Market Potential of Carbon Dioxide Nasal Spray

NCT ID: NCT02113449

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-02-28

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.

Conditions

Nasal Congestion

Keywords

Carbon Dioxide, Allergy symptoms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

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.

Group Type: EXPERIMENTAL

Carbon Dioxide

Intervention Type: DRUG

Nasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds

Interventions

Carbon Dioxide

Nasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Radiant Research - Chandler, AZ

Chandler, Arizona, United States

Radiant Research - Pinellas Park, FL

Pinellas Park, Florida, United States

TKL Research Inc

Paramus, New Jersey, United States

Radiant Research - Cincinnati

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27178892 (View on PubMed)

Other Identifiers

RH01910

Identifier Type: OTHER

Identifier Source: secondary_id

202181

Identifier Type: -

Identifier Source: org_study_id