The Effect of Nasal Carbon Dioxide (CO2) on Nasal Congestion in Subjects With Perennial Allergic Rhinitis

Perennial Allergic Rhinitis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Effect of Nasal Carbon Dioxide on Nasal Congestion Via Acoustic Rhinometry in Subjects With Perennial Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638755
• Other study ID #: C213
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2008
• Last updated: August 17, 2010
• Start date: February 2008
• Est. completion date: July 2008

Study information

• Verified date: August 2010
• Source: Capnia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of nasal CO2 on nasal congestion and other symptoms related to Perennial Allergic Rhinitis.

Description:

A randomized study to evaluated the safety and effect of nasal carbon dioxide on nasal congestion using acoustic rhinometry in subjects with perennial allergic rhinitis. The acoustic rhinometry is an instrument that will be used to assess the levels of the nasal congestion in each subject. Approximately 20 men and women ages 19-65 years old who have a history consistent with perennial allergic rhinitis requiring pharmacology for at least 2 years and meet all other eligibility criteria will be enrolled in this study. There will be six (6) visits to the clinic. There will be a screening visit, four (4) treatment visits, and an end of study visit. A subject's participation in the study may last up to 58 days. There will be four different doses given in this study. Each subject will receive 3 different doses of the study drug and one dose of the placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have a history consistent with minimal 2 year history of perennial allergic rhinitis requiring pharmacotherapy.

• Positive skin test to perennial allergens (e.g. cats, dogs, house dust mite, etc.)

• Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test

Exclusion Criteria:

• History of asthma (other than mild or intermittent)

• Clinically significant nasal disorders

• Acute or significant sinusitis or upper respiratory infection within 14 days of randomization

• Have an existing serious medical condition (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study

• Use of certain medication s prior to randomization and during study participation

• Participation in prior study with Nasal CO2

• Participation in another clinical study within 30 days of planned randomization date and for the duration of the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Nasal Carbon Dioxide
Nasal Carbon Dioxide
• Nasal Carbon Dioxide
Nasal Carbon Dioxide
• Nasal Carbon Dioxide
Nasal Carbon Dioxide
• Nasal Carbon Dioxide
Nasal Carbon Dioxide

Locations

Country	Name	City	State
United States	Capnia Investigative Site	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Capnia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the dose-related effects of CO2 on nasal congestion assessed by acoustic rhinometry.		Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours	Yes
Secondary	Change from baseline in olfactory test scores post-treatment		Baseline, Post Treatment: 1 hour & 3 hours	Yes
Secondary	TNSS, TNNSS, and TSS comparisons at multiple timepoints		Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, 24 hours	Yes