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 - RUDOLPH Study

Kimberly-Clark Corporation0 sites10 target enrollmentStarted: TBDLast updated: April 15, 2024

Conditions

Trial Snapshot

No summary available.

•- 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

•- 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

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