Market Potential of Carbon Dioxide Nasal Spray

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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