NCT02225912

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
Last Updated

January 16, 2019

Status Verified

August 1, 2014

Enrollment Period

3 months

First QC Date

August 23, 2014

Last Update Submit

January 15, 2019

Conditions

Upper Respiratory Infections

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

PrevinC

EXPERIMENTAL

PrevinC contains isopropyl alcohol, sesame oil, aloe vera oil extract, and lemon oil.

Other: PrevinC

Control solution

PLACEBO COMPARATOR

The control solution (distilled water and lemon oil) was similar in color, oily consistency and odor to that of PrevinC.

Drug: placebo

Interventions

PrevinCOTHER
PrevinC
placeboDRUG
Control solution

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must provide written informed consent prior to the conduct of any study
  • Male or female
  • years of age
  • Inclusive
  • Employed by one of seven selected Day Care Centers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sunflower Preschool & Day Care

Hialeah, Florida, 33010, United States

Location

Sunflower Preschool Childcare

Miami, Florida, 33125, United States

Location

Sunflowers Academy

Miami, Florida, 33125, United States

Location

Sunflowers Academy

Miami, Florida, 33135, United States

Location

Sunflowers Preschool Childcare

Miami, Florida, 33135, United States

Location

Mt Sinai Day Care

Miami Beach, Florida, 33141, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 4
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2014

First Posted

August 26, 2014

Study Start

February 1, 2005

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

January 16, 2019

Record last verified: 2014-08

Locations

US(6)