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Nasal IL-8 Correlation With Virus Isolation And Symptoms In Natural Coryza - A Pilot Study

Nasal IL-8 Correlation With Virus Isolation And Symptoms In Natural Coryza - A Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12606000484549
Enrollment
60
Registered
2006-11-23
Start date
2003-06-20
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 b

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).

Sponsors

Cold Study Unit, Royal Adelaide Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 65 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 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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026