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

NCT ID: NCT01488604

Last Updated: 2012-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-05-31

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.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PNS

2 sprays of experimental nasal spray per nostril 4 times per day for 7 days

Group Type: EXPERIMENTAL

Polymeric Nasal Spray

Intervention Type: DEVICE

Experimental nasal spray

SNS

2 sprays of sham nasal spray per nostril 4 times per day for 7 days

Group Type: SHAM_COMPARATOR

Sham Nasal Spray

Intervention Type: DEVICE

Sham nasal spray

Interventions

Polymeric Nasal Spray

Experimental nasal spray

Intervention Type: DEVICE

Sham Nasal Spray

Sham nasal spray

Intervention Type: DEVICE

Other Intervention Names

Not yet marketed polymeric nasal spray; Not marketed sham comparator

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McNeil AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth Kruse, PhD

Role: STUDY_DIRECTOR

McNeil AB

Locations

Synexus Thames Valley

Reading, Berkshire, United Kingdom

Synexus Wales

Cardiff, Llaishen, United Kingdom

Common Cold Center and Healthcare Clinical Trials

Cardiff, Wales, United Kingdom

Countries

United Kingdom

Other Identifiers

CIV-GB-11-12-003243

Identifier Type: OTHER

Identifier Source: secondary_id

POCEXP0003

Identifier Type: -

Identifier Source: org_study_id