Phase 2
N=147
Market Potential of Carbon Dioxide Nasal Spray
Nasal Congestion
Bottom Line
View on ClinicalTrials.gov: NCT02113449 ↗Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Which One Product That Relieves Nasal Congestion do You Buy Most Often? — 46; 29; 6; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carbon Dioxide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Which One Product That Relieves Nasal Congestion do You Buy Most Often? |
46; 29; 6; 3; 14; 6 | — |
| PRIMARY Which of the Statements Best Describes the Extent to Which the Spray Reached Your Expectations? |
45; 48; 27; 9; 4 | — |
| 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? |
29; 50; 40; 9; 5 | — |
| PRIMARY Would You be Interested in Taking the Spray Product Home and Using it Over the Next Week? |
133; 0 | — |
| PRIMARY Which of the Following Statements Best Describes the Extent to Which the Spray Reached Your Expectations? |
43; 35; 22; 16; 17 | — |
| PRIMARY Divide 11 Points Between Two Products (CO2 Nasal Spray and Brand Selected at Q1)? |
12; 4; 5; 5; 13; 13 | — |
| 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? |
40; 38; 21; 18; 16 | — |
| PRIMARY How Many Packages Would You Buy? |
54; 20; 6; 1; 1; 51 | — |
| PRIMARY Which One Statement Best Describes How Often, if Ever, You Think You Would Buy the Spray Product in the Future? |
43; 2; 16; 9; 30; 10 | — |
| PRIMARY How Often do You Think This Spray Product Would Last for You Personally? |
2; 17; 17; 28; 15; 10 | — |
| 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 |
2; 2; 5; 5; 22; 15 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02113449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.