Common Cold
Conditions
Keywords
cold, common, rhinovirus
Brief summary
The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a virus that causes many common colds.
Detailed description
Rhinovirus infections are the most frequent cause up to 80% of cold illnesses during the fall rhinovirus season. While viral upper respiratory infections are generally mild and self-limited, they are associated with an enormous economic burden both in lost productivity and in expenditures for treatment. Rhinovirus infection is frequently associated with medical complications that have substantial morbidity such as acute otitis media and exacerbation of asthma. Marketed treatment options for rhinovirus consist primarily of symptomatic cold remedies have only modest effects on specific cold symptoms. 3804-250A is under investigation for the prevention of rhinovirus infection by interruption of person-to-person transmission appears to be technologically and economically feasible. The study is a randomized, double-blind, Placebo controlled, multi-site, parallel design clinical trial conducted in the natural setting. The study will be conducted during a 10-week period during the fall rhinovirus epidemic season. Healthy, normal subjects will be recruited and randomly assigned to the AV Lotion or Placebo control group. Subjects will use the assigned test product on a defined schedule and will record the presence of cold illness symptoms daily. Subjects will return to the study site every week during the study for review and clarification of study diary entries, for review and assessment of compliance, for specimen collection for rhinovirus PCR.
Interventions
DRUG3804-250A
* topical product * apply 2 pumps * apply at least every 4 hours or after hand washing
DRUG3804-291
* topical * apply 2 pumps * apply at least every 4 hours or after hand washing
Sponsors
Hill Top Research
TKL Research, Inc.
The Dial Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy normal * good general health
Exclusion criteria
* pregnancy * insulin dependent diabetes * daily smoker * skin disease on the hands/wrists * immunological disorders * occupation involving frequent handwashing * common cold symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. | 10 weeks | Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rhinovirus Infections. | 10 weeks | The incidence of rhinovirus infections |
| Rhinovirus-associated Colds | 10 weeks | The incidence of rhinovirus-associated cold illnesses. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Modified AV Lotion without active ingredients. | 206 |
| 3804-250A Experimental AV Lotion | 205 |
| Total | 411 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 1 |
| Overall Study | antibiotic use | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | non-compliance with study visits | 0 | 2 |
| Overall Study | Physician Decision | 2 | 14 |
| Overall Study | Protocol Violation | 5 | 6 |
| Overall Study | Seasonal allergies | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 12 |
Baseline characteristics
| Characteristic | Total | Placebo | 3804-250A |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 403 Participants | 203 Participants | 200 Participants |
| Age Continuous | 36.7 years STANDARD_DEVIATION 14.39 | 37.3 years STANDARD_DEVIATION 14.56 | 36.2 years STANDARD_DEVIATION 14.23 |
| Region of Enrollment United States | 411 participants | 206 participants | 205 participants |
| Sex: Female, Male Female | 305 Participants | 150 Participants | 155 Participants |
| Sex: Female, Male Male | 106 Participants | 56 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 206 | 16 / 205 |
| serious Total, serious adverse events | 2 / 206 | 0 / 205 |
Outcome results
Primary
The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.
Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group
Time frame: 10 weeks
Population: All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. | 47.1 cold illnesses per 100 subjects |
| 3804-250A | The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. | 43.9 cold illnesses per 100 subjects |
p-value: >0.5Poisson regression
Secondary
Rhinovirus-associated Colds
The incidence of rhinovirus-associated cold illnesses.
Time frame: 10 weeks
Population: All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Rhinovirus-associated Colds | 24.3 RV-associated cold illnesses per 100 sub |
| 3804-250A | Rhinovirus-associated Colds | 20.0 RV-associated cold illnesses per 100 sub |
p-value: 0.3451Poisson regression
Secondary
Rhinovirus Infections.
The incidence of rhinovirus infections
Time frame: 10 weeks
Population: All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Rhinovirus Infections. | 58.7 rhinovirus infections per 100 subjects |
| 3804-250A | Rhinovirus Infections. | 59.0 rhinovirus infections per 100 subjects |
p-value: >0.5Poisson regression