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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-GB-11-12-003243 | Other Identifier | MHRA |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PNS | Experimental | 2 sprays of experimental nasal spray per nostril 4 times per day for 7 days |
|
| SNS | Sham Comparator | 2 sprays of sham nasal spray per nostril 4 times per day for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymeric Nasal Spray | Device | Experimental nasal spray |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Kruse, PhD | McNeil AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synexus Thames Valley | Reading | Berkshire | RG2 0TG | United Kingdom | ||
| Synexus Wales |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| Sham Nasal Spray | Device | Sham nasal spray |
|
|
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 |
| Cardiff |
| Llaishen |
| CF14 5GJ |
| United Kingdom |
| Common Cold Center and Healthcare Clinical Trials | Cardiff | Wales | CF10 3AX | United Kingdom |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |