Primary Objective: * Explore association between nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infectionSecondary Objectives: * Explore the potential of the HRV-16 challenge model to produce covariates of…
ID
Source
Brief title
Condition
- Respiratory tract infections
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
* Erythema of the nasolabial area
* Nose soreness
* Common cold symptoms
* Biomarkers of inflammation and skin barrier function
Background summary
Diminished skin barrier function can predispose skin to inflammatory events.
Irritation of nasolabial skin and reduced skin barrier function occurs during
common cold episodes. Microbiota composition and shifts in composition that
occur in the nasal cavity during a common cold episode may affect the
composition of nasal secretions. This may, directly, or via the route of
modulating local microbiota composition on the nasolabial skin, affect the
susceptibility of individuals to irritation and inflammation of the nasolabial
skin. This pilot study will utilize the experimental rhinovirus infection model
to study changes in skin microbiota in relation to skin erythema and soreness.
Study objective
Primary Objective:
* Explore association between nasal microbiota composition and occurrence of
nose redness and soreness during rhinovirus infection
Secondary Objectives:
* Explore the potential of the HRV-16 challenge model to produce covariates of
nasolabial redness and soreness associated with common cold.
* Explore association between nasal microbiota composition obtained by nasal
wash (nasal cavity) and nasal swabs (anterior nares) and skin microbiota
obtained by nasolabial skin swabs, before and during rhinovirus infection
* Explore changes in biomarkers of inflammation and skin barrier function
during the course of a rhinovirus infection
* Explore association between biomarkers of inflammation and skin barrier
function and occurrence of nose redness and soreness during rhinovirus
infection
Study design
non-randomized pilot study of a nasal rhinovirus16 (RV16) challenge
Intervention
There are no (pharmacological or other) treatments being studied. This study
involves a nasal RV16 challenge in all subjects.
Study burden and risks
Study participants will have no direct benefit from participating. The main
burden for participants will be that they will suffer from a common cold
episode and will have to visit the AMC hospital seven times.
The RV16 infection protocol has often been used to challenge healthy
individuals, mild (allergic) asthmatics and COPD patients. The rationale for
using RV16 is that this rhinovirus strain causes mild common-cold symptoms as
compared to other rhinovirus strains. In addition, RV16 is considered to be not
very contagious. No adverse effects of using RV16 in healthy individuals and
patients have been reported.
Two small blood samples will be collected, one at the start and one at the end
of the study. A nasal lavage will be performed on 6 occasions; skin swabs will
be performed on 7 occasions during a visit, and 3 times by the participants
themselves, at home. Questionnaires have to be completed on 16 days during the
study. Participants will experience the physical discomfort associated with a
common cold episode. The health risks associated with participation are
considered to be minimal.
Winchester Rd 2100
NEENAH WI54956
US
Winchester Rd 2100
NEENAH WI54956
US
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60212.018.16 |