Market Potential of Carbon Dioxide Nasal Spray

Nasal Congestion Clinical Trial

Official title:

A Study to Assess the Market Potential of a Carbon Dioxide Nasal Spray in Congested Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113449
• Other study ID #: 202181
• Secondary ID: RH01910
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2014
• Last updated: April 9, 2015
• Start date: November 2013
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Congestion

Intervention

Drug:
• Carbon Dioxide
Nasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds

Locations

Country	Name	City	State
United States	Radiant Research - Chandler, AZ	Chandler	Arizona
United States	Radiant Research - Cincinnati	Cincinnati	Ohio
United States	TKL Research Inc	Paramus	New Jersey
United States	Radiant Research - Pinellas Park, FL	Pinellas Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days	No
Primary	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.	7 days	No
Primary	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.	7 days	No
Primary	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.	7 days	No
Primary	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.	7 days	No
Primary	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.	7 days	No
Primary	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.	7 days	No
Primary	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.	7 days	No
Primary	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.	7 days	No
Primary	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.	7 days	No
Primary	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	7 days	No