The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Seasonal Allergic Rhinitis

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Nasal Carbon Dioxide in the Treatment of Seasonal Allergic Rhinitis

The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of Seasonal Allergic Rhinitis

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Nasal CO2; Drug: Placebo

Detailed Description

This multi-center, randomized, double-blind, placebo-controlled, parallel group trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (CO2) in patients with seasonal allergic rhinitis. An estimated 500 patients who meet the eligibility criteria will be enrolled into this study at approximately 25 sites to ensure that approximately 400 patients are randomized and complete the study.

• Study Type: Interventional
• Enrollment (Actual): 453
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to read and understand informed consent and voluntarily consent to sign the informed consent form
• Able to comply with the requirements of the protocol (e.g., complete the diary within the protocol-specified window)
• Minimal 2-year history of Fall seasonal allergic rhinitis requiring pharmacotherapy
• Positive skin test to one or more Fall seasonal allergen (e.g., ragweed, birch pollen, 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 intermittent)
• Acute or significant sinusitis or upper respiratory infection within 14 days of enrollment
• Existing serious medical condition (e.g., severe emphysema) that precludes participation
• Females who are pregnant or breast-feeding and/or who plan to become pregnant or to breast-feed during the study participation or within 7 days after the last study drug administration
• Initiation of immunotherapy or have a change in immunotherapy dose within the 6 months preceding enrollment (if on immunotherapy, the same dose must be maintained throughout the trial)
• Planned travel outside the study area for the duration of study period
• Participation in another clinical study within 30 days of planned enrollment date and for the duration of the study
• Participation in a previous study with Nasal CO2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; CO2 Gas	Drug: Nasal CO2; Twice daily during the 14 day Treatment Period
Placebo Comparator: Placebo; Inactive Placebo Gas	Drug: Placebo; Use of the study drug dispenser at the same frequency as the active arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The mean change in reflective Total Nasal Symptom Score (TNSS) over the Treatment Period compared to baseline in nasal CO2 or placebo	14 days

Collaborators and Investigators

• Sponsor: Capnia, Inc.
• Investigators: Study Chair: S. David Miller, MD, Northeast Medical Research Associates, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: May 29, 2008
• First Submitted That Met QC Criteria: May 29, 2008
• First Posted (Estimate): June 3, 2008

Study Record Updates

• Last Update Posted (Estimate): August 20, 2010
• Last Update Submitted That Met QC Criteria: August 18, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Double-Blind; Randomized; Phase II; Placebo-Controlled; Multi-Center; Nasal Carbon Dioxide; Carbon Dioxide; Total Nasal Symptom Score; RQLQ
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: C215