Nasal CongestionPhase 2NCT02113449
Market Potential of Carbon Dioxide Nasal Spray
A Phase 2 study testing Carbon Dioxide in people with Nasal Congestion, run by GlaxoSmithKline at 4 sites in United States.
Trial summary
Carbon dioxide (CO2) is a naturally occurring gas that readily diffuses across body tissues and membranes. Data from earlier clinical studies conducted in 975 subjects with allergic rhinitis have shown that nasally administered CO2 may provide relief of the associated symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Congestion
- What is being tested?
- Carbon Dioxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2013to Feb 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant who demonstrate understanding of, and willingness to participate in the study
- Aged at least 18 years.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee
- Participant has perception of Nasal Breathing score ≤70 mm (Visual Analogue Scale) on the evaluation day
- Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
Who cannot join
- Women who are known to be pregnant or who have a positive pregnancy test, or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Recent history (within the last 2 years) of alcohol or other substance abuse.
- Medical history of significant respiratory impairment.
- No history of product purchase for treatment of nasal congestion
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Radiant Research - Chandler, AZ
Chandler, Arizona, 85224
Radiant Research - Cincinnati
Cincinnati, Ohio, 45249
TKL Research Inc
Paramus, New Jersey, 07652
Radiant Research - Pinellas Park, FL
Pinellas Park, Florida
About this study
Official title: A Study to Assess the Market Potential of a Carbon Dioxide Nasal Spray in Congested Subjects
Carbon dioxide (CO2) is a naturally occurring gas that readily diffuses across body tissues and membranes. Data from earlier clinical studies conducted in 975 subjects with allergic rhinitis have shown that nasally administered CO2 may provide relief of the associated symptoms. Symptom relief has been shown to occur as soon as 10 minutes after administration, and may persist for four to six hours.
This study aims to assess the consumer appeal of a prototype CO2 delivery device, as well as evaluate its perceived effectiveness for nasal congestion. Properly consented subjects who qualify and choose to participate in the clinical study will be administered nasal CO2 under medical supervision, wait a period of 1 hour in clinic, and then be dispensed a device for self-treatment at home. Subjects will return to the clinic on day 7 for final evaluation and completion of assessment questionnaires.
Read the detailed description
This study will be conducted in two parts. In the first part of the study, recruited subjects with nasal congestion will view a description of a new treatment option (concept). Interested subjects will be offered the opportunity to enter the clinical trial. Subjects who consent and are found otherwise eligible will then receive one dose of CO2 in the study clinic under medical supervision. Afterward, subjects who wish to continue will be allowed to take the administration device home for an additional six days of use (study part 2).
During the at-home use portion of the study, subjects will use a diary to record the number of times the product was used and their nasal congestion symptoms before and after use.
At the end of the study period, subjects will return to the study center for global assessment of their impressions of treatment and to answer questions designed to estimate market acceptability. Subjects may be asked to participate voluntarily in a market research focus group following their participation in this study.
- Conditions
- Nasal Congestion
- Being tested
- Carbon Dioxide
- Keywords
- Carbon Dioxide, Allergy symptoms
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon DioxideDrug
Nasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants will receive one dose of nasal carbon dioxide (CO2) in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day. Receives: Drug: Carbon Dioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Which One Product That Relieves Nasal Congestion do You Buy Most Often?
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked as part of screening survey prior to concept viewing. If the participant answered "I do not purchase any product to relieve congestion" the participant was excluded. Participants could select only one option available.
Measured: 7 days
Which of the Statements Best Describes the Extent to Which the Spray Reached Your Expectations?
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first use. Participants could select only one option.
Measured: 7 days
If the Product You Just Tried (After First Dose) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.
Measured: 7 days
Would You be Interested in Taking the Spray Product Home and Using it Over the Next Week?
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.
Measured: 7 days
Which of the Following Statements Best Describes the Extent to Which the Spray Reached Your Expectations?
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
Measured: 7 days
Divide 11 Points Between Two Products (CO2 Nasal Spray and Brand Selected at Q1)?
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option. It was done to compare the spray with the product selected by the participant in Q1. There were 11 points between the two products that participants could divide anyways thet wanted (11-0, 10-1, 9-2, 8-3, 7-4 or 6-5 etc). The more the participant liked a product compared to other, the higher the number of points were to be given to that product.
Measured: 7 days
If the Product You Just Tried (After At-home Use) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
Measured: 7 days
How Many Packages Would You Buy?
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience.This question was asked after at-home use of the product. Participants could select only one option.
Measured: 7 days
Which One Statement Best Describes How Often, if Ever, You Think You Would Buy the Spray Product in the Future?
There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
Measured: 7 days
How Often do You Think This Spray Product Would Last for You Personally?
There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
Measured: 7 days
Provide a Score From 1-7 to Some Statements, Depending on How Much You Think Each Statement Applies or Does Not Apply to the Spray Product That You Used
A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it. You can use any score from 1 to 7 to indicate how much or how little you think the statement applies to this product
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal CongestionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113449
- Sponsor's protocol ID
- 202181
- Other IDs
- RH01910
- Status last verified
- Apr 2015
- First submitted
- 6 Feb 2014
- Last updated
- 30 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Johnson SM, Hamilton AM, Lauersen LA. A phase IV, single-center, crossover evaluation of the efficacy of an external nasal dilator strip in children with nasal congestion. Allergy Asthma Proc. 2016 May;37(3):242-7. doi: 10.2500/aap.2016.37.3950.
