Clinical trial NCT01488604: A Study of an Experimental Nasal Spray in Subjects With Early Signs of the Common Cold
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2011-12-08
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Symptoms of the Common Cold
timeFrame: Within 7 days
Secondary outcomes:
measure: Effect of Common Cold on Daily Activities
timeFrame: Within 7 days
measure: Effect of Common Cold Symptoms on Sleep
timeFrame: Within 7 days
measure: Number of Days Lost
timeFrame: Within 7 days
measure: Treatment Outcome
timeFrame: Within 7 days
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Synexus Thames Valley
state: Berkshire
city: Cardiff
country: United Kingdom
facility: Synexus Wales
state: Llaishen
city: Cardiff
country: United Kingdom
facility: Common Cold Center and Healthcare Clinical Trials
state: Wales
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References: