Clinical trial NCT02113449: Market Potential of Carbon Dioxide Nasal Spray
Official title: A Study to Assess the Market Potential of a Carbon Dioxide Nasal Spray in Congested Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasal Congestion
Keywords: Carbon Dioxide, Allergy symptoms
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Which One Product That Relieves Nasal Congestion do You Buy Most Often?
timeFrame: 7 days
measure: Which of the Statements Best Describes the Extent to Which the Spray Reached Your Expectations?
timeFrame: 7 days
measure: 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
measure: Would You be Interested in Taking the Spray Product Home and Using it Over the Next Week?
timeFrame: 7 days
measure: Which of the Following Statements Best Describes the Extent to Which the Spray Reached Your Expectations?
timeFrame: 7 days
measure: Divide 11 Points Between Two Products (CO2 Nasal Spray and Brand Selected at Q1)?
timeFrame: 7 days
measure: 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
measure: How Many Packages Would You Buy?
timeFrame: 7 days
measure: Which One Statement Best Describes How Often, if Ever, You Think You Would Buy the Spray Product in the Future?
timeFrame: 7 days
measure: How Often do You Think This Spray Product Would Last for You Personally?
timeFrame: 7 days
measure: 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:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Radiant Research - Chandler, AZ
state: Arizona
city: Pinellas Park
country: United States
facility: Radiant Research - Pinellas Park, FL
state: Florida
city: Paramus
country: United States
facility: TKL Research Inc
state: New Jersey
city: Cincinnati
country: United States
facility: Radiant Research - Cincinnati
state: Ohio
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.