A Study of an Experimental Nasal Spray in Subjects With Early Signs of the Common Cold
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Symptoms of the Common Cold [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]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).
- Effect of Common Cold on Daily Activities [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]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).
- Effect of Common Cold Symptoms on Sleep [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]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).
- Number of Days Lost [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]The number of days lost at school or work because of the common cold will be recorded in the subject diary.
- Treatment Outcome [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2012|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
2 sprays of experimental nasal spray per nostril 4 times per day for 7 days
Device: Polymeric Nasal Spray
Experimental nasal spray
Other Name: Not yet marketed polymeric nasal spray
Sham Comparator: SNS
2 sprays of sham nasal spray per nostril 4 times per day for 7 days
Device: Sham Nasal Spray
Sham nasal spray
Other Name: Not marketed sham comparator
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.
|Synexus Thames Valley|
|Reading, Berkshire, United Kingdom, RG2 0TG|
|Cardiff, Llaishen, United Kingdom, CF14 5GJ|
|Common Cold Center and Healthcare Clinical Trials|
|Cardiff, Wales, United Kingdom, CF10 3AX|
|Study Director:||Elisabeth Kruse, PhD||McNeil AB|