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

December 6, 2011
May 8, 2012
January 2012
May 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01488604 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Study of an Experimental Nasal Spray in Subjects With Early Signs of the Common Cold
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Common Cold
  • Device: Polymeric Nasal Spray
    Experimental nasal spray
    Other Name: Not yet marketed polymeric nasal spray
  • Device: Sham Nasal Spray
    Sham nasal spray
    Other Name: Not marketed sham comparator
  • Experimental: PNS
    2 sprays of experimental nasal spray per nostril 4 times per day for 7 days
    Intervention: Device: Polymeric Nasal Spray
  • Sham Comparator: SNS
    2 sprays of sham nasal spray per nostril 4 times per day for 7 days
    Intervention: Device: Sham Nasal Spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01488604
POCEXP0003, CIV-GB-11-12-003243
No
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
McNeil AB
Not Provided
Study Director: Elisabeth Kruse, PhD McNeil AB
Johnson & Johnson Consumer and Personal Products Worldwide
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP