Conditions: Nasal Congestion
Keywords: Carbon Dioxide, Allergy symptoms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 147
Healthy volunteers: no

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.

Arms:
arm 1: Participants 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: intervention 1: Carbon Dioxide
Intervention descriptions: intervention 1: Nasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds

Protocol document: