Upper Respiratory Infections Clinical Trial
| 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 |
| Verified date | August 2014 |
| Source | BioHealth Technologies Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| BioHealth Technologies Inc. |
United States,
| 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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