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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01488604
First received: December 6, 2011
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Common Cold
Device: Polymeric Nasal Spray
Device: Sham Nasal Spray

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 163
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PNS
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488604

Locations
United Kingdom
Synexus Thames Valley
Reading, Berkshire, United Kingdom, RG2 0TG
Synexus Wales
Cardiff, Llaishen, United Kingdom, CF14 5GJ
Common Cold Center and Healthcare Clinical Trials
Cardiff, Wales, United Kingdom, CF10 3AX
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT01488604     History of Changes
Other Study ID Numbers: POCEXP0003, CIV-GB-11-12-003243
Study First Received: December 6, 2011
Last Updated: May 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014