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

NCT00638755 | Completed Phase 2

• 1 other identifier: C213
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perennial Allergic Rhinitis

Keywords

Allergic Rhinitis; Perennial Allergic Rhinitis; Allergies to perennial allergens; Allergies to perennial allergens (e.g. dog, cat, dust mites, etc.)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change from baseline in olfactory test scores post-treatment

  Baseline, Post Treatment: 1 hour & 3 hours

• 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

Study Arms (4)

1

EXPERIMENTAL

The following treatment sequence: A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo)

Drug: Nasal Carbon Dioxide

2

EXPERIMENTAL

The following treatment sequence: B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide)

Drug: Nasal Carbon Dioxide

3

EXPERIMENTAL

The following treatment sequence: C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide)

Drug: Nasal Carbon Dioxide

4

EXPERIMENTAL

The following treatment sequence: D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide)

Drug: Nasal Carbon Dioxide

Interventions

Nasal Carbon Dioxide DRUG

Nasal Carbon Dioxide

1

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capnia, Inc.: lead

Study Sites (1)

Capnia Investigative Site

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Capnia Clinical Study Investigator

  Capnia Investigative Site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 13, 2008
• First Posted: March 19, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 19, 2010

Record last verified: 2010-08

Locations

US (1)