Experimental Human Rhinovirus Infection, a randomized placebo-controlled pilot study

Completed

• Conditions: common cold; Rhinovirus infection; 10047438

• Registration Number: NL-OMON37030
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Written informed consent
- Age >=18 and <=35
- Healthy
- Use of contraceptives (for female subjects only)

Exclusion Criteria

- Pregnancy or lactating
- Pre-existent lung disease, including asthma
- A history of allergic rhinitis with positive allergen skin tests
- Use of any medication
- Use of alcohol > 5/day or >20/wk
- Use of any drugs
- Current smoker or more than 5 pack-year history
- Frequently have nosebleeds
- Recent nasal or otologic surgery
- Febrile illness or a common cold within four weeks before the HRV challenge
- Currently participating in another clinical trial
- Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, acid burn inhibitors or immune suppressive agents (up till 3 months prior to inclusion), and pre- and probiotics (up till 1 month prior to inclusion).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the infection rate (defined by a positive viral<br /><br>culture, qPCR and/or a four-fold rise in antibody titre) of healthy<br /><br>volunteers inoculated with a standardized dose of HRV-16.</p><br>