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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Seasonal Allergic Rhinitis	Drug: Nasal CO2; Drug: Placebo	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	453 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	July 2008
Actual Primary Completion Date :	October 2008
Actual Study Completion Date :	November 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. The mean change in reflective Total Nasal Symptom Score (TNSS) over the Treatment Period compared to baseline in nasal CO2 or placebo [ Time Frame: 14 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Capnia, Inc.

Investigators

Study Chair:	S. David Miller, MD	Northeast Medical Research Associates, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Kristen Yen, Associate Director, Clinical, Capnia, Inc.
ClinicalTrials.gov Identifier:	NCT00688441 History of Changes
Other Study ID Numbers:	C215
First Posted:	June 3, 2008
Last Update Posted:	August 20, 2010
Last Verified:	August 2010

Keywords provided by Capnia, Inc.:

Randomized; Double-Blind; Multi-Center; Placebo-Controlled; Phase II; Nasal Carbon Dioxide	Carbon Dioxide; Efficacy; Safety; Total Nasal Symptom Score; RQLQ

Additional relevant MeSH terms:

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