Status:

COMPLETED

Experimental Human Rhinovirus Infection

Lead Sponsor:

Radboud University Medical Center

Conditions:

Common Cold

Eligibility:

All Genders

18-35 years

Phase:

PHASE1

Brief Summary

Our primary objective is to set up the Human Rhinovirus (HRV)-model in our centre. In addition, to facilitate future clinical trials, we want to determine optimal read-out parameters and read-out time...

Detailed Description

The importance of the common cold derives primarily from its frequency and from its enormous socioeconomic impact. Human Rhinoviruses (HRVs) are the major cause of the common cold, being responsible f...

Eligibility Criteria

Inclusion

  • Age ≥18 and ≤35 years of age
  • Healthy
  • Use of contraceptives (for female subjects only)

Exclusion

  • 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).

Key Trial Info

Start Date :

March 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2014

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT01823640

Start Date

March 1 2013

End Date

June 1 2014

Last Update

October 15 2014

Active Locations (1)

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1

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands, 6525 HB