Common ColdNCT01488604
A Study of an Experimental Nasal Spray in Subjects With Early Signs of the Common Cold
A study testing Polymeric Nasal Spray in people with Common Cold, run by McNeil AB at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Cold
- What is being tested?
- Polymeric Nasal Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jan 2012to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Synexus Wales
Cardiff, Llaishen, CF14 5GJ
Common Cold Center and Healthcare Clinical Trials
Cardiff, Wales, CF10 3AX
Synexus Thames Valley
Reading, Berkshire, RG2 0TG
About this study
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
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.
Read the 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
- Being tested
- Polymeric Nasal Spray, Sham Nasal Spray
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymeric Nasal SprayDevice
Also called Not yet marketed polymeric nasal spray
Experimental nasal spray
Sham Nasal SprayDevice
Also called Not marketed sham comparator
Sham nasal spray
| Study group | Role | What they receive |
|---|---|---|
| PNS | Experimental | 2 sprays of experimental nasal spray per nostril 4 times per day for 7 days Receives: Device: Polymeric Nasal Spray |
| SNS | Sham comparator | 2 sprays of sham nasal spray per nostril 4 times per day for 7 days Receives: Device: Sham Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 7 days
Secondary outcomes (4)
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).
Measured: Within 7 days
Effect of Common Cold Symptoms on Sleep
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).
Measured: 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.
Measured: 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.
Measured: Within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488604
- Sponsor's protocol ID
- POCEXP0003
- Other IDs
- CIV-GB-11-12-003243
- Status last verified
- May 2012
- First submitted
- 6 Dec 2011
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01488604
- Acronym / sponsor ID
- POCEXP0003
- Conditions
- Common Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNS | Experimental | Device: Polymeric Nasal Spray2 sprays of experimental nasal spray per nostril 4 times per day for 7 days |
| SNS | Sham comparator | Device: Sham Nasal Spray2 sprays of sham nasal spray per nostril 4 times per day for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymeric Nasal SprayAlso: Not yet marketed polymeric nasal sprayExperimental nasal spray | Device | PNS |
| Sham Nasal SprayAlso: Not marketed sham comparatorSham nasal spray | Device | SNS |
Primary outcome
Symptoms of the Common Cold
Time frame: Within 7 days
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).
4 secondary outcomes
Effect of Common Cold on Daily Activities
Time frame: Within 7 days
Effect of Common Cold Symptoms on Sleep
Time frame: Within 7 days
Number of Days Lost
Time frame: Within 7 days
Treatment Outcome
Time frame: Within 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Kruse, PhD study director
McNeil AB
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymeric Nasal Spray in people with Common Cold, run by McNeil AB at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of the Common Cold (time frame: Within 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2012; AzTrials last refreshed its copy on 6 Nov 2026.