virus Isolation And Symptoms In Natural Coryza - A Pilot Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coryza (Common Cold) 1461 0
Condition category
Condition code
Respiratory 1557 1557 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None - as this was an observational study.
Subjects with the common cold were seen at 2 visits 14 days appart. Objective measures of the commom cold included; at Visit 1 a nasal aspirate for virus culturing; At Visits 1 and 2 nasal lavage was performed to collect samples for the IL-8 assay, At Visits 1 and 2 Acoustic rhinometry was performed to mearse Nasal Volume (NVol) and Minimum Cross-sectional Area (MCA). Subjective symptoms of the common cold were collected at both visits and on a daily basis between visits, with subjects completing the Cold Study Unit Cold Symptom Questionnaire (CSUCSQ).
Intervention code [1] 1455 0
None
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 2151 0
Is nasal IL-8 secretion a marker of cold virus isolation?
Timepoint [1] 2151 0
At Visit 1 a nasal aspirate was performed to collect a sample for virus culturing. Nasal secreations were collected at Visit 1 and 2 (14 days apart) and these samples were assayed for IL-8.
Secondary outcome [1] 3734 0
1. Is the severity of common cold symptoms predicted by nasal IL-8 secretion.
Timepoint [1] 3734 0
Subjective symptoms of the common cold collected at visits 1 and 2 from the CSUCSQ were compared with IL-8 levels at each visit.
Secondary outcome [2] 3735 0
2. Is the severity of objective coryza findings predicted by nasal IL-8 secretion
Timepoint [2] 3735 0
Acoustic rhinometry measures of NVol and MCA at visits 1 and 2 were compared with IL-8 levels at each visit.

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 48hours prior to the trial 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). 4. Subjects who report having had at least a mild sore throat in the 48hrs prior to study visit and/or a mild runny nose in the 48 hours prior to the study visit. 5. Subjects willing and able to comply with the requirements of the study.
Minimum age
18 Years
Maximum age
65 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 taking drugs that may interfere with nasal function within a specific period of the study (Appendix B).5. Subjects who have used antibiotics (all forms) within the past 1 week, except for tetracyclines for acne.6. Subjects who have other significant respiratory disease that requires any use of assisted ventilation, or Continuous Positive Airway Pressure (CPAP).7. Current smokers (defined as those who have smoked more than an average of 1 cigarette per day in the previous month).8. Pregnant women (pregnancy is associated with physiological nasal congestion), or women capable of childbearing and not on OCPs who have had unprotected sex in the last month.9. 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.10. 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.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/06/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 422 0
New Zealand
State/province [1] 422 0

Funding & Sponsors
Funding source category [1] 1698 0
Hospital
Name [1] 1698 0
Cold Study Unit, Royal Adelaide Hospital
Country [1] 1698 0
Australia
Primary sponsor type
Hospital
Name
Cold Study Unit, Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 1498 0
None
Name [1] 1498 0
None
Address [1] 1498 0
Country [1] 1498 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3150 0
Cold Study Unit, Royal Adelaide Hospital
Ethics committee address [1] 3150 0
Ethics committee country [1] 3150 0
Australia
Date submitted for ethics approval [1] 3150 0
Approval date [1] 3150 0
20/06/2003
Ethics approval number [1] 3150 0
030510B

Summary
Brief summary
It is likely that the host immune response causes at least some of the symptoms of coryza. Several cytokines influencing immune cell activity are implicated in the common cold including IL-8. A positive association between the level of IL-8 secretion and the severity of cold symptoms has been found previously.
There are no previous studies of IL-8 secretion and symptom severity in naturally acquired colds in adults, and this observational study was designed to investigate this.
Sixty subjects with symptoms of the common cold of less than 48 hours duration attended for two visits. At each visit subjective assessments, acoustic rhinometry and nasal lavage for IL-8 was performed. Virology samples were taken at Visit 1. This was an observational study of natural coryza and no randomisation or intervention occurred.
IL-8 concentrations were elevated at onset. There was a significant association between symptoms and IL-8 concentrations at onset (p=0.01).
These findings are consistent with the nasal cytokine response to virus infection causing the common cold syndrome. Symptoms in the common cold corresponds significantly with an objective measure of the host immune response.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27389 0
Address 27389 0
Country 27389 0
Phone 27389 0
Fax 27389 0
Email 27389 0
Contact person for public queries
Name 10644 0
Jenny Latte
Address 10644 0
Cold Study Unit
S4 North Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 10644 0
Australia
Phone 10644 0
+61 8 82222955
Fax 10644 0
+61 8 82224661
Email 10644 0
[email protected]
Contact person for scientific queries
Name 1572 0
Dr David Taverner
Address 1572 0
Cold Study Unit
S4 North Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 1572 0
Australia
Phone 1572 0
+61 8 8222 4661
Fax 1572 0
+61 8 82224661
Email 1572 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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