Market Potential of Carbon Dioxide Nasal Spray

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Nasal Congestion

Treatments: Drug: Carbon Dioxide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02113449

202181

RH01910 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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147 participants in 1 patient group

Treatment Group

Experimental group

Description:

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.

Treatment:

Drug: Carbon Dioxide