A Study of an Experimental Nasal Spray in Subjects With Early Signs of the Common Cold

Study Overview
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Brief Summary
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This study will test 200 people to see if an experimental nasal spray has an effect on symptoms of the common cold if used when the symptoms start. At the first visit to the clinic, potential subjects will have tests to make sure they qualify to participate in the study. If they qualify, they will have an equal chance of receiving the experimental nasal spray or a sham nasal spray (one that does not have the experimental formula). At the first visit, subjects will receive their assigned nasal spray and use it once at the clinic. They will also receive a booklet called a diary. Subjects will take the rest of their treatments for day 1 at home, and for the next six days, they will use the nasal spray four times per day and record their symptoms in the diary, as instructed. Then subjects will come back to the clinic for a final visit.

Detailed Description
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This is an investigation in healthy subjects with early signs of common cold. Subjects will be randomly assigned in a 1:1 ratio to receive either Polymeric Nasal Spray or a matching placebo nasal spray. Subjects will be screened for eligibility and randomized to treatment at the Screening/ Randomization Visit (Day 1). Subjects will apply the first dose of the nasal spray at this visit under supervision. The other applications will take place at home on Day 1. On Days 2 through 7, subjects will use their assigned nasal spray as 2 sprays per nostril, 4 times per day. One Follow up Visit will be conducted within 3 days of the last application of nasal spray. Enrollment will continue until 200 subjects have completed the investigation (100 per treatment group). The subject and the investigative staff will be blinded to the assigned nasal spray. Efficacy will be measured, and recorded in the subject's diary, and safety will be assessed by reported AEs and ADEs.

Official Title
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Efficacy and Safety of an Antiviral Polymeric Nasal Spray: A Randomized, Parallel Group, Double-blind, Placebo-controlled Study in Subjects With Early Symptoms of Common Cold

Conditions
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Common Cold

Intervention / Treatment
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* Device: Polymeric Nasal Spray
* Device: Sham Nasal Spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have early signs of a common cold: If female of child-bearing potential, have a negative pregnancy test at Screening. Have signed and dated the informed consent document, indicating that they have been informed of all pertinent aspects of the investigation Are willing and able to comply with scheduled visits, treatment plan, and other investigation procedures Exclusion Criteria: Have had common cold or flu-like symptoms outside the protocol-specified parameters. Are current smokers as defined by the protocol. Have any medical history or condition or use any drug or device that (per protocol or in the opinion of the investigator) might compromise subject safety, participation in the trial, action of the investigational device, or results of the investigation.. Are related to anyone involved with the conduct of the investigation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PNS<br>2 sprays of experimental nasal spray per nostril 4 times per day for 7 days | Device: Polymeric Nasal Spray<br>* Experimental nasal spray<br>* Other names: Not yet marketed polymeric nasal spray;|
| Sham Comparator: SNS<br>2 sprays of sham nasal spray per nostril 4 times per day for 7 days | Device: Sham Nasal Spray<br>* Sham nasal spray<br>* Other names: Not marketed sham comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of the Common Cold | Subjects will score their symptoms of the common cold including local symptoms (sore throat, blocked nose, runny nose, cough, and sneezing) and systemic symptoms (headache, muscle ache, and chilliness) on a scale of 0-3, where 0=: None (symptoms not present in the previous 24 hours) and 3= Severe (symptoms disturbing/irritating most of the time). | Within 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Common Cold on Daily Activities | Subjects will score how their cold affects daily activities on a scale of 0-3, where 0= None (able to carry out daily activities as normal) and 3= Severe (very limited or no ability to carry out daily activities). | Within 7 days | 
| Effect of Common Cold Symptoms on Sleep | Subjects will score how their cold affects ability to sleep on a scale of 0-3, where 0= None (no effect on sleep) and 3= Severe (sleep severely affected, or sleep not possible). | Within 7 days | 
| Number of Days Lost | The number of days lost at school or work because of the common cold will be recorded in the subject diary. | Within 7 days | 
| Treatment Outcome | Treatment outcome will be recorded by the subject on the evenings of treatment days on a scale of 0-4, where 0=Complete recovery and 4=Deterioration. | Within 7 days |