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Carbon Dioxide

Phase 2FDA approved

Nasal Congestion | Small molecule | ENT |GSK plc|Trials Updated: Apr 30, 2015

Carbon Dioxide development status

FDA approval on record Jul 5, 2013 as Carbon Dioxide, Usp
Approval holderLinde North America Inc
ApplicationNDA205764
Highest phase Phase 2
Registered trials 1 across 1 sponsor since Apr 2014

Carbon Dioxide target and mechanism

Molecular targetGSK3A, GSK3B, IMPA1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment147

FDA Designations

No designations recorded

Carbon Dioxide clinical trials

Carbon Dioxide · 1 trial · 1 indication

Phase 2 1
NCT02113449Market Potential of Carbon Dioxide Nasal SprayNasal Congestion
COMPLETED147 Analytics
PHASE2COMPLETED
Market Potential of Carbon Dioxide Nasal Spray
Nasal CongestionUnlock trial analytics

Study Endpoints

Primary Endpoints

Which One Product That Relieves Nasal Congestion do You Buy Most Often?
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?
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?
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?
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?
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)?
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?
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?
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?
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?
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
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

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment GroupEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
Carbon DioxideDRUGNasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

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 ...

Countries:United States
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Frequently asked questions about Carbon Dioxide

What is Carbon Dioxide used for?

Carbon dioxide is being developed by GSK plc as a nasal spray for nasal congestion. It is in Phase 2 clinical development in the ENT therapeutic area. The completed Phase 2 trial NCT02113449 studied 147 adults with nasal congestion in the United States. It is investigational and not approved.

What does Carbon Dioxide target?

Carbon dioxide is designed to inhibit GSK3A, GSK3B, and IMPA1. These targets belong to the inhibitor class. By acting on these molecular targets, the small molecule formulation is intended to address nasal congestion. The precise downstream effects on congestion have not been established in the completed Phase 2 study.

Who makes Carbon Dioxide?

GSK plc, which trades under the ticker GSK, is developing carbon dioxide as a nasal spray for nasal congestion. The company is the sponsor of the Phase 2 program. No partnership or licensing details for this asset have been disclosed.

What phase is Carbon Dioxide in?

Carbon dioxide is in Phase 2 development for nasal congestion. The only listed trial, NCT02113449, is completed and enrolled 147 participants. There are no active trials at this time. The asset remains investigational and has not been approved by the FDA.

What clinical trials is Carbon Dioxide in?

Carbon dioxide has been studied in one completed Phase 2 trial, NCT02113449, titled Market Potential of Carbon Dioxide Nasal Spray. It enrolled 147 adults aged 18 years and older of all sexes with nasal congestion in the United States. The trial was uncontrolled, non-randomized, and not blinded.