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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02225912
Other study ID # Previn-C
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 2005
Est. completion date May 2005

Study information

Verified date August 2014
Source BioHealth Technologies Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The hypothesis was to establish whether the use of PrevinC administered nasally 2-3 times a day will prevent upper respiratory infections in otherwise healthy adults working in child day care centers.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Subject must provide written informed consent prior to the conduct of any study

- Male or female

- 18-65 years of age

- Inclusive

- Employed by one of seven selected Day Care Centers

Exclusion Criteria:

- Recent symptoms of upper respiratory infection, respiratory disease

- Received medication for colds or allergies within 3 weeks of enrolling

- Had nasal surgery within 2 months of enrolling

- Had a pierced nose or wore nose jewelry

Study Design


Intervention

Other:
PrevinC

Drug:
placebo


Locations

Country Name City State
United States Sunflower Preschool & Day Care Hialeah Florida
United States Sunflower Preschool Childcare Miami Florida
United States Sunflowers Academy Miami Florida
United States Sunflowers Academy Miami Florida
United States Sunflowers Preschool Childcare Miami Florida
United States Mt Sinai Day Care Miami Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
BioHealth Technologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rhinitis The incidence of rhinitis was measured on a weekly basis through evaluation of study diaries. weekly from February 2005 to May 2005, up to 3 months
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