PubMed 27178892
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Market Potential of a Carbon Dioxide Nasal Spray in Congested Subjects
- ClinicalTrials.gov ID
- NCT02113449
- Acronym / sponsor ID
- 202181
- Conditions
- Nasal Congestion
- Keywords
- Carbon Dioxide, Allergy symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Posted 7 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Carbon dioxide (CO2) is a naturally occurring gas that readily diffuses across body tissues and membranes. Data from earlier clinical studies conducted in 975 subjects with allergic rhinitis have shown that nasally administered CO2 may provide relief of the associated symptoms. Symptom relief has been shown to occur as soon as 10 minutes after administration, and may persist for four to six hours.
This study aims to assess the consumer appeal of a prototype CO2 delivery device, as well as evaluate its perceived effectiveness for nasal congestion. Properly consented subjects who qualify and choose to participate in the clinical study will be administered nasal CO2 under medical supervision, wait a period of 1 hour in clinic, and then be dispensed a device for self-treatment at home. Subjects will return to the clinic on day 7 for final evaluation and completion of assessment questionnaires.
Detailed description
This study will be conducted in two parts. In the first part of the study, recruited subjects with nasal congestion will view a description of a new treatment option (concept). Interested subjects will be offered the opportunity to enter the clinical trial. Subjects who consent and are found otherwise eligible will then receive one dose of CO2 in the study clinic under medical supervision. Afterward, subjects who wish to continue will be allowed to take the administration device home for an additional six days of use (study part 2).
During the at-home use portion of the study, subjects will use a diary to record the number of times the product was used and their nasal congestion symptoms before and after use.
At the end of the study period, subjects will return to the study center for global assessment of their impressions of treatment and to answer questions designed to estimate market acceptability. Subjects may be asked to participate voluntarily in a market research focus group following their participation in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Carbon DioxideParticipants will receive one dose of nasal carbon dioxide (CO2) in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant who demonstrate understanding of, and willingness to participate in the study
- Aged at least 18 years.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee
- Participant has perception of Nasal Breathing score ≤70 mm (Visual Analogue Scale) on the evaluation day
Key exclusion criteria (7 listed)
- Women who are known to be pregnant or who have a positive pregnancy test, or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Recent history (within the last 2 years) of alcohol or other substance abuse.
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 |
|---|---|---|
| Carbon DioxideNasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds | Drug | Treatment Group |
Primary outcome
Which One Product That Relieves Nasal Congestion do You Buy Most Often?
Time frame: 7 days
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked as part of screening survey prior to concept viewing. If the participant answered "I do not purchase any product to relieve congestion" the participant was excluded. Participants could select only one option available.
Which of the Statements Best Describes the Extent to Which the Spray Reached Your Expectations?
Time frame: 7 days
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first use. Participants could select only one option.
If the Product You Just Tried (After First Dose) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?
Time frame: 7 days
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.
Would You be Interested in Taking the Spray Product Home and Using it Over the Next Week?
Time frame: 7 days
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.
Which of the Following Statements Best Describes the Extent to Which the Spray Reached Your Expectations?
Time frame: 7 days
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
Divide 11 Points Between Two Products (CO2 Nasal Spray and Brand Selected at Q1)?
Time frame: 7 days
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option. It was done to compare the spray with the product selected by the participant in Q1. There were 11 points between the two products that participants could divide anyways thet wanted (11-0, 10-1, 9-2, 8-3, 7-4 or 6-5 etc). The more the participant liked a product compared to other, the higher the number of points were to be given to that product.
If the Product You Just Tried (After At-home Use) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?
Time frame: 7 days
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
How Many Packages Would You Buy?
Time frame: 7 days
There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience.This question was asked after at-home use of the product. Participants could select only one option.
Which One Statement Best Describes How Often, if Ever, You Think You Would Buy the Spray Product in the Future?
Time frame: 7 days
There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
How Often do You Think This Spray Product Would Last for You Personally?
Time frame: 7 days
There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
Provide a Score From 1-7 to Some Statements, Depending on How Much You Think Each Statement Applies or Does Not Apply to the Spray Product That You Used
Time frame: 7 days
A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it. You can use any score from 1 to 7 to indicate how much or how little you think the statement applies to this product
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27178892Johnson SM, Hamilton AM, Lauersen LA. A phase IV, single-center, crossover evaluation of the efficacy of an external nasal dilator strip in children with nasal congestion. Allergy Asthma Proc. 2016 May;37(3):242-7. doi: 10.2500/aap.2016.37.3950.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carbon Dioxide in people with Nasal Congestion, run by GlaxoSmithKline at 4 sites in United States.
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 6 inclusion and 7 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Which One Product That Relieves Nasal Congestion do You Buy Most Often? (time frame: 7 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02113449, which also lists 1 linked publication.
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 30 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.