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; 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45430

Enrollment

Registered

2017-02-01

Start date

2017-03-09

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

nasolabial erythema associated with common cold

Interventions

There are no (pharmacological or other) treatments being studied. This study involves a nasal RV16 challenge in all subjects.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 (

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The microbiota composition of the nasal cavity, anterior nares and nasolabial skin, and shifts in composition during the course of experimental RV16 infection in subjects with occurrence of nasolabial erythema and nose soreness	—

Secondary

Measure	Time frame
* Erythema of the nasolabial area * Nose soreness * Common cold symptoms * Biomarkers of inflammation and skin barrier function	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)