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Trial record 8 of 1686 for:    CARBON DIOXIDE AND dioxide

Market Potential of Carbon Dioxide Nasal Spray

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02113449
Recruitment Status : Completed
First Posted : April 14, 2014
Results First Posted : October 7, 2014
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Nasal Congestion Drug: Carbon Dioxide Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Assess the Market Potential of a Carbon Dioxide Nasal Spray in Congested Subjects
Study Start Date : November 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
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.
Drug: Carbon Dioxide
Nasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113449


Locations
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United States, Arizona
Radiant Research - Chandler, AZ
Chandler, Arizona, United States, 85224
United States, Florida
Radiant Research - Pinellas Park, FL
Pinellas Park, Florida, United States
United States, New Jersey
TKL Research Inc
Paramus, New Jersey, United States, 07652
United States, Ohio
Radiant Research - Cincinnati
Cincinnati, Ohio, United States, 45249
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02113449     History of Changes
Other Study ID Numbers: 202181
RH01910 ( Other Identifier: GSK )
First Posted: April 14, 2014    Key Record Dates
Results First Posted: October 7, 2014
Last Update Posted: April 30, 2015
Last Verified: April 2015
Keywords provided by GlaxoSmithKline:
Carbon Dioxide, Allergy symptoms