Upper Respiratory InfectionsPhase 4NCT02225912
A Study to Evaluate the Efficacy of the Nasal Antiseptic, PrevinC, When Administered for the RiskReduction of Rhinitis in Subjects Who Work for Child Day Care Centers
A Phase 4 study testing PrevinC in people with Upper Respiratory Infections, run by BioHealth Technologies Inc. at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Respiratory Infections
- What is being tested?
- PrevinC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- Feb 2005to May 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Sunflower Preschool & Day Care
Hialeah, Florida, 33010
Sunflower Preschool Childcare
Miami, Florida, 33125
Sunflowers Academy
Miami, Florida, 33125
Sunflowers Academy
Miami, Florida, 33135
Sunflowers Preschool Childcare
Miami, Florida, 33135
Mt Sinai Day Care
Miami Beach, Florida, 33141
About this study
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.
- Conditions
- Upper Respiratory Infections
- Being tested
- PrevinC, placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevinCOther
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| PrevinC | Experimental | PrevinC contains isopropyl alcohol, sesame oil, aloe vera oil extract, and lemon oil. Receives: 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinitis
The incidence of rhinitis was measured on a weekly basis through evaluation of study diaries.
Measured: weekly from February 2005 to May 2005, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startFeb 2005
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- BioHealth Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225912
- Sponsor's protocol ID
- Previn-C
- Status last verified
- Aug 2014
- First submitted
- 23 Aug 2014
- Last updated
- 16 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of the Nasal Antiseptic, PrevinC, When Administered for the RiskReduction of Rhinitis in Subjects Who Work for Child Day Care Centers
- ClinicalTrials.gov ID
- NCT02225912
- Acronym / sponsor ID
- Previn-C
- Conditions
- Upper Respiratory Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- BioHealth Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrevinC | Experimental | Other: PrevinCPrevinC contains isopropyl alcohol, sesame oil, aloe vera oil extract, and lemon oil. |
| Control solution | Placebo comparator | Drug: placeboThe control solution (distilled water and lemon oil) was similar in color, oily consistency and odor to that of PrevinC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrevinC | Other | PrevinC |
| placebo | Drug | Control solution |
Primary outcome
Rhinitis
Time frame: weekly from February 2005 to May 2005, up to 3 months
The incidence of rhinitis was measured on a weekly basis through evaluation of study diaries.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PrevinC in people with Upper Respiratory Infections, run by BioHealth Technologies Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinitis (time frame: weekly from February 2005 to May 2005, up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.