RUDOLPH Study; Changes in nasal microbiota and concurrent nose soreness associated with common cold infection * a pilot using the HRV-16 challenge model in healthy subjects

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Healthy men or women
- Age *18 and *50 years of age
- Self reported proneness to developing symptoms of nose redness and/or soreness.
- Fitzpatrick skintypes I, II or III
- Sero-negative (< 1:6) to HRV-16 at screening (shortly before inclusion)
- Willing to adhere to the study procedures

Exclusion Criteria

- Pregnancy or lactating
- History of pre-existent lung disease, including asthma
- Confirmed or self-reported allergic rhinitis
- Use of anti-inflammatory medication (i.e. nasal steroids and topical steroids in the nasolabial area) or medication targeted at treatment of nose and/or lung problems. NSAIDS like ibuprophen, etc, are acceptable
- Use of antibiotics (oral/topical, within 3 months prior to the start of the trial)
- Use of anti-histamines or other non-prescription cold medicines
- Use of alcohol > 5/day or >20/wk
- Use of any drugs
- Current smoker, or smoked in past 12 months, or more than 5 pack-year history. Smoking includes cigars, marijuana and electronic cigarettes
- More than 3 nosebleeds per month
- History of nasal or otologic surgery
- Febrile illness or a common cold within six weeks before the HRV challenge
- Presence of atopic dermatitis, rosacea, psoriasis, and/or eczema on or near the nose.
- Recent surgery within the past 3 months
- Immunocompromised condition or chronic disease the investigator feels is significant
- Frequent contact with elderly or children under the age of 2 years during the course of the trial
- Currently participating in another clinical trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The microbiota composition of the nasal cavity, anterior nares and nasolabial<br /><br>skin, and shifts in composition during the course of experimental RV16<br /><br>infection in subjects with occurrence of nasolabial erythema and nose soreness </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Erythema of the nasolabial area<br /><br>* Nose soreness<br /><br>* Common cold symptoms<br /><br>* Biomarkers of inflammation and skin barrier function</p><br>