Last updated: 11/03/2018 22:15:42
Market Potential of Carbon Dioxide Nasal Spray
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Study to Assess the Market Potential of a Carbon Dioxide Nasal Spray in Congested Subjects
Trial description: 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 ofthe 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 beadministered 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Which one product that relieves nasal congestion do you buy most often?
Timeframe: 7 days
Which of the statements best describes the extent to which the spray reached your expectations?
Timeframe: 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?
Timeframe: 7 days
Would you be interested in taking the spray product home and using it over the next week?
Timeframe: 7 days
Which of the following statements best describes the extent to which the spray reached your expectations?
Timeframe: 7 days
Divide 11 points between two products (CO2 nasal spray and brand selected at Q1)?
Timeframe: 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?
Timeframe: 7 days
How many packages would you buy?
Timeframe: 7 days
Which one statement best describes how often, if ever, you think you would buy the spray product in the future?
Timeframe: 7 days
How often do you think this spray product would last for you personally?
Timeframe: 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
Timeframe: 7 days
Secondary outcomes:
Not applicable
Interventions:
Drug: Carbon Dioxide
Enrollment:
147
Observational study model:
Not applicable
Primary completion date:
2014-03-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Nasal Congestion
Product
GR163127
Collaborators
Not applicable
Study date(s)
November 2013 to February 2014
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Participant who demonstrate understanding of, and willingness to participate in the study
- Aged at least 18 years.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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 location(s)
Location
Radiant Research - Pinellas Park, FL
Pinellas Park, FL, United States, Not Available
Status
Study Complete
Location
Radiant Research - Cincinnati
Cincinnati, OH, United States, 45249
Status
Study Complete
Location
Radiant Research - Chandler, AZ
Chandler, AZ, United States, 85224
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2014-03-02
Actual study completion date
2014-03-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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